Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling.

PubMed

Wang, Yefeng; Gunashekar, Divya R; Adam, Terrence J; Zhang, Rui

2017-01-01

The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Data-base (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements.

Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling

PubMed Central

Wang, Yefeng; Gunashekar, Divya R.; Adam, Terrence J.; Zhang, Rui

2018-01-01

The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Database (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements. PMID:29295169

Commonly Used Dietary Supplements on Coagulation Function during Surgery.

PubMed

Wang, Chong-Zhi; Moss, Jonathan; Yuan, Chun-Su

2015-09-01

Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information of potential complications of dietary supplements during perioperative management is important for physicians. Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John's wort, and valerian) and 4 other dietary supplements (coenzyme Q 10 , glucosamine and chondroitin sulfate, fish oil, and vitamins). Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John's wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet function are difficult to predict, it is prudent to advise their discontinuation before surgery.

Anticoagulant activity of select dietary supplements.

PubMed

Stanger, Michael J; Thompson, Lauren A; Young, Andrew J; Lieberman, Harris R

2012-02-01

This review considers the potential of certain dietary supplements, including garlic, Ginkgo biloba, ginger, ginseng, fish oil, and vitamin E, to interfere with hemostasis. Dietary supplements are common components of the diet in the United States, with about half the US adult population taking some type of dietary supplement regularly. It has been suggested that some supplements could adversely affect coagulation when taken alone or in combination with antiplatelet medications. Supplements could alter hemostasis by a variety of mechanisms, such as reducing platelet aggregation or inhibiting arachidonic acid, a cellular signaling messenger and inflammatory intermediate. To conduct this review, multiple databases were searched using a variety of search terms to ensure relevant papers were located. Moderate to severe adverse events, such as spinal epidural hematoma, spontaneous intracerebral hemorrhage, retrobulbar hemorrhage, subarachnoid hemorrhage, spontaneous hyphema, and postoperative bleeding, have occasionally been anecdotally associated with consumption of dietary supplements. However, the number of controlled studies in the literature is too limited to demonstrate consistent anticoagulant effects of dietary supplements alone or in combination with drug therapy. © 2012 International Life Sciences Institute.

Iodine in food and dietary supplement composition databases

USDA-ARS?s Scientific Manuscript database

For a number of years, the U.S. Food and Drug Administration (FDA) and the Nutrient Data Laboratory (NDL) of the U.S. Department of Agriculture’s Agricultural Research Service have worked independently on determining the iodine content of foods and dietary supplements and are now harmonizing their e...

Dietary Supplement Ingredient Database (DSID) release 4.0

USDA-ARS?s Scientific Manuscript database

Nearly half of U.S. adults report taking dietary supplements (DS). A single serving of a DS may contain amounts of nutrients or other bioactive compounds that exceed their concentration in foods. During the manufacturing of DS, ingredients may be added in amounts exceeding the label claims in orde...

Dietary Supplement Label Database (DSLD)

Science.gov Websites

Intakes (DRIs) Definitions Frequently Asked Questions (FAQ) Information Sources Release Notes Help Search full label derived information from dietary supplement products marketed in the U.S. with a Web-based user interface that provides ready access to label information. It was developed to serve the research

A free new dietary supplement label database for dietitians

USDA-ARS?s Scientific Manuscript database

Over half of US adults consume dietary supplements (DS). Some of the approximately 50,000 products on the market provide significant sources of nutrients or other bioactive constituents. It is important for dietitians to have information about them. In keeping with their missions, the Office of Di...

Patient use of dietary supplements: a clinician's perspective.

PubMed

Sadovsky, Richard; Collins, Nancy; Tighe, Ann P; Brunton, Stephen A; Safeer, Richard

2008-04-01

The estimated prevalence of dietary-supplement use among US adults was 73% in 2002. Appropriate use of dietary supplements within the paradigm of evidence-based medicine may be a challenge for medical doctors and non-physician clinicians. Randomized, controlled, clinical trial data, which are considered the gold standard for evidence-based decision making, are lacking. Standardized guidelines for the use of dietary supplements are lacking, and dietary supplements can bear unsupported claims. This article is intended to review clinically-relevant issues related to the widespread use of dietary supplements, with emphasis on regulatory oversight and safety. Review articles and clinical trial articles published up until December 2007 were selected based on a search of the MEDLINE electronic database using PubMed. The Food and Drug Administration (FDA) Website was also used as a resource. We used the search terms dietary supplement(s), vitamin supplements, mineral supplements, and Dietary Supplement and Health Education Act. Articles discussing dietary supplements and their regulation, prevalence of use, prescription and nonprescription formulations, and/or adverse events were selected for review. Articles discussing one or more of these topics in adults were selected for inclusion. New FDA regulations require dietary-supplement manufacturers to evaluate the identity, purity, strength, and composition of their products. However, these regulations are not designed to demonstrate product efficacy and safety, and dietary-supplement manufacturers are not required to submit efficacy and safety data to the FDA prior to marketing. Product contamination and/or mislabeling may undermine the integrity of dietary-supplement formulations. The use of dietary supplements may be associated with adverse events. Although there are new regulatory requirements for dietary supplements, these products will not require FDA approval or submission of efficacy and safety data prior to marketing under the new regulation. A limitation to the literature used for this review is the lack of prospective, randomized clinical trials on the safety and efficacy of dietary supplements. Clinicians should be aware of all the dietary supplements that their patients consume, and help their patients make informed decisions appropriate to their medical care.

Interaction of Carbamazepine with Herbs, Dietary Supplements, and Food: A Systematic Review

PubMed Central

Zuo, Zhong

2013-01-01

Background. Carbamazepine (CBZ) is a first-line antiepileptic drug which may be prone to drug interactions. Systematic review of herb- and food-drug interactions on CBZ is warranted to provide guidance for medical professionals when prescribing CBZ. Method. A systematic review was conducted on six English databases and four Chinese databases. Results. 196 out of 3179 articles fulfilled inclusion criteria, of which 74 articles were reviewed and 33 herbal products/dietary supplement/food interacting with CBZ were identified. No fatal or severe interactions were documented. The majority of the interactions were pharmacokinetic-based (80%). Traditional Chinese medicine accounted for most of the interactions (n = 17), followed by food (n = 10), dietary supplements (n = 3), and other herbs/botanicals (n = 3). Coadministration of 11 and 12 of the studied herbal products/dietary supplement/food significantly decreased or increased the plasma concentrations of CBZ. Regarding pharmacodynamic interaction, Xiao-yao-san, melatonin, and alcohol increased the side effects of CBZ while caffeine lowered the antiepileptic efficacy of CBZ. Conclusion. This review provides a comprehensive summary of the documented interactions between CBZ and herbal products/food/dietary supplements which assists healthcare professionals to identify potential herb-drug and food-drug interactions, thereby preventing potential adverse events and improving patients' therapeutic outcomes when prescribing CBZ. PMID:24023584

Commonly Used Dietary Supplements on Coagulation Function during Surgery

PubMed Central

Wang, Chong-Zhi; Moss, Jonathan; Yuan, Chun-Su

2015-01-01

Abstract Background Patients who undergo surgery appear to use dietary supplements significantly more frequently than the general population. Because they contain pharmacologically active compounds, dietary supplements may affect coagulation and platelet function during the perioperative period through direct effects, pharmacodynamic interactions, and pharmacokinetic interactions. However, in this regard, limited studies have been conducted that address the pharmacological interactions of dietary supplements. To avoid possible bleeding risks during surgery, information about the potential complications of dietary supplements during perioperative management is important for physicians. Methods Through a systematic database search of all available years, articles were identified in this review if they included dietary supplements and coagulation/platelet function, while special attention was paid to studies published after 1990. Results Safety concerns are reported in commercially available dietary supplements. Effects of the most commonly used natural products on blood coagulation and platelet function are systematically reviewed, including 11 herbal medicines (echinacea, ephedra, garlic, ginger, ginkgo, ginseng, green tea, kava, saw palmetto, St John’s wort, and valerian) and four other dietary supplements (coenzyme Q10, glucosamine and chondroitin sulfate, fish oil, and vitamins). Bleeding risks of garlic, ginkgo, ginseng, green tea, saw palmetto, St John’s wort, and fish oil are reported. Cardiovascular instability was observed with ephedra, ginseng, and kava. Pharmacodynamic and pharmacokinetic interactions between dietary supplements and drugs used in the perioperative period are discussed. Conclusions To prevent potential problems associated with the use of dietary supplements, physicians should be familiar with the perioperative effects of commonly used dietary supplements. Since the effects of dietary supplements on coagulation and platelet function are difficult to predict, it is prudent to advise their discontinuation before surgery. PMID:26949700

Dietary supplement research portfolio at the NIH, 2009-2011.

PubMed

Garcia-Cazarin, Mary L; Wambogo, Edwina A; Regan, Karen S; Davis, Cindy D

2014-04-01

The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009-2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement-related funding for FYs 2009-2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women's reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements.

Levels of the Antioxidant Nutrients Vitamin C, Vitamin E, and Selenium in the Dietary Supplement Ingredient Database: NHANES Data Applications

USDA-ARS?s Scientific Manuscript database

Laboratory evidence indicates that antioxidants may slow or possibly prevent the development of certain cancers by protecting cells from damage caused by free radicals or other mechanisms. Many dietary supplements containing antioxidant constituents (e.g., vitamin C) are available to consumers. Th...

Dietary Supplement Research Portfolio at the NIH, 2009–201112

PubMed Central

Garcia-Cazarin, Mary L.; Wambogo, Edwina A.; Regan, Karen S.; Davis, Cindy D.

2014-01-01

The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009–2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement–related funding for FYs 2009–2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women’s reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements. PMID:24523489

Total Antioxidant Capacity from Dietary Supplement Decreases the Likelihood of Having Metabolic Syndrome in Korean Adults.

PubMed

Kim, Subeen; Song, YoonJu; Lee, Jung Eun; Jun, Shinyoung; Shin, Sangah; Wie, Gyung-Ah; Cho, Yoon Hee; Joung, Hyojee

2017-09-22

This study was conducted to estimate antioxidant vitamin intake and total antioxidant capacity (TAC) from diet and dietary supplements and to examine their association with metabolic syndrome (MetS) in Korean adults. Out of 6308 adults 19~64 years old from the 2010~2011 Korea National Health and Nutrition Examination Survey, 1847 adults were classified as dietary supplement users and the other 4461 adults were classified as non-users. Antioxidant intake and TAC from diet and dietary supplements were estimated using dietary intake data and linked with the antioxidant and TAC database for common Korean foods. The prevalence of MetS was lower in dietary supplement users (odds ratio (OR) = 0.82; 95% confidence interval (CI), 0.68-0.98) than that in non-users. Among dietary supplement users, a lower prevalence of MetS was observed in the highest tertile for vitamin A (OR = 0.72; 95% CI, 0.53-0.99) and vitamin E (OR = 0.74; 95% CI, 0.55- 0.99) intake than that in the lowest tertile among non-users. Subjects in the highest tertile of TAC among dietary supplement users showed a lower prevalence of MetS (OR = 0.72; 95% CI, 0.52-0.99) than non-users. The results imply that intake of vitamin A, vitamin E, and TAC from dietary supplements might have a protective effect on MetS among Korean adults.

Prohibited Contaminants in Dietary Supplements.

PubMed

Mathews, Neilson M

With the increasing use of unregulated dietary supplements, athletes are at continued risk from adverse medical events and inadvertent doping. A review of Clinical Key, MEDLINE, and PubMed databases from 2012 to 2017 was performed using search terms, including dietary supplement, contamination, doping in athletes, inadvertent doping, and prohibited substances. The references of pertinent articles were reviewed for other relevant sources. Clinical review. Level 3. Poor manufacturing processes and intentional contamination with many banned substances continue to occur in dietary supplements sold in the United States. Certain sectors, such as weight loss and muscle-building supplements, pose a greater threat because they are more likely to be contaminated. Athletes will continue to be at risk for adverse events and failed doping tests due to contaminated dietary supplements until legislation changes how they are regulated. In the interim, there are several steps that can be taken to mitigate this risk, including improved education of medical staff and athletes and use of third party-certified products.

Effects of herbal and dietary supplements on cognition in menopause: a systematic review.

PubMed

Clement, Yuri N; Onakpoya, Igho; Hung, Shao K; Ernst, Edzard

2011-03-01

Many postmenopausal women use herbal remedies and dietary supplements to counteract menopausal symptoms, including the decline in cognitive function. The aim of this systematic review is to evaluate the evidence regarding the efficacy of herbal and dietary supplements on cognition in menopause. Randomized clinical trials (RCTs) of herbal medicines and dietary supplements were identified using the Medline, EMBASE, AMED, PsycINFO, CINAHL and The Cochrane Library 2010 (Issue 2) electronic databases and by hand searches. Data were independently extracted and evaluated by two reviewers. Risk of bias was assessed by two independent reviewers using the Cochrane Collaboration tool. Twelve RCTs were included and five of these suggest that isoflavone, soy and Gingko biloba supplementation may improve cognition in postmenopausal women. However, most of the included studies had serious methodological flaws which demand a cautious interpretation of these findings. The evidence that herbal and dietary supplements might positively affect the cognitive decline during the menopause is not compelling. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Iodine in food- and dietary supplement–composition databases123

PubMed Central

Pehrsson, Pamela R; Patterson, Kristine Y; Spungen, Judith H; Wirtz, Mark S; Andrews, Karen W; Dwyer, Johanna T; Swanson, Christine A

2016-01-01

The US Food and Drug Administration (FDA) and the Nutrient Data Laboratory (NDL) of the USDA Agricultural Research Service have worked independently on determining the iodine content of foods and dietary supplements and are now harmonizing their efforts. The objective of the current article is to describe the harmonization plan and the results of initial iodine analyses accomplished under that plan. For many years, the FDA’s Total Diet Study (TDS) has measured iodine concentrations in selected foods collected in 4 regions of the country each year. For more than a decade, the NDL has collected and analyzed foods as part of the National Food and Nutrient Analysis Program; iodine analysis is now being added to the program. The NDL recently qualified a commercial laboratory to conduct iodine analysis of foods by an inductively coupled plasma mass spectrometry (ICP-MS) method. Co-analysis of a set of samples by the commercial laboratory using the ICP-MS method and by the FDA laboratory using its standard colorimetric method yielded comparable results. The FDA recently reviewed historical TDS data for trends in the iodine content of selected foods, and the NDL analyzed samples of a limited subset of those foods for iodine. The FDA and the NDL are working to combine their data on iodine in foods and to produce an online database that can be used for estimating iodine intake from foods in the US population. In addition, the NDL continues to analyze dietary supplements for iodine and, in collaboration with the NIH Office of Dietary Supplements, to publish the data online in the Dietary Supplement Ingredient Database. The goal is to provide, through these 2 harmonized databases and the continuing TDS focus on iodine, improved tools for estimating iodine intake in population studies. PMID:27534627

Analytical content and variability of vitamins and minerals in adult multivitamin/mineral products: national estimates for the Dietary Supplement Ingredient Database (DSID)

USDA-ARS?s Scientific Manuscript database

Multivitamin/mineral products (MVMs) are the most commonly reported dietary supplements used by adults in the United States. During manufacturing, some MVM ingredients are added in amounts exceeding the label claims in order to compensate for losses during the shelf life. Establishing the health be...

The ethics of dietary supplements and natural health products in pharmacy practice: a systematic documentary analysis.

PubMed

Boon, Heather; Hirschkorn, Kristine; Griener, Glenn; Cali, Michelle

2009-02-01

Many natural health products and dietary supplements are purchased in pharmacies and it has been argued that pharmacists are in the best position to provide patients with evidence-based information about them. This study was designed to identify how the pharmacist's role with respect to natural health products and dietary supplements is portrayed in the literature. A systematic search was conducted in a variety of health databases to identify all literature that pertained to both pharmacy and natural health products and dietary supplements. Of the 786 articles identified, 665 were broad-coded and 259 were subjected to in-depth qualitative content analysis for emergent themes. Overwhelmingly, support for the sale of natural health products and dietary supplements in pharmacies is strong. Additionally, a role for pharmacist counselling is underscored. But another recurrent theme is that pharmacists are ill-equipped to counsel patients about these products that are available on their shelves. This situation has led some to question the ethics of pharmacists selling natural health products and dietary supplements and to highlight the existence of an ethical conflict stemming from the profit-motive associated with sales of natural health products and dietary supplements. This analysis raises concerns about the ethics of natural health products and dietary supplements being sold in pharmacies, and about pharmacists being expected to provide counselling about products of which they have little knowledge.

A Review of the Toxicity of Compounds Found in Herbal Dietary Supplements.

PubMed

Hudson, Amy; Lopez, Elizabeth; Almalki, Ahmad J; Roe, Amy L; Calderón, Angela I

2018-07-01

Use of herbal dietary supplements by the public is common and has been happening for centuries. In the United States, the Food and Drug Administration has a limited scope of regulation over marketed herbal dietary supplements, which may contain toxic botanical compounds that pose a public health risk. While the Food and Drug Administration has made efforts to prohibit the sale of unsafe herbal dietary supplements, numerous reports have proliferated of adverse events due to these supplements. This literature review investigates bioactive plant compounds commonly used in herbal dietary supplements and their relative toxicities. Using primarily the National Library of Medicine journal database and SciFinder for current reports, 47 toxic compounds in 55 species from 46 plant families were found to demonstrate harmful effects due to hepatic, cardiovascular, central nervous system, and digestive system toxicity. This review further contributes a novel and comprehensive view of toxicity across the botanical dietary market, and investigates the toxicity of the top ten botanical dietary supplements purchased in the United States of America to gauge the exposure risk of toxicity to the public. The criteria of measuring toxicity in this review (plant compound, family, quantity, and toxicity effects) across the entire market in the United States, with special attention to those supplements whose exposure to the consumer is maximal, provides a unique contribution to the investigation of botanical supplements. Georg Thieme Verlag KG Stuttgart · New York.

Total Antioxidant Capacity from Dietary Supplement Decreases the Likelihood of Having Metabolic Syndrome in Korean Adults

PubMed Central

Kim, Subeen; Shin, Sangah; Cho, Yoon Hee; Joung, Hyojee

2017-01-01

This study was conducted to estimate antioxidant vitamin intake and total antioxidant capacity (TAC) from diet and dietary supplements and to examine their association with metabolic syndrome (MetS) in Korean adults. Out of 6308 adults 19~64 years old from the 2010~2011 Korea National Health and Nutrition Examination Survey, 1847 adults were classified as dietary supplement users and the other 4461 adults were classified as non-users. Antioxidant intake and TAC from diet and dietary supplements were estimated using dietary intake data and linked with the antioxidant and TAC database for common Korean foods. The prevalence of MetS was lower in dietary supplement users (odds ratio (OR) = 0.82; 95% confidence interval (CI), 0.68–0.98) than that in non-users. Among dietary supplement users, a lower prevalence of MetS was observed in the highest tertile for vitamin A (OR = 0.72; 95% CI, 0.53–0.99) and vitamin E (OR = 0.74; 95% CI, 0.55–0.99) intake than that in the lowest tertile among non-users. Subjects in the highest tertile of TAC among dietary supplement users showed a lower prevalence of MetS (OR = 0.72; 95% CI, 0.52–0.99) than non-users. The results imply that intake of vitamin A, vitamin E, and TAC from dietary supplements might have a protective effect on MetS among Korean adults. PMID:28937597

Word-of-Mouth Innovation: Hypothesis Generation for Supplement Repurposing based on Consumer Reviews.

PubMed

Fan, Jung-Wei; Lussier, Yves A

2017-01-01

Dietary supplements remain a relatively underexplored source for drug repurposing. A systematic approach to soliciting responses from a large consumer population is desirable to speed up innovation. We tested a workflow that mines unexpected benefits of dietary supplements from massive consumer reviews. A (non-exhaustive) list of regular expressions was used to screen over 2 million reviews on health and personal care products. The matched reviews were manually analyzed, and one supplement-disease pair was linked to biological databases for enriching the hypothesized association. The regular expressions found 169 candidate reviews, of which 45.6% described unexpected benefits of certain dietary supplements. The manual analysis showed some of the supplement-disease associations to be novel or in agreement with evidence published later in the literature. The hypothesis enrichment was able to identify meaningful function similarity between the supplement and the disease. The results demonstrated value of the workflow in identifying candidates for supplement repurposing.

Effectiveness of dietary supplements in spinal cord injury subjects.

PubMed

Navarrete-Opazo, Angela; Cuitiño, Pilar; Salas, Inés

2017-04-01

Individuals with spinal cord injury (SCI) consume more dietary supplements than the general population. However, there is limited information regarding the clinical effectiveness of dietary supplements in SCI population. To systematically review the effectiveness of dietary supplements for the prevention or treatment of health-related conditions associated with SCI. Randomized or non-randomized controlled clinical trials were selected, comparing the effect of any dose and form of a dietary supplement (defined by the Dietary Supplement Health and Education Act), with either no treatment, placebo, or other medication. Data Sources included the Cochrane Database, DARE, LILACS, CINAHL, EMBASE, MEDLINE, OTSeeker, PEDro, PsycINFO, SpeechBITE, ScienceDirect, Scopus, clinicaltrials.gov, Google Scholar, and OpenGrey. Two reviewers independently classified articles from January 1970 through October 2015, and 18 articles were selected. Due to the heterogeneity of outcome measures across studies, a meta-analysis was not conducted. However, high-quality evidence showed that cranberry supplementation is not effective for prevention of urinary tract infections (UTIs) in SCI. Moderate-quality evidence supported a beneficial effect of vitamin D, alpha-lipoic acid, and omega-3 supplementation, although replication of results is needed. There were conflicting results for the effect of creatine supplementation on improvement of motor outcomes. Low-quality evidence does not permit assessment of the effectiveness of melatonin, whey protein, vitamin C, and Chinese herb in SCI. There is sufficient data suggesting that cranberry supplementation is ineffective for prevention of UTIs in individuals with SCI. There is insufficient data to support or refute the use of any other dietary supplement in individuals with SCI. Copyright © 2016 Elsevier Inc. All rights reserved.

Adverse effects of herbal or dietary supplements in G6PD deficiency: a systematic review.

PubMed

Lee, Shaun Wen Huey; Lai, Nai Ming; Chaiyakunapruk, Nathorn; Chong, David Weng Kwai

2017-01-01

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common genetic disorder, affecting nearly 400 million individuals worldwide. Whilst it is known that a number of drugs, foods and chemicals can trigger haemolysis in G6PD deficient individuals, the association between herbal and dietary supplements and haemolysis is less clear. The objective of this study was to evaluate the association between herbal or dietary supplements and adverse events in G6PD deficient individuals. We searched 14 electronic databases from their inception until November 2015 for articles describing the use of herbal or dietary supplements in G6PD deficient individuals. Additional publications were identified from manually searching textbooks, conference abstracts and the grey literature. All study designs were included as long as they contained clinical information. These gathered findings were summarized narratively. Thirty-two publications met inclusion criteria. These reported on 10 herbal and dietary supplements. Overall evidence linking haemolysis to a herbal/dietary supplement was only found for henna. No evidence of harm was observed for vitamin C, vitamin E, vitamin K, Gingko biloba and α-lipoic acid. The review showed that there was insufficient evidence to contravene the use of most herbal or dietary products at therapeutic doses in G6PD deficient subjects. © 2016 The British Pharmacological Society.

The total antioxidant content of more than 3100 foods, beverages, spices, herbs and supplements used worldwide

PubMed Central

2010-01-01

Background A plant-based diet protects against chronic oxidative stress-related diseases. Dietary plants contain variable chemical families and amounts of antioxidants. It has been hypothesized that plant antioxidants may contribute to the beneficial health effects of dietary plants. Our objective was to develop a comprehensive food database consisting of the total antioxidant content of typical foods as well as other dietary items such as traditional medicine plants, herbs and spices and dietary supplements. This database is intended for use in a wide range of nutritional research, from in vitro and cell and animal studies, to clinical trials and nutritional epidemiological studies. Methods We procured samples from countries worldwide and assayed the samples for their total antioxidant content using a modified version of the FRAP assay. Results and sample information (such as country of origin, product and/or brand name) were registered for each individual food sample and constitute the Antioxidant Food Table. Results The results demonstrate that there are several thousand-fold differences in antioxidant content of foods. Spices, herbs and supplements include the most antioxidant rich products in our study, some exceptionally high. Berries, fruits, nuts, chocolate, vegetables and products thereof constitute common foods and beverages with high antioxidant values. Conclusions This database is to our best knowledge the most comprehensive Antioxidant Food Database published and it shows that plant-based foods introduce significantly more antioxidants into human diet than non-plant foods. Because of the large variations observed between otherwise comparable food samples the study emphasizes the importance of using a comprehensive database combined with a detailed system for food registration in clinical and epidemiological studies. The present antioxidant database is therefore an essential research tool to further elucidate the potential health effects of phytochemical antioxidants in diet. PMID:20096093

LactMed: Drugs and Lactation Database

MedlinePlus

... App LactMed Record Format Database Creation & Peer Review Process Help Fact Sheet Sample Record TOXNET FAQ Glossary Selected References About Dietary Supplements Breastfeeding Links Get LactMed Widget Contact Us Email: tehip@ ...

Dietary supplements containing prohibited substances.

PubMed

van der Bijl, P; Tutelyan, V A

2013-01-01

Dietary supplement use among athletes to enhance performance is proliferating as more individuals strive for obtaining that chemical competitive edge. As a result the concomitant use of dietary supplements containing performance-enhancing substances of those falling in the categories outlined in the current review, can also be expected to rise. This despite ever-increasing sophisticated analytical methodology techniques being used to assay dietary supplement and urine samples in doping laboratories. The reasons for this include that a variety of these chemical entities, many of them on the prohibited drug list of the WADA, are being produced on commercial scales in factories around the world (ephedrine and pseudoephedrine, sibutramine, methylhexaneamine, prohormones, 'classic' anabolic steroids, clenbuterol, peptide hormones etc.), aggressive marketing strategies are being employed by companies and these supplements can be easily ordered via e.g. the internet. It can also be anticipated that there will be an increase in the number of supplements containing 'designer' steroids and other 'newer' molecules. Chromatographic techniques combined with mass spectrometry leading to identification of molecular fragments and productions will assist in determining these substances. To prevent accidental doping, information regarding dietary supplements must be provided to athletes, coaches and sports doctors at all levels of competition. The risks of accidental doping via dietary supplement ingestion can be minimized by using 'safe' products listed on databases, e.g. such as those available in The Netherlands and Germany.

A systematic review of community pharmacist therapeutic knowledge of dietary supplements.

PubMed

Waddington, Freya; Naunton, Mark; Kyle, Greg; Thomas, Jackson; Cooper, Gabrielle; Waddington, Ainsley

2015-06-01

Internationally, the use of dietary supplements has been growing rapidly. Patient support for pharmacist sales of nutritional and dietary supplements is also strong. The increase in demand for nutritional and dietary supplements and subsequent advice about these products, however, makes it necessary that pharmacists maintain a contemporary knowledge of the area. This systematic review was conducted to examine the current evidence regarding the level of the nutritional and dietary supplement knowledge of community pharmacists and their understanding of their therapeutic effects. Electronic databases including Medline, Scopus, Embase, CINAHL, Scifinder and the Cochrane Controlled Trials Register were searched. Studies assessing nutritional knowledge of pharmacists in community pharmacies were eligible for inclusion. All languages and study designs were considered. Study results were analysed and pharmacist knowledge scores were given out of 100 %. Results From 5594 studies identified, nine met the inclusion criteria. Each study tested pharmacist knowledge with predetermined questions calculating results as the number of questions answered correctly. These knowledge scores were converted to a percentage score for the purpose of this paper. The median knowledge score across all papers was 64 %. A lack of studies assessing community pharmacists' knowledge of commonly sold vitamins and minerals was observed. Global community pharmacist knowledge of dietary supplements appears to be poor. Community pharmacists have an professional responsibility to provide accurate health information about dietary supplements as they do for any other therapies they provide to patients. Further research including that which assesses pharmacists' therapeutic knowledge of commonly sold vitamins and minerals is suggested.

Risk of Type 2 Diabetes Is Lower in US Adults Taking Chromium-Containing Supplements123

PubMed Central

McIver, David J; Grizales, Ana Maria; Brownstein, John S; Goldfine, Allison B

2015-01-01

Background: Dietary supplement use is widespread in the United States. Although it has been suggested in both in vitro and small in vivo human studies that chromium has potentially beneficial effects in type 2 diabetes (T2D), chromium supplementation in diabetes has not been investigated at the population level. Objective: The objective of this study was to examine the use and potential benefits of chromium supplementation in T2D by examining NHANES data. Methods: An individual was defined as having diabetes if he or she had a glycated hemoglobin (HbA1c) value of ≥6.5%, or reported having been diagnosed with diabetes. Data on all consumed dietary supplements from the NHANES database were analyzed, with the OR of having diabetes as the main outcome of interest based on chromium supplement use. Results: The NHANES for the years 1999–2010 included information on 62,160 individuals. After filtering the database for the required covariates (gender, ethnicity, socioeconomic status, body mass index, diabetes diagnosis, supplement usage, and laboratory HbA1c values), and when restricted to adults, the study cohort included 28,539 people. A total of 58.3% of people reported consuming a dietary supplement in the previous 30 d, 28.8% reported consuming a dietary supplement that contained chromium, and 0.7% consumed supplements that had “chromium” in the title. Compared with nonusers, the odds of having T2D (HbA1c ≥6.5%) were lower in persons who consumed chromium-containing supplements within the previous 30 d than in those who did not (OR: 0.73; 95% CI: 0.62, 0.86; P = 0.001). Supplement use alone (without chromium) did not influence the odds of having T2D (OR: 0.89; 95% CI: 0.77, 1.03; P = 0.11). Conclusions: Over one-half the adult US population consumes nutritional supplements, and over one-quarter consumes supplemental chromium. The odds of having T2D were lower in those who, in the previous 30 d, had consumed supplements containing chromium. Given the magnitude of exposure, studies on safety and efficacy are warranted. PMID:26446484

Multi-ingredient, caffeine-containing dietary supplements: history, safety, and efficacy.

PubMed

Gurley, Bill J; Steelman, Susan C; Thomas, Sheila L

2015-02-01

Our objective was to review the history, safety, and efficacy of caffeine-containing dietary supplements in the United States and Canada. PubMed and Web of Science databases (1980-2014) were searched for articles related to the pharmacology, toxicology, and efficacy of caffeine-containing dietary supplements with an emphasis on Ephedra-containing supplements, Ephedra-free supplements, and energy drinks or shots. Among the first and most successful dietary supplements to be marketed in the United States were those containing Ephedra—combinations of ephedrine alkaloids, caffeine, and other phytochemicals. A decade after their inception, serious tolerability concerns prompted removal of Ephedra supplements from the US and Canadian markets. Ephedra-free products, however, quickly filled this void. Ephedra-free supplements typically contain multiple caffeine sources in conjunction with other botanical extracts whose purposes can often be puzzling and their pharmacologic properties difficult to predict. Ingestion of these products in the form of tablets, capsules, or other solid dosage forms as weight loss aids, exercise performance enhancers, or energy boosters have once again brought their tolerability and efficacy into question. In addition to Ephedra-free solid dosage forms, caffeine-containing energy drinks have gained a foothold in the world market along with concerns about their tolerability. This review addresses some of the pharmacologic and pharmaceutical issues that distinguish caffeine-containing dietary supplement formulations from traditional caffeine-containing beverages. Such distinctions may account for the increasing tolerability concerns affiliated with these products. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

New drug information resources for pharmacists at the National Library of Medicine.

PubMed

Knoben, James E; Phillips, Steven J

2014-01-01

To provide an overview of selected drug information-related databases of the National Library of Medicine (NLM), with a focus on newer resources that support the professional information needs of pharmacists and other health care providers. NLM, which is the world's largest medical library, provides an array of bibliographic, factual, and evidence-based drug, herbal remedy, and dietary supplement information resources. Five of the more recently introduced online resources include areas of particular importance to pharmacists, including a repository of current product labeling/package inserts, with automated search links to associated information resources; a portal to drug information that allows pharmacists to search multiple databases simultaneously and link to related medication and health care information resources; authoritative information on the effects of medications, herbal remedies, and dietary supplements in nursing infants and their mothers; comprehensive information, including a case registry, on the potential for liver toxicity due to drugs, herbal remedies, and dietary supplements; and a pill identification system with two intuitive search methodologies. NLM provides several clinical-scientific drug information resources that are particularly useful in meeting the professional information needs of pharmacists.

Dietary Supplement Ingredient Database

MedlinePlus

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Prescription Omega-3 Fatty Acid Products and Dietary Supplements Are Not Interchangeable.

PubMed

Hilleman, Daniel; Smer, Aiman

2016-01-01

To provide an overview of prescription and dietary supplement omega-3 fatty acid (OM3-FA) products and considerations for clinical use. Narrative review. The PubMed database was searched for cardiovascular-related investigations focused on eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) (limit: English-only articles). Additional regulatory information on prescription and dietary supplements was obtained from United States Food and Drug Administration online sources. Prescription QM3-FA products are supported by robust clinical development and safety monitoring programs, whereas dietary supplements are not required to demonstrate safety or efficacy prior to marketing. There are no over-the-counter OM3-FA products available in the United States. Investigations of OM3-FA dietary supplements show that quantities of EPA and DHA are highly variable within and between brands. Dietary supplements also may contain potentially harmful components, including oxidized OM3-FA, other lipids, cholesterol, and toxins. Prescription OM3-FA products may contain DHA and EPA or EPA alone. All prescription OM3-FA products have demonstrated statistically significant triglyceride reduction as monotherapy or in combination with statins in patients with hypertriglyceridemia. Differential effects between products containing EPA and DHA compared with a high-purity EPA product (icosapent ethyl) have clinical implications: Increases in low-density lipoprotein cholesterol associated with DHA have the potential to confound strategies for managing patients with dyslipidemia. Cardiovascular outcomes studies of prescription CM3-FA products are ongoing. OM3-FA dietary supplements should not be substituted for prescription products, and prescription OM3-FA products that contain DHA are not equivalent to or interchangeable with high-purity EPA (icosapent ethyl) and should not be substituted for it.

Drug-induced liver injury secondary to testosterone prohormone dietary supplement use.

PubMed

Hoedebecke, Kyle; Rerucha, Caitlyn; Maxwell, Kimberly; Butler, Jason

2013-01-01

Dietary supplementation has become progressively more prevalent, with over half of the American population reporting use of various products. An increased incidence of supplement use has been reported in the military especially within Special Operations Forces (SOF) where training regimens rival those of elite athletes. Federal regulations regarding dietary supplements are minimal, allowing for general advertisement to the public without emphasis on the potentially harmful side effects. Subsequent medical care for these negative effects causes financial burden on the military in addition to the unit?s loss of an Operator and potential mission compromise. This report reviews a case of an Operator diagnosed with drug-induced liver injury secondary to a testosterone prohormone supplement called Post Cycle II. Clinical situations like this emphasize the necessity that SOF Operators and clinicians be aware of the risks and benefits of these minimally studied substances. Providers should also be aware of the Human Performance Resource Center for Health Information and Natural Medicines Comprehensive Database supplement safety ratings as well as the Food and Drug Administration?s MedWatch and Natural Medicines WATCH, to which adverse reactions should be reported. 2013.

Melasma: systematic review of the systemic treatments.

PubMed

Zhou, Linghong Linda; Baibergenova, Akerke

2017-09-01

Currently available treatment options for melasma include prevention of UV radiation, topical lightening agents, chemical peels, and light-based and laser therapies. However, none have shown effective and sustained results, with incomplete clearance and frequent recurrences. There has been increasing interest recently in oral medications and dietary supplements in improving melasma. We sought to evaluate the efficacy and safety/tolerability of oral medications and dietary supplements for the treatment of melasma. Multiple databases were systematically searched for randomized clinical trials (RCTs) evaluating the use of oral medication for treatment of melasma alone or in combination with other treatments. A total of eight RCTs met inclusion criteria. Oral medications and dietary supplements evaluated include tranexamic acid, Polypodium leucotomos extract, beta-carotenoid, melatonin, and procyanidin. These agents appear to have a beneficial effect on melasma improvement. In conclusion, oral medications have a role in melasma treatment and have been shown to be efficacious and tolerable with a minimal number and severity of adverse events. Therefore, dermatologists should keep oral medications and dietary supplements in their armamentarium for the treatment of melasma. © 2017 The International Society of Dermatology.

Women who take n-3 long-chain polyunsaturated fatty acid supplements during pregnancy and lactation meet the recommended intake.

PubMed

Jia, Xiaoming; Pakseresht, Mohammadreza; Wattar, Nour; Wildgrube, Jamie; Sontag, Stephanie; Andrews, Murphy; Subhan, Fatheema Begum; McCargar, Linda; Field, Catherine J

2015-05-01

The aim of the current study was to estimate total intake and dietary sources of eicosapentaenoic acid (EPA), docosapentanoic (DPA), and docosahexaenoic acid (DHA) and compare DHA intakes with the recommended intakes in a cohort of pregnant and lactating women. Twenty-four-hour dietary recalls and supplement intake questionnaires were collected from 600 women in the Alberta Pregnancy Outcomes and Nutrition (APrON) cohort at each trimester of pregnancy and 3 months postpartum. Dietary intake was estimated in 2 ways: by using a commercial software program and by using a database created for APrON. Only 27% of women during pregnancy and 25% at 3 months postpartum met the current European Union (EU) consensus recommendation for DHA. Seafood, fish, and seaweed products contributed to 79% of overall n-3 long-chain polyunsaturated fatty acids intake from foods, with the majority from salmon. The estimated intake of DHA and EPA was similar between databases, but the estimated DPA intake was 20%-30% higher using the comprehensive database built for this study. Women who took a supplement containing DHA were 10.6 and 11.1 times more likely to meet the current EU consensus recommendation for pregnancy (95% confidence interval (CI): 6.952-16.07; P<0.001) and postpartum (95% CI: 6.803-18.14; P<0.001), respectively. Our results suggest that the majority of women in the cohort were not meeting the EU recommendation for DHA during pregnancy and lactation, but taking a supplement significantly improved the likelihood that they would meet recommendations.

Dietary supplements and risk of cause-specific death, cardiovascular disease, and cancer: a protocol for a systematic review and network meta-analysis of primary prevention trials.

PubMed

Schwingshackl, Lukas; Hoffmann, Georg; Buijsse, Brian; Mittag, Tamara; Stelmach-Mardas, Marta; Boeing, Heiner; Gottschald, Marion; Dietrich, Stefan; Arregui, Maria; Dias, Sofia

2015-03-26

In the Western world, dietary supplements are commonly used to prevent chronic diseases, mainly cardiovascular disease and cancer. However, there is inconsistent evidence on which dietary supplements actually lower risk of chronic disease, and some may even increase risk. We aim to evaluate the comparative safety and/or effectiveness of dietary supplements for the prevention of mortality (all-cause, cardiovascular, and cancer) and cardiovascular and cancer incidence in primary prevention trials. We will search PubMed, EMBASE, Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Cochrane Central Register of Controlled Trials, clinical trials.gov, and the World Health Organization International Trial Registry Platform. Randomized controlled trials will be included if they meet the following criteria: (1) minimum intervention period of 12 months; (2) primary prevention of chronic disease (is concerned with preventing the onset of diseases and conditions); (3) minimum mean age ≥18 years (maximum mean age 70 years); (4) intervention(s) include vitamins (beta-carotene, vitamin A, B vitamins, Vitamin C, Vitamin D, Vitamin E, and multivitamin supplements); fatty acids (omega-3 fatty acids, omega-6 fatty acids, monounsaturated fat); minerals (magnesium, calcium, selenium, potassium, iron, zinc, copper, iodine; multiminerals); supplements containing combinations of both vitamins and minerals; protein (amino acids); fiber; prebiotics; probiotics; synbiotics; (5) supplements are orally administered as liquids, pills, capsules, tablets, drops, ampoules, or powder; (6) report results on all-cause mortality (primary outcome) and/or mortality from cardiovascular disease or cancer, cardiovascular and/or cancer incidence (secondary outcomes). Pooled effects across studies will be calculated using Bayesian random effects network meta-analysis. Sensitivity analysis will be performed for trials lasting ≥5 years, trials with low risk of bias, trials in elderly people (≥65 years), ethnicity, geographical region, and trials in men and women. The results of the corresponding fixed effects models will also be compared in sensitivity analyses. This is a presentation of the study protocol only. Results and conclusions are pending completion of this study. Our systematic review will be of great value to consumers of supplements, healthcare providers, and policy-makers, regarding the use of dietary supplements. CRD42014014801 .

Impact of food supplementation on weight loss in randomised-controlled dietary intervention trials: a systematic review and meta-analysis.

PubMed

Wibisono, Cinthya; Probst, Yasmine; Neale, Elizabeth; Tapsell, Linda

2016-04-01

Dietary trials provide evidence for practice and policy guidelines, but poor adherence may confound results. Food supplementation may improve adherence to dietary interventions, but the impact of supplementation on study outcomes is not known. The aim of this review was to examine the impact of food supplementation on weight loss in dietary intervention trials. The databases Scopus, PubMed and the Cochrane Library were searched for dietary intervention trials published between January 2004 and March 2015 using the following keyword combinations: 'trial' OR 'intervention', 'food' OR 'diet', 'weight loss' and 'adherence' OR 'adherence'. Studies were included if food was provided to at least one study group and both 'weight change' and 'adherence' were reported. Random effects meta-analyses were conducted to assess weighted mean differences (WMD) in body weight (change or final mean values). The included studies formed two groups: trials involving an intervention group supplemented with a food and a control without food supplementation (food v. no food), and trials in which food was provided to all subjects (food v. food) (PROSPERO registration: CRD42015017563). In total, sixteen studies were included. Significant weight reduction was reported in the food v. no food studies (WMD -0·74 kg; 95 % CI -1·40, -0·08; P=0·03, I 2=63 %). A non-significant increase in weight was found among the food v. food studies (WMD 0·84 kg; 95 % CI -0·60, 2·27; P=0·25, I 2=0 %). Food supplementation appeared to result in greater weight loss in dietary trials. Energy restrictions and intensity of interventions were other significant factors influencing weight loss.

Challenges of conducting clinical trials of natural products to combat cancer.

PubMed

Paller, Channing J; Denmeade, Samuel R; Carducci, Michael A

2016-06-01

Numerous drugs that the US Food and Drug Administration (FDA) has approved for use in cancer therapy are derived from plants, including taxanes such as paclitaxel and vinca alkaloids such as vinblastine. Dietary supplements are another category of natural products that are widely used by patients with cancer, but without the FDA-reviewed evidence of safety and efficacy--be it related to survival, palliation, symptom mitigation, and/or immune system enhancement-that is required for therapy approval. Nearly half of patients in the United States with cancer report that they started taking new dietary supplements after being given a diagnosis of cancer. Oncologists are challenged in providing advice to patients about which supplements are safe and effective to use to treat cancer or the side effects of cancer therapy, and which supplements are antagonistic to standard treatment with chemotherapy, radiation, and/or immunotherapy. Despite the large number of trials that have been launched, the FDA has not approved any dietary supplement or food to prevent cancer, halt its growth, or prevent its recurrence. In this article, we review the primary challenges faced by researchers attempting to conduct rigorous trials of natural products, including shortages of funding due to lack of patentability, manufacturing difficulties, contamination, and lack of product consistency. We also highlight the methods used by dietary supplement marketers to persuade patients that a supplement is effective (or at least safe) even without FDA approval, as well as the efforts of the US government to protect the health and safety of its citizens by ensuring that the information used to market natural products is accurate. We close with a summary of the most widely used databases of information about the safety, efficacy, and interactions of dietary supplements.

Certification of elements in and use of standard reference material 3280 multivitamin/multielement tablets.

PubMed

Turk, Gregory C; Sharpless, Katherine E; Cleveland, Danielle; Jongsma, Candice; Mackey, Elizabeth A; Marlow, Anthony F; Oflaz, Rabia; Paul, Rick L; Sieber, John R; Thompson, Robert Q; Wood, Laura J; Yu, Lee L; Zeisler, Rolf; Wise, Stephen A; Yen, James H; Christopher, Steven J; Day, Russell D; Long, Stephen E; Greene, Ella; Harnly, James; Ho, I-Pin; Betz, Joseph M

2013-01-01

Standard Reference Material 3280 Multivitamin/ Multielement Tablets was issued by the National Institute of Standards and Technology in 2009, and has certified and reference mass fraction values for 13 vitamins, 26 elements, and two carotenoids. Elements were measured using two or more analytical methods at NIST with additional data contributed by collaborating laboratories. This reference material is expected to serve a dual purpose: to provide quality assurance in support of a database of dietary supplement products and to provide a means for analysts, dietary supplement manufacturers, and researchers to assess the appropriateness and validity of their analytical methods and the accuracy of their results.

Breast cancer and dietary factors in Taiwanese women.

PubMed

Lee, Marion M; Chang, Ilona Yuan Hui; Horng, Cheng Fang; Chang, Jeffrey S; Cheng, Skye Hongiun; Huang, Andrew

2005-10-01

To examine the effect of the consumption of dietary factors on the risk of breast cancer in a case-control study in Taiwan. Two-hundred-and-fifty cases and 219 age-matched controls between the ages of 25 and 74 were interviewed in person between 1996 and 1999. Usual consumption of dietary habits including 100 foods was assessed using a food frequency questionnaire and a nutrient database developed and validated in Taiwanese populations. Cases consumed significantly more fat than controls. Cases also consumed statistically significant less supplements such as vitamins and mineral than controls. Food group analyses showed that highest quartile of beef and pork intake significantly increased risk in younger women (OR = 2.5, 95% CI = 1.0-6.0) and all women (OR = 2.5, 95% CI = 1.1-3.3). The age- education- and total calorie-adjusted odds ratio (OR) of breast cancer risk comparing the highest and second highest quartile of fat intake to the lowest quartile was 5.1, 95% confidence interval (CI): 2.1-13 and 3.5, 95% CI: 1.4-8.7 among those younger cases (< or =40). A multiple regression model indicates a protective effect of supplements (OR: 0.40, 95% CI: 0.3-07) and a harmful effect of dietary fat (OR: 2.6, 95% CI: 1.4-5.0) for the highest versus lowest quartile in all women. Our results indicate a strong protective effect of dietary supplements and a harmful effect of dietary fats on the risk of breast cancer among women in Taiwan. These findings should be confirmed in future follow-up studies. Specific amount of dietary supplements and dietary fats should be quantified for a more accurate evaluation on the risk for breast cancer in this population.

Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review.

PubMed

Kanji, Salmaan; Seely, Dugald; Yazdi, Fatemeh; Tetzlaff, Jennifer; Singh, Kavita; Tsertsvadze, Alexander; Tricco, Andrea C; Sears, Margaret E; Ooi, Teik C; Turek, Michele A; Skidmore, Becky; Ansari, Mohammed T

2012-05-31

The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed.Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s) with the drug(s) alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets) and garlic (plus nitrates or warfarin) on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

The effect of dietary supplements on clinical aspects of autism spectrum disorder: A systematic review of the literature.

PubMed

Gogou, Maria; Kolios, George

2017-09-01

Autism spectrum disorder is associated with significant social and financial burden and no definite treatment for this entity has been identified, yet. In recent years there has been an increasing interest in the use of dietary interventions as a complementary therapeutic option for these patients. The aim of this systematic review is to provide high evidence level literature data about the effect of dietary supplements on clinical aspects of children with autism. A comprehensive literature search was conducted using Pubmed as the medical database source. Randomized controlled trials conducted in pediatric populations and including measures of clinical outcomes were considered. A total of 17 eligible prospective studies were selected. Types of dietary supplements evaluated in these studies included amino acids, fatty acids and vitamins/minerals. N-acetylcysteine was shown to exert a beneficial effect on symptoms of irritability. On the other hand, literature data about the efficacy of d-cycloserine and pyridoxine-magnesium supplements was controversial. No significant effect was identified for fatty acids, N,N-dimethylglycine and inositol. Literature data about ascorbic acid and methyl B12 was few, although some encouraging results were found. No serious adverse events were reported in the vast majority of the studies, while the prevalence of adverse reactions was similar between treatment and placebo groups. The use of dietary supplements in children with autism seems to be a safe practice with encouraging data about their clinical efficacy. More studies are needed to further investigate this issue. Copyright © 2017 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

Phosphorus Balance in Adolescent Girls and the Effect of Supplemental Dietary Calcium.

PubMed

Vorland, Colby J; Martin, Berdine R; Weaver, Connie M; Peacock, Munro; Gallant, Kathleen M Hill

2018-03-01

There are limited data on phosphorus balance and the effect of dietary calcium supplements on phosphorus balance in adolescents. The purpose of this study was to determine phosphorus balance and the effect of increasing dietary calcium intake with a supplement on net phosphorus absorption and balance in healthy adolescent girls. This study utilized stored urine, fecal, and diet samples from a previously conducted study that focused on calcium balance. Eleven healthy girls ages 11 to 14 years participated in a randomized crossover study, which consisted of two 3-week periods of a controlled diet with low (817 ± 19.5 mg/d) or high (1418 ± 11.1 mg/d) calcium, separated by a 1-week washout period. Phosphorus intake was controlled at the same level during both placebo and calcium supplementation (1435 ± 23.5 and 1453 ± 28.0 mg/d, respectively, p = 0.611). Mean phosphorus balance was positive by about 200 mg/d and was unaffected by the calcium supplement ( p = 0.826). Urinary phosphorus excretion was lower with the calcium supplement (535 ± 42 versus 649 ± 41 mg/d, p = 0.013), but fecal phosphorus and net phosphorus absorption were not significantly different between placebo and calcium supplement (553 ± 60 versus 678 ± 63 versus mg/d, p = 0.143; 876 ± 62 versus 774 ± 64 mg/d, p = 0.231, respectively). Dietary phosphorus underestimates using a nutrient database compared with the content measured chemically from meal composites by ~40%. These results show that phosphorus balance is positive in girls during adolescent growth and that a calcium dietary supplement to near the current recommended level does not affect phosphorus balance when phosphorus intake is at 1400 mg/d, a typical US intake level. © 2017 American Society for Bone and Mineral Research.

Role of supplemental calcium in the recurrence of colorectal adenomas: a metaanalysis of randomized controlled trials.

PubMed

Shaukat, Aasma; Scouras, Nicole; Schünemann, Holger J

2005-02-01

Colorectal adenomas are neoplastic growths that are important targets for chemoprevention. Dietary calcium is thought to play an important role in chemoprevention. However, the role of calcium supplementation for preventing recurrence of adenomas is controversial. We performed a systematic review and meta-analysis to study the role of calcium supplementation in preventing recurrence of adenomas. We searched electronic bibliographic databases (Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, CINAHL, EMBASE, and MEDLINE) and contacted authors to identify potentially eligible studies. We identified three trials including 1,485 subjects with previously removed adenomas who were randomized to calcium versus placebo supplementation. The study endpoint was recurrence of adenomas at the end of 3-4 yr in 1,279 patients who completed the trials. We found that the recurrence of adenomas was significantly lower in subjects randomized to calcium supplementation (RR: 0.80, CI: 0.68, 0.93; p-value = 0.004). This systematic review and meta-analysis suggest that calcium supplementation prevents recurrent colorectal adenomas.

USDA food and nutrient databases provide the infrastructure for food and nutrition research, policy, and practice.

PubMed

Ahuja, Jaspreet K C; Moshfegh, Alanna J; Holden, Joanne M; Harris, Ellen

2013-02-01

The USDA food and nutrient databases provide the basic infrastructure for food and nutrition research, nutrition monitoring, policy, and dietary practice. They have had a long history that goes back to 1892 and are unique, as they are the only databases available in the public domain that perform these functions. There are 4 major food and nutrient databases released by the Beltsville Human Nutrition Research Center (BHNRC), part of the USDA's Agricultural Research Service. These include the USDA National Nutrient Database for Standard Reference, the Dietary Supplement Ingredient Database, the Food and Nutrient Database for Dietary Studies, and the USDA Food Patterns Equivalents Database. The users of the databases are diverse and include federal agencies, the food industry, health professionals, restaurants, software application developers, academia and research organizations, international organizations, and foreign governments, among others. Many of these users have partnered with BHNRC to leverage funds and/or scientific expertise to work toward common goals. The use of the databases has increased tremendously in the past few years, especially the breadth of uses. These new uses of the data are bound to increase with the increased availability of technology and public health emphasis on diet-related measures such as sodium and energy reduction. Hence, continued improvement of the databases is important, so that they can better address these challenges and provide reliable and accurate data.

An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series.

PubMed

Brown, Amy Christine

2017-09-01

This is the first of five review articles investigating dietary supplements (DS; includes herbs) that now exceed over 50,000 in the Office of Dietary Supplement's "Dietary Supplement Label Database." Four review articles follow summarizing published medical case reports of DS related to liver toxicity, kidney toxicity, heart toxicity, and cancer. The most popular DS were vitamin or mineral supplements (43%) followed by specialty supplements (20%), botanicals (20%; herbs), and sports supplements (16%). The 2013 Annual Report of the American Association of Poison Control Centers revealed 1692 fatalities due to drugs, and zero deaths due to DS. Less than 1 percent of Americans experience adverse events related to DS, and the majority was classified as minor, with many of these related to caffeine, yohimbe, or other stimulant ingredients. The number one adulterant in DS is drugs, followed by New Dietary Ingredients (NDI) not submitted to the FDA - both are illegal and not DS, but rather "tainted products marketed as dietary supplements." The three main categories of DS prone to medical problems are those for sexual enhancement, weight loss, and sports performance/body building. DS are regulated in the U.S. by several federal agencies with overlapping jurisdiction - the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); enforced by the State Attorneys General Offices (AGO) and Department of Justice (DOJ); and monitored (not regulated) by the Centers for Disease Control and Prevention (CDC). The FDA can remove a DS from the market for phase IV post-marketing surveillance adverse event reports, adulteration (drugs, NDI, synthetic substances), contamination, misidentification, mislabeling or false claims, and not meeting good manufacturing practices (GMP). The FTC and state AGO can also enforce laws against deceptive marketing practices. Suggested improvements to current regulatory requirements are included along with online DS Toxic Tables in the series to forewarn consumers, clinicians, corporations, and governments of possible serious adverse events. They may also quicken the response rate during Phase IV post-marketing surveillance, in which governments could then exercise their regulatory powers. Copyright © 2017 Elsevier Ltd. All rights reserved.

The role of diet and nutritional supplementation in perinatal depression: a systematic review.

PubMed

Sparling, Thalia M; Henschke, Nicholas; Nesbitt, Robin C; Gabrysch, Sabine

2017-01-01

This article presents a systematic literature review on whether dietary intake influences the risk for perinatal depression, i.e. depression during pregnancy or post-partum. Such a link has been hypothesized given that certain nutrients are important in the neurotransmission system and pregnancy depletes essential nutrients. PubMed, EMBASE and CINAHL databases were searched for relevant articles until 30 May 2015. We included peer-reviewed studies of any design that evaluated whether perinatal depression is related to dietary intake, which was defined as adherence to certain diets, food-derived intake of essential nutrients or supplements. We identified 4808 studies, of which 35 fulfilled inclusion criteria: six randomized controlled trials, 12 cohort, one case-control and 16 cross-sectional studies, representing 88 051 distinct subjects. Studies were grouped into four main categories based on the analysis of dietary intake: adherence to dietary patterns (nine studies); full panel of essential nutrients (six studies); specific nutrients (including B vitamins, Vitamin D, calcium and zinc; eight studies); and intake of fish or polyunsaturated fatty acids (PUFAs; 12 studies). While 13 studies, including three PUFA supplementation trials, found no evidence of an association, 22 studies showed protective effects from healthy dietary patterns, multivitamin supplementation, fish and PUFA intake, calcium, Vitamin D, zinc and possibly selenium. Given the methodological limitations of existing studies and inconsistencies in findings across studies, the evidence on whether nutritional factors influence the risk of perinatal depression is still inconclusive. Further longitudinal studies are needed, with robust and consistent measurement of dietary intake and depressive symptoms, ideally starting before pregnancy. © 2016 John Wiley & Sons Ltd.

Dietary supplements and prostate cancer: a systematic review of double-blind, placebo-controlled randomised clinical trials.

PubMed

Posadzki, Paul; Lee, Myeong Soo; Onakpoya, Igho; Lee, Hye Won; Ko, Byong Seob; Ernst, Edzard

2013-06-01

Dietary supplements are popular among patients with prostate cancer (PC). The objective of this systematic review was to critically examine double-blind, placebo-controlled randomised clinical trials (RCTs) of non-herbal dietary supplements and vitamins (NHDS) for evidence that prostate specific antigen (PSA) levels were reduced in PC patients. Five databases were searched from their inception through December 2012 to identify studies that met our inclusion criteria. Methodological quality was independently assessed by two reviewers using the Cochrane tool. Eight RCTs met the eligibility criteria and were of high methodological quality. The following supplements were tested: isoflavones (genistein, daidzein, and glycitein), minerals (Se) or vitamins (vitamin D) or a combination of antioxidants, bioflavonoids, carotenoids, lycopenes, minerals (Se, Zn, Cu, and Mg), phytoestrogens, phytosterols, vitamins (B2, B6, B9, B12, C, and E), and other substances (CoQ10 and n-acetyl-l cysteine). Five RCTs reported no significant effects compared with placebo. Two RCTs reported that a combination of antioxidants, isoflavones, lycopenes, minerals, plant oestrogens and vitamins significantly decreased PSA levels compared with placebo. One RCT did not report differences in PSA levels between the groups. In conclusion, the hypothesis that dietary supplements are effective treatments for PC patients is not supported by sound clinical evidence. There are promising data for only two specific remedies, which contained a mixture of ingredients, but even for these supplements, additional high quality evidence is necessary before firm recommendations would be justified. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Nutritional and Dietary Interventions for Autism Spectrum Disorder: A Systematic Review.

PubMed

Sathe, Nila; Andrews, Jeffrey C; McPheeters, Melissa L; Warren, Zachary E

2017-06-01

Children with autism spectrum disorder (ASD) frequently use special diets or receive nutritional supplements to treat ASD symptoms. Our objective was to evaluate the effectiveness and safety of dietary interventions or nutritional supplements in ASD. Databases, including Medline and PsycINFO. Two investigators independently screened studies against predetermined criteria. One investigator extracted data with review by a second investigator. Investigators independently assessed the risk of bias and strength of evidence (SOE) (ie, confidence in the estimate of effects). Nineteen randomized controlled trials (RCTs), 4 with a low risk of bias, evaluated supplements or variations of the gluten/casein-free diet and other dietary approaches. Populations, interventions, and outcomes varied. Ω-3 supplementation did not affect challenging behaviors and was associated with minimal harms (low SOE). Two RCTs of different digestive enzymes reported mixed effects on symptom severity (insufficient SOE). Studies of other supplements (methyl B 12 , levocarnitine) reported some improvements in symptom severity (insufficient SOE). Studies evaluating gluten/casein-free diets reported some parent-rated improvements in communication and challenging behaviors; however, data were inadequate to make conclusions about the body of evidence (insufficient SOE). Studies of gluten- or casein-containing challenge foods reported no effects on behavior or gastrointestinal symptoms with challenge foods (insufficient SOE); 1 RCT reported no effects of camel's milk on ASD severity (insufficient SOE). Harms were disparate. Studies were small and short-term, and there were few fully categorized populations or concomitant interventions. There is little evidence to support the use of nutritional supplements or dietary therapies for children with ASD. Copyright © 2017 by the American Academy of Pediatrics.

Role of dietary modification in alleviating chronic fatigue syndrome symptoms: a systematic review.

PubMed

Jones, Kathryn; Probst, Yasmine

2017-08-01

To review the evidence for the role of dietary modifications in alleviating chronic fatigue syndrome symptoms. A systematic literature review was guided by PRISMA and conducted using Scopus, CINAHL Plus, Web of Science and PsycINFO scientific databases (1994-2016) to identify relevant studies. Twenty-two studies met the inclusion criteria, the quality of each paper was assessed and data extracted into a standardised tabular format. Positive outcomes were highlighted in some included studies for polyphenol intakes in animal studies, D-ribose supplementation in humans and aspects of symptom alleviation for one of three polynutrient supplement studies. Omega three fatty acid blood levels and supplementation with an omega three fatty acid supplement also displayed positive outcomes in relation to chronic fatigue syndrome symptom alleviation. Limited dietary modifications were found useful in alleviating chronic fatigue syndrome symptoms, with overall evidence narrow and inconsistent across studies. Implications for public health: Due to the individual and community impairment chronic fatigue syndrome causes the population, it is vital that awareness and further focused research on this topic is undertaken to clarify and consolidate recommendations and ensure accurate, useful distribution of information at a population level. © 2017 The Authors.

Vitamin C and survival among women with breast cancer: a meta-analysis.

PubMed

Harris, Holly R; Orsini, Nicola; Wolk, Alicja

2014-05-01

The association between dietary vitamin C intake and breast cancer survival is inconsistent and few studies have specifically examined vitamin C supplement use among women with breast cancer. The purpose of this study was to summarise results from prospective studies on the association between vitamin C supplement use and dietary vitamin C intake and breast cancer-specific mortality and total mortality. Studies were identified using the PubMed database through February 6, 2014 and by examining the references of retrieved articles. Prospective studies were included if they reported relative risks (RR) with 95% confidence intervals (95% CIs) for at least two categories or as a continuous exposure. Random-effects models were used to combine study-specific results. The ten identified studies examined vitamin C supplement use (n=6) and dietary vitamin C intake (n=7) and included 17,696 breast cancer cases, 2791 total deaths, and 1558 breast cancer-specific deaths. The summary RR (95% CI) for post-diagnosis vitamin C supplement use was 0.81 (95% CI 0.72-0.91) for total mortality and 0.85 (95% CI 0.74-0.99) for breast cancer-specific mortality. The summary RR for a 100mg per day increase in dietary vitamin C intake was 0.73 (95% CI 0.59-0.89) for total mortality and 0.78 (95% CI 0.64-0.94) for breast cancer-specific mortality. Results from this meta-analysis suggest that post-diagnosis vitamin C supplement use may be associated with a reduced risk of mortality. Dietary vitamin C intake was also statistically significantly associated with a reduced risk of total mortality and breast cancer-specific mortality. Copyright © 2014 Elsevier Ltd. All rights reserved.

Consumption and reasons for use of dietary supplements in an Australian university population.

PubMed

Barnes, Katelyn; Ball, Lauren; Desbrow, Ben; Alsharairi, Naser; Ahmed, Faruk

2016-05-01

The aim of this study was to examine the association between dietary supplement use and sociodemographic factors in an Australian university population. Additionally, reasons for use of specific dietary supplements were explored. A cross-sectional online questionnaire was completed by 1633 students and staff members of Griffith University, Queensland, Australia (76% female). The questionnaire collected information on sociodemographic characteristics, use of dietary supplements, and reasons for use of each dietary supplement reported. Multiple regression analyses were used to describe the relationship between demographic factors and dietary supplement use. Pearson χ(2) was used to identify correlations between frequency of dietary supplement use and selected demographic factors. Frequency distributions were used to explore the reasons for use of each dietary supplement reported. Vitamin or mineral use and use of "other" dietary supplements was reported by 69% and 63% of participants, respectively. Age, sex, ethnicity, and physical activity were independently associated with dietary supplement use. Age, sex, and income were associated with acute use of specific dietary supplements during illness or injury. The reasons for use of specific dietary supplements were closely aligned with marketed claims. Broad reasons of health were commonly reported for use of most dietary supplements. Use of dietary supplements in this population reflects that of other countries. Individuals were unsure of the benefits and risks associated with dietary supplementation. Health professionals should account for dietary supplements when assessing diet. These results also warrant consideration by regulating bodies and public health officers to ensure safe practices. Copyright © 2016 Elsevier Inc. All rights reserved.

The use of, and perceptions about, dietary supplements among patients with heart failure.

PubMed

Fan, Xiuzhen; Lee, Kyoung Suk; Frazier, Susan K; Lennie, Terry A; Moser, Debra K

2014-08-01

Dietary supplement use is widespread; patterns of use and perceptions about supplements in individuals with heart failure (HF) are not well understood. The purpose of this study was to describe the prevalence, patterns and reasons for use of dietary supplements, and to compare characteristics of, and perceptions about, safety and efficacy between dietary supplement user and non-user participants with HF. Patients with HF (n=99) completed a Dietary Supplement Questionnaire. Descriptive statistics were used to analyze the data. Independent sample t-tests, Fisher's exact test, and Chi square analyses compared dietary supplement users to non-users. More than half of the participants used at least one dietary supplement and almost all patients using dietary supplements reported they had informed their healthcare provider. Dietary supplements were taken to improve intake of dietary components and better individual health state. Participants thought that dietary supplements in general were safer and more effective than current evidence suggests. Users and non-users expressed similar perceptions. Patients who used dietary supplements were older (64±10 years vs 53±12 years) and had a lower body mass index (30.0±6.5 kg/m(2) vs 34.1±8.3 kg/m(2)) compared with patients who did not. Dietary supplement use was common in these participants with HF; global perceptions about safety and efficacy of dietary supplements were similar between users and non-users of dietary supplements. Systematic evaluation of dietary supplement use, with discussion about safety and efficacy may be constructive for patients with HF. © The European Society of Cardiology 2013.

76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related...; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,'' that... Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false When may a returned dietary supplement be salvaged..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.520 When may a returned dietary supplement be salvaged? You may salvage a returned dietary supplement only...

Evaluation of Point-of-Care Resources for Dietary Supplement Information.

PubMed

Montgomery, Ashley E; Beckett, Robert D; Montagano, Kaitlin J; Kutom, Samah

2018-01-01

To evaluate 6 tertiary, point-of-care drug information resources' dietary supplement content. This was a cross-sectional evaluation of Lexicomp Natural Products Database, Micromedex Alternative Medicine, Clinical Pharmacology, Natural Medicines, The Review of Natural Products, and Handbook of Nonprescription Drugs. Each resource was evaluated for scope, completeness, consistency, and ease of use. For a sample of 66 supplements, scope scores ranged from 69.7% (Micromedex) to 100% (Natural Medicines). Completeness scores were high considering uses, dose, adverse effects, and mechanism (85.7% to 100%). Overall completeness scores ranged from 82.5% ( Handbook of Nonprescription Drugs) to 100% (Clinical Pharmacology, Natural Medicines, The Review of Natural Products). Consistency scores ranged from 0% ( Handbook of Nonprescription Drugs) to 100% (Natural Medicines, The Review of Natural Products). Mean time to locate and gather information was similar among groups. Resources were similar for completeness and ease of use. Scope and consistency varied depending on the resource.

A long term feed supplementation based on phosphate binders in Feline Chronic Kidney Disease.

PubMed

Biasibetti, E; Martello, E; Bigliati, M; Biasato, I; Cocca, T; Bruni, N; Capucchio, M T

2018-06-01

Chronic kidney disease (CKD) is a very common disorder in elderly cats. A proper renal diet represents the most efficient therapeutic intervention to improve survival and life quality in feline patients with 3 and 4 International Renal Interest Society (IRIS) stages. Twenty cats were selected in this study. Ten were administered the dietary supplementation for 360 days and the other ten, whose owners did not give consent for any supplemental therapies apart from the renal diet, were selected from a clinical database and used as control group. The present study is a long term study (360 days) aiming to evaluate the efficacy and palatability of a dietary supplementation containing calcium carbonate, calcium-lactate gluconate, chitosan and sodium bicarbonate in cats diagnosed with 3 and 4 IRIS stages of CKD. The owners were asked to fill in questionnaires to get information on the cat's appetite, the palatability of the given supplement, the presence of vomit and/or diarrhoea, general health and vitality. Hematochemical, biochemical and urinary analyses were performed on day 0, 30, 60, 90, 120, 150,180 and 360. GraphPad Prism® software was used to perform statistical analysis. Our study shows that the given dietary supplement reduced serum phosphorus and increased serum bicarbonate values in cats with CKD. In turn, this supplement could be used as a support therapy in cats with advanced CKD improving their clinical conditions without any adverse reaction. Finally, it is important to underline that all the animals completed the study and the owners reported a good palatability of the feed supplement.

Profiling the Use of Dietary Supplements by Brazilian Physical Education Professionals.

PubMed

Viana, Ricardo Borges; Silva, Maria Sebastiana; da Silva, Wellington Fernando; Campos, Mário Hebling; Andrade, Marília Dos Santos; Vancini, Rodrigo Luiz; Andre Barbosa de Lira, Claudio

2018-11-02

A survey was designed to examine the use of dietary supplements by Brazilian physical education professionals. The study included 131 Brazilian physical education professionals (83 men and 48 women). A descriptive statistical analysis was performed (mean, standard deviation, and absolute and relative frequencies). A chi-square test was applied to evaluate differences in use of dietary supplements according to particular variables of interest (p < .05). Forty-nine percent of respondents used dietary supplements. Approximately 59% of dietary supplement users took two or more kinds of supplements. Among users of supplements, men professionals (73%) consumed more dietary supplements than women (27%). The most-consumed dietary supplement was whey protein (80%). The results showed a higher use of dietary supplements by men. The most-consumed supplements were rich in protein. The consumption of dietary supplements by almost half of the participants in this study suggests that participants did not consider their dietary needs to be met by normal diet alone.

Development of Databases with Iodine in Foods and Dietary Supplements

USDA-ARS?s Scientific Manuscript database

Iodine is an essential micronutrient required for normal growth and development, thus an adequate intake of iodine is particularly important in pregnant and lactating women, and throughout childhood. Low levels of iodine in the soil and groundwater are common in many parts of the world, often leadi...

Dietary Supplement Use, Knowledge, and Perceptions Among Student Pharmacists.

PubMed

Axon, David R; Vanova, Janka; Edel, Courtney; Slack, Marion

2017-06-01

Objective. To compare dietary supplement use between student pharmacists and the general population, and assess knowledge, attitudes toward use, and dietary supplement effectiveness; and to explore how student pharmacists view their education on dietary supplements. Methods. Paper questionnaires administered to student pharmacists collected data about their use, knowledge, and attitudes of dietary supplements. Use was compared to the 2007 National Health Interview survey findings. Results. Of 179 students who responded, 52% had used at least one dietary supplement in their lifetime versus 25% in the general population. Students perceived supplement label information as unhelpful, research into supplements inadequate, and supplements non-essential to health. Students thought supplement knowledge was important but their education was inadequate. Conclusion. Dietary supplement use was higher in this sample of student pharmacists than the general population. Student pharmacists had limited knowledge and need more education on dietary supplements.

Dietary Supplement Use, Knowledge, and Perceptions Among Student Pharmacists

PubMed Central

Vanova, Janka; Edel, Courtney; Slack, Marion

2017-01-01

Objective. To compare dietary supplement use between student pharmacists and the general population, and assess knowledge, attitudes toward use, and dietary supplement effectiveness; and to explore how student pharmacists view their education on dietary supplements. Methods. Paper questionnaires administered to student pharmacists collected data about their use, knowledge, and attitudes of dietary supplements. Use was compared to the 2007 National Health Interview survey findings. Results. Of 179 students who responded, 52% had used at least one dietary supplement in their lifetime versus 25% in the general population. Students perceived supplement label information as unhelpful, research into supplements inadequate, and supplements non-essential to health. Students thought supplement knowledge was important but their education was inadequate. Conclusion. Dietary supplement use was higher in this sample of student pharmacists than the general population. Student pharmacists had limited knowledge and need more education on dietary supplements. PMID:28720920

Concomitant use of dietary supplements and medicines in patients due to miscommunication with physicians in Japan.

PubMed

Chiba, Tsuyoshi; Sato, Yoko; Suzuki, Sachina; Umegaki, Keizo

2015-04-16

We previously reported that some patients used dietary supplements with their medication without consulting with physicians. Dietary supplements and medicines may interact with each other when used concomitantly, resulting in health problems. An Internet survey was conducted on 2109 people who concomitantly took dietary supplements and medicines in order to address dietary supplement usage in people who regularly take medicines in Japan. A total of 1508 patients (two admitted patients and 1506 ambulatory patients) and 601 non-patients, who were not consulting with physicians, participated in this study. Purpose for dietary supplement use was different among ages. Dietary supplements were used to treat diseases in 4.0% of non-patients and 11.9% of patients, while 10.8% of patients used dietary supplements to treat the same diseases as their medication. However, 70.3% of patients did not declare dietary supplement use to their physicians or pharmacists because they considered the concomitant use of dietary supplements and medicines to be safe. A total of 8.4% of all subjects realized the potential for adverse effects associated with dietary supplements. The incidence of adverse events was higher in patients who used dietary supplements to treat their disease. Communication between patients and physicians is important for avoiding the adverse effects associated with the concomitant use of dietary supplements and medicines.

Concomitant Use of Dietary Supplements and Medicines in Patients due to Miscommunication with Physicians in Japan

PubMed Central

Chiba, Tsuyoshi; Sato, Yoko; Suzuki, Sachina; Umegaki, Keizo

2015-01-01

We previously reported that some patients used dietary supplements with their medication without consulting with physicians. Dietary supplements and medicines may interact with each other when used concomitantly, resulting in health problems. An Internet survey was conducted on 2109 people who concomitantly took dietary supplements and medicines in order to address dietary supplement usage in people who regularly take medicines in Japan. A total of 1508 patients (two admitted patients and 1506 ambulatory patients) and 601 non-patients, who were not consulting with physicians, participated in this study. Purpose for dietary supplement use was different among ages. Dietary supplements were used to treat diseases in 4.0% of non-patients and 11.9% of patients, while 10.8% of patients used dietary supplements to treat the same diseases as their medication. However, 70.3% of patients did not declare dietary supplement use to their physicians or pharmacists because they considered the concomitant use of dietary supplements and medicines to be safe. A total of 8.4% of all subjects realized the potential for adverse effects associated with dietary supplements. The incidence of adverse events was higher in patients who used dietary supplements to treat their disease. Communication between patients and physicians is important for avoiding the adverse effects associated with the concomitant use of dietary supplements and medicines. PMID:25894658

76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.470 What requirements apply to distributing dietary supplements? You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration. ...

77 FR 50699 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and.... Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and... reporting for dietary supplements and nonprescription drugs marketed without an approved application. The...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Dietary supplements containing ephedrine alkaloids... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK § 119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing...

Arginine for gestating sows and foetal development: A systematic review.

PubMed

Palencia, J Y P; Lemes, M A G; Garbossa, C A P; Abreu, M L T; Pereira, L J; Zangeronimo, M G

2018-02-01

The use of functional amino acids during pregnancy has been linked to improved reproduction in mammals. In this context, arginine is a precursor in the synthesis of numerous molecules, such as nitric oxide and polyamines, which play an important role during reproduction. However, contradictory studies are found in the literature, particularly regarding the amount of supplementation and the period of pregnancy in which it is used. The objective of this study was to evaluate the effects of dietary arginine supplementation for pregnant sows on foetal development via a systematic review. The search for papers was performed during the month of December 2015, in the databases ISI Web of Science, Science Direct, Scopus, and SciELO. From a total of 5675 returned studies, only 13 papers were selected after applying selection criteria. Most (47%) of the studies that evaluated the effects of dietary arginine supplementation on foetal development in pigs used 1% arginine. Supplementation was initiated in the first third of pregnancy in 47% of tests, including in both primiparous and multiparous sows. These studies showed positive results for embryo survival and foetal development, evidenced by the increase in placental weight and the number and weight of piglets born alive. Of all evaluated studies, 53% showed benefits on foetal development. It is concluded that supplementing dietary arginine in gestating sows can benefit embryo survival and foetal development. However, to establish a supplementation plan with this amino acid, aspects related to the period of pregnancy, supplementation levels, and source of arginine must be well defined. © 2017 Blackwell Verlag GmbH.

Comparison of a Medication Inventory and a Dietary Supplement Interview in Assessing Dietary Supplement Use in the Hispanic Community Health Study/Study of Latinos

PubMed Central

Faurot, Keturah R.; Siega-Riz, Anna Maria; Gardiner, Paula; Rivera, José O.; Young, Laura A.; Poole, Charles; Whitsel, Eric A.; González, Hector M.; Chirinos-Medina, Diana A.; Talavera, Gregory A.; Castañeda, Sheila F.; Daviglus, Martha L.; Barnhart, Janice; Giacinto, Rebeca E.; Van Horn, Linda

2016-01-01

Although dietary supplement use is common, its assessment is challenging, especially among ethnic minority populations such as Hispanics/Latinos. Using the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) (n = 16,415), this report compares two strategies for capturing dietary supplement use over a 30-day period: a medication-based inventory and a nutrition-based dietary supplement interview. Age-standardized prevalence was calculated across multiple dietary supplement definitions, adjusted with survey/nonresponse weights. The prevalence of dietary supplement use was substantially higher as measured in the dietary supplement interview, compared to the medication inventory: for total dietary supplements (39% vs 26%, respectively), for nonvitamin, nonmineral supplements (24% vs 12%), and for botanicals (9.2% vs 4.5%). Concordance between the two assessments was fair to moderate (Cohen’s kappa: 0.31–0.52). Among women, inclusion of botanical teas increased the prevalence of botanical supplement use from 7% to 15%. Supplement assessment that includes queries about botanical teas yields more information about patient supplement use. PMID:26917949

Use of dietary supplements among people living with HIV/AIDS is associated with vulnerability to medical misinformation on the internet

PubMed Central

2012-01-01

Background Use of dietary supplements is common among people living with HIV/AIDS. Because dietary supplements are used in the context of other health behaviors, they may have direct and indirect health benefits. However, supplements may also be associated with vulnerability to medical misinformation and unfounded health claims. We examined use of dietary supplements among people living with HIV/AIDS (PLWH) and the association between use of dietary supplements and believing medical misinformation. Methods A convenience sample of 268 men and 76 women living with HIV was recruited from AIDS services and clinics in Atlanta, GA. Participants completed measures of demographic and health characteristics, dietary supplement use, beliefs about dietary supplements, internet use, and an internet evaluation task designed to assess vulnerability to medical misinformation. Results One out of four PLWH currently used at least one dietary supplement product excluding vitamins. Dietary supplement use was associated with higher education and greater use of the internet for health-related information. Dietary supplement users also endorsed greater believability and trust in unfounded claims for HIV cures. Conclusions Dietary supplement use is common among PLWH and is associated with a broad array of health information seeking behaviors. Interventions are needed to reduce the vulnerability of PLWH, particularly dietary supplement users, to medical misinformation propagated on the internet. PMID:22233928

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

Time To Talk About Dietary Supplements: 5 Things Consumers Need To Know

MedlinePlus

... 5 Tips: What Consumers Need To Know About Dietary Supplements Share: Many people take dietary supplements in an effort to be well and stay ... also called “natural products,” are one type of dietary supplement. Dietary supplements can come in the form of ...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.510 What requirements apply when a returned dietary supplement is received? You must identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a...

Safe Use of Complementary Health Products and Practices

MedlinePlus

... Mind and Body Practices for Children and Teens Dietary Supplement Safety Information Using Dietary Supplements Wisely Dietary Supplement ... Homeopathic Drugs Dietary Supplements—Adverse Event Reporting ( FDA ) Dietary Supplement Alerts and Advisories Alerts and Advisories Clinical Practice ...

Definitions of Health Terms: Minerals

MedlinePlus

... National Institutes of Health, Office of Dietary Supplements Dietary Supplements A dietary supplement is a product you take to supplement your ... safety. Source : National Institutes of Health, Office of Dietary Supplements Electrolytes Electrolytes are minerals in body fluids. They ...

Impact of Dietary Calcium Supplement on Circulating Lipoprotein Concentrations and Atherogenic Indices in Overweight and Obese Individuals: A Systematic Review.

PubMed

Heshmati, Javad; Sepidarkish, Mahdi; Namazi, Nazli; Shokri, Fatemeh; Yavari, Mahsa; Fazelian, Siavash; Khorshidi, Masoud; Shidfar, Farzad

2018-03-21

Dyslipidemia is the main risk factor for developing cardiovascular disease. There are discrepancies in the effects of calcium supplementation on modulation of lipid status. Therefore, we aimed to summarize the effects of dietary calcium supplement on circulating lipoprotein concentrations and atherogenic indices in overweight and obese individuals. We conducted a systematic literature search from 2000 until July 2016. PubMed, Scopus, Cochran Library, and ISI Web of Science databases were searched for clinical trials written in English. Placebo controlled clinical trials on calcium or calcium with vitamin D supplement in overweight and obese indiciduals were considered. Finally, 11 clinical trials met the criteria and were included. Most studies (n = 9) evaluated Ca/D co-supplementation. Positive effects of calcium supplementation alone or with vitamin D were as follows: serum levels of total cholesterol (TC; n = 1), triglyceride (TG) concentrations (n = 1), serum levels of low-density lipoprotein cholesterol (LDL-C; n = 5) and high-density lipoprotein cholesterol (HDL-C; n = 3). Seven clinical trials reported atherogenic indices and three of them demonstrated beneficial effects of calcium supplementation on at least one atherogenic index. Calcium supplementation may not be helpful to reduce serum levels of TC and TG in overweight and obese individuals. However, it may modulate LDL-C and HDL-C concentration. More studies are warranted to clarify the effects of calcium supplementation on each atherogenic index.

Assessing patients' attitudes towards dietary supplements.

PubMed

Wierzejska, Regina; Jarosz, Mirosław; Siuba, Magdalena; Rambuszek, Michał

2014-01-01

There is currently many over the counter products on the market that exert nutritional or physiological effects on the human body. The differences between dietary supplements and non-prescription drugs are however poorly understood by the average consumer and may thus affect their expectations as to the desired effect produced on the body. To evaluate patients' knowledge and attitudes towards dietary supplements as compared to non-prescription drugs. Subjects were 335 patients of the Mazowiecki Voivodeship Hospital in Warsaw, Poland. The data were collected from a face-to-face interview using a single and multiple choice questionnaire with 10 questions on dietary supplements. Statistical analysis used the Chi-square (χ2) test. The majority of respondents were found to be familiar with the term 'dietary supplements', but had difficulties in classifying these products into appropriate categories. Over 55% do not consider dietary supplements to be foodstuffs and more than 40% considered such products to be drugs. Most respondents thought that the main purpose of taking dietary supplements is to improve nutrition, but over one third expected them to also treat disease. Over 70% declared taking notice to which category the non-prescription products they bought belongs to ie. whether non-prescription drugs (medicinal products) or dietary supplements. Many patients mistakenly believe that dietary supplements are drugs and can be used to treat disease and health disorders. dietary supplements, opinion on dietary supplements, nutrition, dietary supplement vs. medicinal product.

Dietary supplement consumption among cardiac patients admitted to internal medicine and cardiac wards.

PubMed

Karny-Rahkovich, Orith; Blatt, Alex; Elbaz-Greener, Gabby Atalya; Ziv-Baran, Tomer; Golik, Ahuva; Berkovitch, Matityahu

2015-01-01

Dietary supplements may have adverse effects and potentially interact with conventional medications. They are perceived as "natural" products, free of side effects with no need for medical consultation. Little is known about consumption of dietary supplements by patients with cardiac diseases. The objective of this study was to investigate dietary supplement consumption among cardiac patients admitted to internal and cardiology wards. Potential drug-dietary supplement interactions were also assessed. During a period of 6 months, patients with cardiac disease hospitalized in the Internal Medicine and Cardiology Wards at Assaf Harofeh Medical Center were evaluated regarding their dietary supplement consumption. A literature survey examining possible drug-supplement interaction was performed. Out of 149 cardiac patients, 45% were dietary supplement consumers. Patients ad-mitted to the Internal Medicine Wards consumed more dietary supplements than those admit-ted to the Cardiology Division. Dietary supplement consumption was associated with older age (OR = 1.05, p = 0.022), female gender (OR = 2.94, p = 0.014) and routine physical activity (OR = 3.15, p = 0.007). Diabetes mellitus (OR = 2.68, p = 0.020), hematological diseases (OR = 13.29, p = 0.022), and the use of anti-diabetic medications (OR = 4.28, p = 0.001) were independently associated with dietary supplement intake. Sixteen potential moderate interactions between prescribed medications and dietary supplements were found. Consumption of dietary supplements is common among cardiac patients. It is more common in those admitted to Internal Medicine Departments than in those admitted to the Cardiology Wards. Due to the risk of various drug-supplement interactions consumed by patients with cardiac diseases, there is a need to increase awareness and knowledge among medical staff regarding the intake of dietary supplements.

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 101.93 - Certain types of statements for dietary supplements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... dietary supplements. (a)(1) No later than 30 days after the first marketing of a dietary supplement that... manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

Inappropriate usage of dietary supplements in patients by miscommunication with physicians in Japan.

PubMed

Chiba, Tsuyoshi; Sato, Yoko; Nakanishi, Tomoko; Yokotani, Kaori; Suzuki, Sachina; Umegaki, Keizo

2014-11-26

Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements.

Inappropriate Usage of Dietary Supplements in Patients by Miscommunication with Physicians in Japan

PubMed Central

Chiba, Tsuyoshi; Sato, Yoko; Nakanishi, Tomoko; Yokotani, Kaori; Suzuki, Sachina; Umegaki, Keizo

2014-01-01

Recently, people have used dietary supplements not only for nutritional supplementation, but also for treatment of their diseases. However, use of dietary supplements to treat diseases, especially with medications, may cause health problems in patients. In this study, we investigated use of dietary supplements in patients in Japan. This survey was conducted from January to December 2012, and was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about dietary supplements. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using dietary supplements, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses. The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used dietary supplements to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using dietary supplements concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention dietary supplement use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with dietary supplements. Communication between patients and physicians is important to avoid health problems associated with the use of dietary supplements. PMID:25431879

Determinants of dietary supplement use--healthy individuals use dietary supplements.

PubMed

Kofoed, Christina L F; Christensen, Jane; Dragsted, Lars O; Tjønneland, Anne; Roswall, Nina

2015-06-28

The prevalence of dietary supplement use varies largely among populations, and previous studies have indicated that it is high in the Danish population compared with other European countries. The diversity in supplement use across countries indicates that cultural and environmental factors could influence the use of dietary supplements. Only few studies investigating the use of dietary supplements have been conducted in the Danish population. The present cross-sectional study is based on 54,948 Danes, aged 50-64 years, who completed self-administrated questionnaires on diet, dietary supplements and lifestyle between 1993 and 1997. A health index including smoking, physical activity, alcohol and diet, and a metabolic risk index including waist circumference, urinary glucose and measured hypertension were constructed. Logistic regression was used to investigate these determinants in relation to the intake of dietary supplements. We found that 71 % of the participants were dietary supplement users; female sex, older age groups and higher educated participants were more likely to be users of any dietary supplements. One additional point in the health index was associated with 19, 16 and 9 % higher likelihood of being user of any, more common and less common supplements, respectively. In the metabolic risk index, one additional point was associated with 17 and 16 % lower likelihood of being user of any supplement and more common supplements, respectively. No significant association was found for less common supplement use. In conclusion, those with the healthiest lifestyle were more likely to use dietary supplements. Thus, lifestyle and dietary composition should be considered as confounders on supplement use and health outcomes.

Long chain omega-3 dietary supplements: a review of the National Library of Medicine Herbal Supplement Database.

PubMed

Zargar, Atanaz; Ito, Matthew K

2011-08-01

Dietary fish oil supplements are increasingly used as an alternative to prescription-grade omega-3 fatty acids (P-OM3) for the treatment of hypertriglyceridemia. The content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in these supplement products varies widely and may result in a suboptimal response. The aim of this study was to review marketed fish oil supplements and to develop a reference for clinicians to compare products. The National Library of Medicine Herbal Supplement Database was systematically searched using fish oil, EPA, DHA, and omega-3 fatty acid as search terms. Daily doses needed to achieve the Food and Drug Administration (FDA)-approved dose (RxDose) (3,360 mg of combined EPA and DHA) were calculated from the milligrams of EPA and DHA per serving, and suggested retail prices were used to calculate monthly cost of each product. A "usage criteria" was set to highlight products at the RxDose with a monthly cost of <$50, daily servings <8, daily amount of vitamins A and D less than or equal to the U.S. Dietary Reference Intake upper limit defined as 10,000 and 4,000 IU, respectively, and if the product was U.S. Pharmacopeia verified. A total of 163 products were identified, and 102 nonliquid and liquid products met our entry criteria. The median amount of EPA and DHA per serving in the nonliquid products was 216 mg and 200 mg, respectively, and the median number of servings at the RxDose was 11.2 at a median monthly cost of $63.49. The median amount of EPA (460 mg) and DHA (400 mg) per serving in the liquid products was higher than the nonliquid products. Thus, the median number of servings at the RxDose was only 3.6 teaspoons and the median monthly cost of $13.60. Only 22% of products met our "usage criteria." The amount of EPA and DHA per recommended serving in these products was highly variable. Clinicians should heighten their scrutiny in terms of selection of the appropriate product.

Dietary Supplements

MedlinePlus

... For Consumers Consumer Information by Audience For Women Dietary Supplements: Tips for Women Share Tweet Linkedin Pin it ... or 10877-382-4357. To Learn More about Dietary Supplements Information for Consumers on Using Dietary Supplements NIH ...

Omega-3 dietary supplements and the risk of cardiovascular events: a systematic review.

PubMed

Marik, Paul E; Varon, Joseph

2009-07-01

Epidemiologic data suggest that omega-3 fatty acids derived from fish oil reduce cardiovascular disease. The clinical benefit of dietary fish oil supplementation in preventing cardiovascular events in both high and low risk patients is unclear. To assess whether dietary supplements of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) decrease cardiovascular events across a spectrum of patients. MEDLINE, Embase, the Cochrane Database of Systematic Reviews, and citation review of relevant primary and review articles. Prospective, randomized, placebo-controlled clinical trials that evaluated clinical cardiovascular end points (cardiovascular death, sudden death, and nonfatal cardiovascular events) and all-cause mortality in patients randomized to EPA/DHA or placebo. We only included studies that used dietary supplements of EPA/DHA which were administered for at least 1 year. Data were abstracted on study design, study size, type and dose of omega-3 supplement, cardiovascular events, all-cause mortality, and duration of follow-up. Studies were grouped according to the risk of cardiovascular events (high risk and moderate risk). Meta-analytic techniques were used to analyze the data. We identified 11 studies that included a total of 39 044 patients. The studies included patients after recent myocardial infarction, those with an implanted cardioverter defibrillator, and patients with heart failure, peripheral vascular disease, and hypercholesterolemia. The average dose of EPA/DHA was 1.8 +/- 1.2 g/day and the mean duration of follow-up was 2.2 +/- 1.2 years. Dietary supplementation with omega-3 fatty acids significantly reduced the risk of cardiovascular deaths (odds ratio [OR]: 0.87, 95% confidence interval [CI]: 0.79-0.95, p = 0.002), sudden cardiac death (OR: 0.87, 95% CI: 0.76-0.99, p = 0.04), all-cause mortality (OR: 0.92, 95% CI: 0.85-0.99, p = 0.02), and nonfatal cardiovascular events (OR: 0.92, 95% CI: 0.85-0.99, p = 0.02). The mortality benefit was largely due to the studies which enrolled high risk patients, while the reduction in nonfatal cardiovascular events was noted in the moderate risk patients (secondary prevention only). Meta-regression failed to demonstrate a relationship between the daily dose of omega-3 fatty acid and clinical outcome. Dietary supplementation with omega-3 fatty acids should be considered in the secondary prevention of cardiovascular events.

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false When must a returned dietary supplement be... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.515 When must a returned dietary supplement be destroyed, or otherwise...

Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.

PubMed

Dodge, Tonya; Litt, Dana; Kaufman, Annette

2011-03-01

The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

Beware of Fraudulent 'Dietary Supplements'

MedlinePlus

... Home For Consumers Consumer Updates Beware of Fraudulent Dietary Supplements Share Tweet Linkedin Pin it More sharing options ... phone at 1-800-FDA-1088 or online . Dietary Supplements and FDA Dietary supplements, in general, are not ...

Using Dietary Supplements Wisely

MedlinePlus

... T U V W X Y Z Using Dietary Supplements Wisely Share: On This Page Key Points About ... will help ensure coordinated and safe care. About Dietary Supplements Dietary supplements were defined in a law passed ...

Greater Total Antioxidant Capacity from Diet and Supplements Is Associated with a Less Atherogenic Blood Profile in U.S. Adults.

PubMed

Kim, Kijoon; Vance, Terrence M; Chun, Ock K

2016-01-04

Evidence from epidemiologic studies has shown that total antioxidant capacity (TAC) in the diet might be inversely associated with stroke, heart failure, and inflammatory biomarkers. However, studies on the association of TAC from both diet and supplements with cardiovascular disease (CVD) risk factors in the U.S. population are lacking. This cross-sectional population-based study aimed to investigate the association of TAC with both diet and supplements with CVD risk factors among 4039 U.S. adults in National Health and Nutrition Examination Survey (NHANES) 2007-2012. TAC from both food sources and dietary supplements was estimated from two 24-h dietary recalls using the NHANES supplement ingredient database, United States Department of Agriculture (USDA) proanthocyanidin, flavonoid, and isoflavone databases. Top contributors to TAC were tea, antioxidant supplements, vegetable mixture, orange juice, berries, and wine. Antioxidant supplement users had 1.6 times higher TAC than non-users. Greater TAC was associated with reduced triglycerides (TG) (-1.39% change; 95% CI = -2.56 to -0.21), TG to high-density lipoprotein cholesterol (HDL-C) ratio (-2.03% change; 95% CI = -3.45 to -0.60), HDL-C (0.65% change; 95% CI = 0.07 to 1.23), insulin (-1.37% change; 95% CI = -2.64 to -0.09), homeostasis model assessment of insulin resistance (HOMA-IR) (-1.57% change; 95% CI = -3.02 to -0.09) and C-reactive protein (CRP) (-0.83% change; 95% CI = -1.29 to -0.38) after adjusting for potential confounders. There was no significant association between TAC and waist circumference, BMI, blood pressure, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and fasting glucose. The findings of this study support the hypothesis that an antioxidant-rich diet and intake of supplements are beneficial to reduce CVD risk.

Greater Total Antioxidant Capacity from Diet and Supplements Is Associated with a Less Atherogenic Blood Profile in U.S. Adults

PubMed Central

Kim, Kijoon; Vance, Terrence M.; Chun, Ock K.

2016-01-01

Evidence from epidemiologic studies has shown that total antioxidant capacity (TAC) in the diet might be inversely associated with stroke, heart failure, and inflammatory biomarkers. However, studies on the association of TAC from both diet and supplements with cardiovascular disease (CVD) risk factors in the U.S. population are lacking. This cross-sectional population-based study aimed to investigate the association of TAC with both diet and supplements with CVD risk factors among 4039 U.S. adults in National Health and Nutrition Examination Survey (NHANES) 2007–2012. TAC from both food sources and dietary supplements was estimated from two 24-h dietary recalls using the NHANES supplement ingredient database, United States Department of Agriculture (USDA) proanthocyanidin, flavonoid, and isoflavone databases. Top contributors to TAC were tea, antioxidant supplements, vegetable mixture, orange juice, berries, and wine. Antioxidant supplement users had 1.6 times higher TAC than non-users. Greater TAC was associated with reduced triglycerides (TG) (−1.39% change; 95% CI = −2.56 to −0.21), TG to high-density lipoprotein cholesterol (HDL-C) ratio (−2.03% change; 95% CI = −3.45 to −0.60), HDL-C (0.65% change; 95% CI = 0.07 to 1.23), insulin (−1.37% change; 95% CI = −2.64 to −0.09), homeostasis model assessment of insulin resistance (HOMA-IR) (−1.57% change; 95% CI = −3.02 to −0.09) and C-reactive protein (CRP) (−0.83% change; 95% CI = −1.29 to −0.38) after adjusting for potential confounders. There was no significant association between TAC and waist circumference, BMI, blood pressure, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and fasting glucose. The findings of this study support the hypothesis that an antioxidant-rich diet and intake of supplements are beneficial to reduce CVD risk. PMID:26742057

Dietitians use and recommend dietary supplements: report of a survey.

PubMed

Dickinson, Annette; Bonci, Leslie; Boyon, Nicolas; Franco, Julio C

2012-03-14

Dietary supplement use is common in the United States, with more than half of the population using such products. Nutrition authorities consistently advocate a "food first" approach to achieving nutritional adequacy but some, including the Academy of Nutrition and Dietetics (formerly the American Dietetic Association), also recognize that dietary supplements have a role to play in improving nutrient intake to support health and wellness. Surveys show that many health professionals use dietary supplements themselves and also recommend dietary supplements to their patients or clients. As one component of a series of surveys of healthcare professionals (the "Life...supplemented" HCP Impact Studies), 300 registered dietitians were surveyed in 2009 regarding their personal use of dietary supplements and whether they recommend dietary supplements to their clients. Respondents were registered dietitians whose business involved seeing clients in a private practice or at a clinic. Seventy-four percent of the dietitians surveyed said they were regular users of dietary supplements, while 22% said they used dietary supplements occasionally or seasonally. The primary reasons for using dietary supplements were for bone health (58%), overall health and wellness (53%), and to fill nutrient gaps (42%). When asked if they "ever recommend dietary supplements to clients," 97% of the respondents said they did. The primary reasons were for bone health (70%), to fill nutrient gaps (67%), and overall health and wellness (49%). Eighty-seven percent of the dietitians agreed with the statement, "There are gaps in clients' diets that could effectively be addressed with dietary supplements." The dietitians surveyed said they followed healthy habits including eating a balanced diet (96%), managing stress (92%), visiting their own healthcare professional regularly (86%), exercising regularly (83%), maintaining a healthy weight (80%), and getting a good night's sleep (72%). Nearly all respondents (95%) expressed an interest in continuing education about dietary supplements on a variety of topics. Many dietitians, like other health professionals, use dietary supplements regularly as part of their own approach to a healthy diet and lifestyle. They also recommend dietary supplements to their clients or patients, to promote health. © 2012 Dickinson et al; licensee BioMed Central Ltd.

A cross-sectional survey on dietary supplements consumption among Italian teen-agers.

PubMed

del Balzo, Valeria; Vitiello, Valeria; Germani, Alessia; Donini, Lorenzo M; Poggiogalle, Eleonora; Pinto, Alessandro

2014-01-01

In the last decades, dietary supplements consumption has increased in the Western world for all age groups. The long-term potentially dangerous effects related to an indiscriminate consumption of dietary supplements are still unknown and are becoming a matter of public health concern. Therefore, the aims of the present study were: to explore the contribution of dietary supplements to micronutrient daily intake, and to evaluate awareness and knowledge about dietary supplements. Participants (age ranging from 14 to 18 years) were recruited among students attending 8 high schools in the province of Frosinone (Italy). An anonymous questionnaire, composed of 12 multiple-choice items, was administered to all the participants. T-test and the analysis of variance (ANOVA) were performed to describe differences between means of the groups, while the chi-square test was used to compare observed and expected frequencies. The logistic regression model, aimed at identifying the characteristics of potential consumers of dietary supplements. A total of 686 teenagers (288 males and 398 females, average age: 17,89±0,91 years) participated in the study. The 83,6% of participants affirmed to be aware of dietary supplements. 239 participants consumed dietary supplements: 118 males and 121 females. 49,1% of females consumed dietary supplements less than twice a week, whereas 43,6% of males consumed dietary supplements from 2 to 5 times per week. Statistically significant differences emerged between the genders with respect to the source of information regarding dietary supplements, the perceived indications for their use, and the choice of the store/place to purchase them. Findings in the present study provide insight into the consumption of dietary supplements among young Italians, highlighting the need to foster further awareness among adolescents about the correct use of dietary supplements, especially in terms of indications and contraindications.

Dietary Supplements: What You Need to Know

MedlinePlus

... Products Food Home Food Resources for You Consumers Dietary Supplements: What You Need to Know Share Tweet Linkedin ... foods and nutrients you personally need. What are dietary supplements? Dietary supplements include such ingredients as vitamins, minerals, ...

Hepatitis C and Dietary Supplements: What the Science Says

MedlinePlus

... Health NCCIH Clinical Digest for health professionals Hepatitis C and Dietary Supplements: What the Science Says Share: ... Clinical Guidelines, Scientific Literature, Info for Patients: Hepatitis C and Dietary Supplements Dietary Supplements Milk Thistle Milk ...

Analytical ingredient content and variability of adult multivitamin/mineral products: national estimates for the Dietary Supplement Ingredient Database12

PubMed Central

Andrews, Karen W; Roseland, Janet M; Gusev, Pavel A; Palachuvattil, Joel; Dang, Phuong T; Savarala, Sushma; Han, Fei; Pehrsson, Pamela R; Douglass, Larry W; Dwyer, Johanna T; Betz, Joseph M; Saldanha, Leila G; Bailey, Regan L

2017-01-01

Background: Multivitamin/mineral products (MVMs) are the dietary supplements most commonly used by US adults. During manufacturing, some ingredients are added in amounts exceeding the label claims to compensate for expected losses during the shelf life. Establishing the health benefits and harms of MVMs requires accurate estimates of nutrient intake from MVMs based on measures of actual rather than labeled ingredient amounts. Objectives: Our goals were to determine relations between analytically measured and labeled ingredient content and to compare adult MVM composition with Recommended Dietary Allowances (RDAs) and Tolerable Upper Intake Levels. Design: Adult MVMs were purchased while following a national sampling plan and chemically analyzed for vitamin and mineral content with certified reference materials in qualified laboratories. For each ingredient, predicted mean percentage differences between analytically obtained and labeled amounts were calculated with the use of regression equations. Results: For 12 of 18 nutrients, most products had labeled amounts at or above RDAs. The mean measured content of all ingredients (except thiamin) exceeded labeled amounts (overages). Predicted mean percentage differences exceeded labeled amounts by 1.5–13% for copper, manganese, magnesium, niacin, phosphorus, potassium, folic acid, riboflavin, and vitamins B-12, C, and E, and by ∼25% for selenium and iodine, regardless of labeled amount. In contrast, thiamin, vitamin B-6, calcium, iron, and zinc had linear or quadratic relations between the labeled and percentage differences, with ranges from −6.5% to 8.6%, −3.5% to 21%, 7.1% to 29.3%, −0.5% to 16.4%, and −1.9% to 8.1%, respectively. Analytically adjusted ingredient amounts are linked to adult MVMs reported in the NHANES 2003–2008 via the Dietary Supplement Ingredient Database (http://dsid.usda.nih.gov) to facilitate more accurate intake quantification. Conclusions: Vitamin and mineral overages were measured in adult MVMs, most of which already meet RDAs. Therefore, nutrient overexposures from supplements combined with typical food intake may have unintended health consequences, although this would require further examination. PMID:27974309

Dietary Supplement Intake and Associated Factors Among Gym Users in a University Community.

PubMed

Attlee, Amita; Haider, Amina; Hassan, Asma; Alzamil, Noura; Hashim, Mona; Obaid, Reyad Shaker

2018-01-02

Dietary supplement intake and associated factors among gym users in a university community in Sharjah, United Arab Emirates (UAE), were assessed using a structured, self-administered questionnaire in this cross-sectional study. Adults (N = 320) from five gyms in the University City of Sharjah participated in this cross-sectional study. The prevalence of dietary supplement intake was 43.8%. Statistically significant associations were found between the use of dietary supplements and sex (47.7% males, 28.1% females; p = .006), as well as weight lifting (88.6% taking supplements vs. 11.4% not taking supplements; p < .001), favoring male gym users. The reasons attributed to the use of dietary supplements varied between the sexes. Male exercisers used supplements to increase or maintain muscles mass, strength, and power and to boost exercise recovery. Females mainly used dietary supplements to increase energy, maintain their health, and prevent nutrition deficiency. Overall, protein supplements (whey proteins [48.6%] and protein powder [45.7%]) were among the most-consumed dietary supplements, followed by multivitamins (38.6%), branched-chain amino acids (36.4%), caffeine (35.0%), and creatine (29.3%). A widespread use of Internet-driven, self-prescribed dietary supplement intake was reported among gym users (60.7%). Only 12.8% of dietary supplement users sought information from dietitians. Practical implications suggest that gym instructors and coaches should be sufficiently trained to be able to provide accurate and scientifically sound information on dietary supplements to the exercisers in gyms in the university environment.

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.155 - What requirements apply to components of dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.155 What requirements apply to components of dietary... components before you use them in the manufacture of a dietary supplement until: (1) You collect...

Herbal Supplements: What to Know Before You Buy

MedlinePlus

... supplements, sometimes called botanicals, are one type of dietary supplement available for purchase. Herbal supplements aren't new — ... as foods. They fall under a category called dietary supplements. The rules for dietary supplements are as follows: ...

Attitudes, beliefs and behaviours of Australia dietitians regarding dietary supplements: A cross-sectional survey.

PubMed

Marx, Wolfgang; Kiss, Nicole; McKavanagh, Daniel; Isenring, Elisabeth

2016-11-01

The aim of this study was to investigate the attitudes, beliefs and behaviors of Australian dietitians regarding dietary supplements. An online survey was disseminated through the mailing lists of multiple healthcare organizations. There were 231 Australian dietitians that replied to the online survey. The results indicate that Australian dietitians are interested in dietary supplements (65%); however, the results also indicate that Australian dietitians are tentative about integrating dietary supplements into their dietetic practice. Concerns regarding potential drug-nutrient/herbal interactions were reported as the primary barrier (67%) to utilizing dietary supplements as part of clinical practice. In addition, there was a strong interest in additional training in dietary supplements (79%). In summary, Australian dietitians are interested in the use of dietary supplements; however, due to current barriers, few dietitians utilize dietary supplements as part of dietetic practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification... for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient... dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements...

The Prevalence of Dietary Supplement Use among College Students: A Nationwide Survey in Japan

PubMed Central

Kobayashi, Etsuko; Sato, Yoko; Umegaki, Keizo

2017-01-01

To clarify the prevalence of dietary supplement use among college students, we conducted Internet-based nationwide questionnaire surveys with 157,595 Japanese college students aged between 18 to 24 years old who were registrants of Macromill Inc. (Tokyo, Japan). Among the 9066 respondents (response rate 5.8%), 16.8% were currently using dietary supplements. The prevalence of dietary supplement use did not differ significantly between males (17.1%) and females (16.7%). However, it increased according to their grade (13.1% to 20.5%), and it was higher in medical and pharmaceutical college students (22.0%) compared to others (16.7%). The main purpose of dietary supplement use was for the health benefits in both males and females. Other reasons were to build muscle in males, and as a beauty supplement and for weight loss in females. According to the purpose of dietary supplement use, the most commonly-used dietary supplements were vitamin/mineral supplements in both males and females, then protein and weight loss supplements in males and females, respectively. Although most students obtained information about dietary supplements via the Internet, they typically purchased the supplements from drug stores. Of the students surveyed, 7.5% who were currently using or used to use dietary supplements experienced adverse effects, with no significant difference between genders (8.8% in male, 7.0% in female). In conclusion, the prevalence of dietary supplement use increased with grade among college students in Japan. Some of them experienced adverse effects. Education may be important to prevent adverse effects resulting from supplement use in college. PMID:29140269

Estimation of dietary supplements intake in a selected group of women over 50 and the risk assessment of interactions between the ingredients of dietary supplements and drugs

PubMed

Sadowska, Joanna; Bruszkowska, Magda

Concurrent use of dietary supplements and drugs may result in complications of pharmacotherapy due to possible interactions between their ingredients. The aim of the survey was to estimate the intake of dietary supplements in a group of women over 50 and to analyse the risk of interactions between the ingredients of dietary supplements and drugs taken by the women. The study was carried out among 146 women over 50 years of age. Questionnaire included detailed questions on the type of prescription drugs, OTC (over-the-counter) drugs, and dietary supplements taken. The risk of interactions was determined on the basis of chemical composition of the drugs and supplements specified by the manufacturer, by comparing the obtained data with literature reports on known interactions. The analysis has shown that 88.4% of respondents constantly took prescription drugs, 44.5% of them took OTC drugs, and 66.4% of respondents took dietary supplements throughout the survey period. It has been found that 71.3% of surveyed women taking prescription drugs, took dietary supplements as well. Among women taking supplements and drugs, 36.9% of respondents were taking them concurrently, 60.9% kept such an interval, but only 21.8% of them waited for at least two hours. It has been found that the drug-supplement interactions might occur in 35.8% women under the survey. The analysis of the obtained results has revealed that taking dietary supplements by the group under survey was frequent, and the risk of interactions between dietary supplements and drugs was significant. It is recommended that doctors ask their patients about taken supplements during regular check-ups, and inform them about possible interactions between dietary supplements and drugs. Moreover, appropriate would be to change the labelling of dietary supplements, so that the packaging provides information on possible interactions between their ingredients and drugs.

Environmental influences: factors influencing a woman's decision to use dietary supplements.

PubMed

Conner, Mark; Kirk, Sara F L; Cade, Janet E; Barrett, Jennifer H

2003-06-01

Use of dietary supplements by women, particularly those over 40 years of age may be widespread in the United Kingdom. However, from surveillance data, there appears to be a disparity between nutrition and health needs and the rationale for and actual use of dietary supplements by women. This apparent paradox forms the basis for an inverse supplement hypothesis (i.e., supplement use in women appears to be most prevalent among those with least need). Little research has been done to examine the factors underlying the decision to use dietary supplements. Reasons for consuming dietary supplements are often complex, combining social, psychological, knowledge and economic factors. The theory of planned behavior is a widely used model for assessing factors influencing behavioral motivation and action that may be useful for assessing specific diet- and nutrition-related practices. It provided the basis for the development of a questionnaire to explore overall dietary supplement use in a cohort of women in the United Kingdom. The analysis of factors related to beliefs underlying dietary supplement use revealed differences between supplement users and nonusers. Differences included a stronger belief by users than nonusers that taking dietary supplements ensures against possible ill health. Both users and nonusers of supplements also perceived the media (books and magazines) to be a powerful influence on a person's decision to use supplements. These findings highlight the potential of the theory of planned behavior in exploring supplement-taking behavior while throwing light on the factors influencing an individual's motivations to use dietary supplements.

78 FR 4153 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

...; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION... dietary supplements to notify us that they are marketing a dietary supplement product that bears on its... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a...

Dietary Supplement Use in the United States, 2003–20061

PubMed Central

Bailey, Regan L.; Gahche, Jaime J.; Lentino, Cindy V.; Dwyer, Johanna T.; Engel, Jody S.; Thomas, Paul R.; Betz, Joseph M.; Sempos, Christopher T.; Picciano, Mary Frances

2011-01-01

Dietary supplement use has steadily increased over time since the 1970s; however, no current data exist for the U.S. population. Therefore, the purpose of this analysis was to estimate dietary supplement use using the NHANES 2003–2006, a nationally representative, cross-sectional survey. Dietary supplement use was analyzed for the U.S. population (≥1 y of age) by the DRI age groupings. Supplement use was measured through a questionnaire and was reported by 49% of the U.S. population (44% of males, 53% of females). Multivitamin-multimineral use was the most frequently reported dietary supplement (33%). The majority of people reported taking only 1 dietary supplement and did so on a daily basis. Dietary supplement use was lowest in obese adults and highest among non-Hispanic whites, older adults, and those with more than a high-school education. Between 28 and 30% reported using dietary supplements containing vitamins B-6, B-12, C, A, and E; 18–19% reported using iron, selenium, and chromium; and 26–27% reported using zinc- and magnesium-containing supplements. Botanical supplement use was more common in older than in younger age groups and was lowest in those aged 1–13 y but was reported by ~20% of adults. About one-half of the U.S. population and 70% of adults ≥ 71 y use dietary supplements; one-third use multivitamin-multimineral dietary supplements. Given the widespread use of supplements, data should be included with nutrient intakes from foods to correctly determine total nutrient exposure. PMID:21178089

Herbal medications and other dietary supplements. A clinical review for physicians caring for older people.

PubMed

Pitkälä, Kaisu H; Suominen, Merja H; Bell, J Simon; Strandberg, Timo E

2016-12-01

Evidence for the safety and effectiveness of dietary supplements is mixed. The extent to which older people use dietary supplements concomitantly with conventional medications is often under-appreciated by physicians. We conducted a literature review on clinical considerations associated with dietary supplement use, focusing on benefits and harms, motivations for use and contribution to polypharmacy among older people. Vitamin D ≥ 800 IU has demonstrated benefits in fracture prevention. Vitamins A, E, and β-carotene have been associated with an increase in total mortality in several meta-analyses. A range of non-vitamin dietary supplements have been studied in randomized controlled trials but their efficacy remains largely unclear. Supplement use has been associated with a range of adverse events and drug interactions yet physicians rarely initiate discussions about their use with older patients. Older people may take dietary supplements to exercise control over their health. Given the contribution of supplements to polypharmacy, supplements may be targeted for "deprescribing" if the risk of harm is judged to outweigh benefits. This is best done as part of a comprehensive, patient-centered approach. A respectful and non-judgmental discussion may result in a shared decision to reduce polypharmacy through cessation of dietary supplements. KEY MESSAGES Herbal medications and other dietary supplements are highly prevalent among older people. Physicians are often unaware that their patients use herbal medications and other dietary supplements concomitantly with conventional medications. Herbal medications and other dietary supplements contribute to high rates of polypharmacy, particularly among older people with multimorbidity. Herbal medications and other dietary supplements can interact with conventional medications and be associated with a range of adverse events. Physicians need to be patient-centered and non-judgmental when initiating discussions about herbal medications and other dietary supplements. This is important to maintain and develop patient empowerment and self-management skills.

Dietary Supplement Polypharmacy: An Unrecognized Public Health Problem?

PubMed Central

Gryzlak, Brian M.; Zimmerman, M. Bridget; Wallace, Robert B.

2010-01-01

Excessive and inappropriate use of medications, or ‘polypharmacy’, has been recognized as a public health problem. In addition, there is growing use of dietary supplements in the United States; however, little is known about the patterns of supplement use. Recent reports in the literature of cases of excessive or inappropriate use of herbal dietary supplements leading to the term ‘polyherbacy’. The clinical vignettes described in this article highlight the need for further research on the nature and extent of multiple and inappropriate dietary supplement use or ‘dietary supplement polypharmacy’. Clinical interviewing and population surveys both address this issue in complementary ways, and provide a further understanding of dietary supplement use patterns. PMID:18955288

Use of Iodine-Containing Dietary Supplements Remains Low among Women of Reproductive Age in the United States: NHANES 2011-2014.

PubMed

Gupta, Priya M; Gahche, Jaime J; Herrick, Kirsten A; Ershow, Abby G; Potischman, Nancy; Perrine, Cria G

2018-03-29

In the United States, the American Thyroid Association recommends that women take a dietary supplement containing 150 µg of iodine 3 months prior to conception and while pregnant and lactating to support fetal growth and neurological development. We used data from the National Health and Nutrition Examination Survey 2011–2014 to describe the use of dietary supplements with and without iodine in the past 30 days among 2155 non-pregnant, non-lactating (NPNL) women; 122 pregnant women; and 61 lactating women. Among NPNL women, 45.3% (95% Confidence Interval [CI]: 42.0, 48.6) used any dietary supplement and 14.8% (95% CI: 12.7, 16.8) used a dietary supplement with iodine in the past 30 days. Non-Hispanic black and Hispanic women were less likely to use any dietary supplement as well as one with iodine, than non-Hispanic white or non-Hispanic Asian women ( p < 0.05). Among pregnant women, 72.2% (95% CI: 65.8, 78.6) used any dietary supplement; however, only 17.8% (95% CI: 11.4, 24.3) used a dietary supplement with iodine. Among lactating women, 75.0% (95% CI: 63.0, 87.0) used a dietary supplement; however, only 19.0% (95% CI: 8.8, 29.2) used a dietary supplement with iodine. Among NPNL women using a supplement with iodine, median daily iodine intake was 75.0 µg. Self-reported data suggests that the use of iodine containing dietary supplements among pregnant and lactating women remains low in contrast with current recommendations.

Use of Iodine-Containing Dietary Supplements Remains Low among Women of Reproductive Age in the United States: NHANES 2011–2014

PubMed Central

Gupta, Priya M.; Gahche, Jaime J.; Herrick, Kirsten A.; Ershow, Abby G.; Potischman, Nancy; Perrine, Cria G.

2018-01-01

In the United States, the American Thyroid Association recommends that women take a dietary supplement containing 150 µg of iodine 3 months prior to conception and while pregnant and lactating to support fetal growth and neurological development. We used data from the National Health and Nutrition Examination Survey 2011–2014 to describe the use of dietary supplements with and without iodine in the past 30 days among 2155 non-pregnant, non-lactating (NPNL) women; 122 pregnant women; and 61 lactating women. Among NPNL women, 45.3% (95% Confidence Interval [CI]: 42.0, 48.6) used any dietary supplement and 14.8% (95% CI: 12.7, 16.8) used a dietary supplement with iodine in the past 30 days. Non-Hispanic black and Hispanic women were less likely to use any dietary supplement as well as one with iodine, than non-Hispanic white or non-Hispanic Asian women (p < 0.05). Among pregnant women, 72.2% (95% CI: 65.8, 78.6) used any dietary supplement; however, only 17.8% (95% CI: 11.4, 24.3) used a dietary supplement with iodine. Among lactating women, 75.0% (95% CI: 63.0, 87.0) used a dietary supplement; however, only 19.0% (95% CI: 8.8, 29.2) used a dietary supplement with iodine. Among NPNL women using a supplement with iodine, median daily iodine intake was 75.0 µg. Self-reported data suggests that the use of iodine containing dietary supplements among pregnant and lactating women remains low in contrast with current recommendations. PMID:29596306

77 FR 31622 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary... Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act--21 U.S.C. 379aa-1(b)(1) (OMB Control Number 0910- 0635)--Extension The Dietary Supplement and...

Why do Dutch people use dietary supplements? Exploring the role of socio-cognitive and psychosocial determinants.

PubMed

Pajor, E M; Eggers, S M; Curfs, K C J; Oenema, A; de Vries, H

2017-07-01

In the Netherlands, the prevalence of dietary supplement use has doubled (from 17 to 40 per cent) since the 1980s. Yet, limited data is available on which socio-cognitive factors are associated with dietary supplement use. Therefore, the purpose of the study is to explain dietary supplement use with determinants deriving from the Integrated Change Model (ICM) and from formative research. Socio-cognitive and psychosocial factors were measured among users and non-users of dietary supplements in a longitudinal survey study, with measurements at baseline (N = 1448) and at one-month follow-up (N = 1161). Negative binomial regression analysis was applied to de data. Intention emerged as the main predictor of dietary supplement use (OR = 1.99). Further predictors of dietary supplement use with smaller effect-sizes were: health regulatory focus (promotion, OR = 1.46), social modelling (OR = 1.44), attitude (pros, OR = 1.37), attitude (cons, OR = 0.87), health locus of control (OR = 0.77), and risk perception (chance of getting ill, OR = 1.22). Individuals tend to use dietary supplements if they are promotion oriented, notice dietary supplement users in their social environment, estimate their chances of getting ill higher, and have positive attitudes towards dietary supplements. In contrast, non-users believe that external factors affect their health, and hold negative attitudes towards dietary supplements. Mapping out individuals' socio-cognitive profile may contribute to the development of online health communication. Based on socio-cognitive and demographical factors, personalised advice can be given about dietary supplement use. Copyright © 2017 Elsevier Ltd. All rights reserved.

Use of dietary supplements by cardiologists, dermatologists and orthopedists: report of a survey

PubMed Central

2011-01-01

Background Dietary supplements are regularly used by a majority of the American population, and usage by health professionals is also common. There is considerable interest in usage patterns within the population and in the reasons for using dietary supplements. The "Life...supplemented" Healthcare Professionals 2008 Impact Study (HCP Impact Study) surveyed usage of dietary supplements by physicians in three specialties: cardiology, dermatology, and orthopedics. Methods The HCP Impact Study was conducted online by Ipsos Public Affairs for the Council for Responsible Nutrition (CRN), a trade association of the dietary supplement industry. Respondents were 900 physicians, including 300 each from three specialties - cardiology, dermatology, and orthopedics. Results Fifty-seven percent of cardiologists said they use dietary supplements at least occasionally, as did 75% of dermatologists and 73% of orthopedists. The product most commonly reported to be used was a multivitamin, but over 25% in each specialty said they used omega-3 fatty acids and over 20% said they used some botanical supplements. Regular dietary supplement use was reported by 37% of cardiologists, 59% of dermatologists, and 50% of orthopedists. Seventy-two percent of cardiologists, 66% of dermatologists, and 91% of orthopedists reported recommending dietary supplements to their patients. The primary reason given for recommending dietary supplements to patients was for heart health or lowering cholesterol for the cardiologists; benefits for skin, hair and nails for the dermatologists; and bone and joint health for the orthopedists. Conclusions Reported dietary supplement use was relatively common in this sample of physicians, and when they recommended dietary supplements to patients, they tended to do so for reasons related to their specialty. PMID:21371318

77 FR 17076 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription... information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). DATES: Submit...

75 FR 9232 - Office of Dietary Supplements (ODS) 2010-2014 Strategic Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

...-2014. SUMMARY: The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has..., entitled Strengthening Knowledge and Understanding of Dietary Supplements. The strategic plan is available... the federal government, academia, the dietary supplement industry, consumer advocacy and education...

The Association between Taking Dietary Supplements and Healthy Habits among Korean Adults: Results from the Fifth Korea National Health and Nutritional Examination Survey (2010-2012).

PubMed

Kim, Jin-Wook; Lee, So-Hye; Kim, Jung-Eun; Han, Kyung-Do; Kwack, Tae-Eung; Kim, Bo-Seon; Kim, Jeong-Eun; Jo, Eun-Bae; Park, Young-Kyu; Lee, Kyung-Shik

2016-05-01

Recently, the number of people interested in health in South Korea has increased, and the rate of dietary supplement use is rising. Researchers have hypothesized that the rate of practicing healthy habits is higher among those who use dietary supplements than those who do not. Therefore, this study aimed to discover the association between taking dietary supplements and practicing various healthy habits in the Korean, adult population. The sample included 15,789 adults over 19 years old who participated in the fifth Korea National Health and Nutrition Examination Survey. The user group was defined as those taking dietary supplements for more than 2 weeks during the previous year or once during the past month. Measures for the seven healthy habits were based on those included in the Alameda study and were analyzed accounting for the complex sampling design. The rate of taking dietary supplements was significantly higher in women, middle aged participants, urban residents, those with a higher income, those with a higher education level, and nonsmokers as well as among women with a moderate subjective health status, women who limited their alcohol content, and women with dyslipidemia. In the adjusted analysis, the rate of performing three of the 'Alameda 7' habits-eating breakfast regularly, restricting snacking, and limiting drinking-was higher in the female dietary supplement user group than in the other groups. Women practiced more healthy habits and had a higher dietary supplement intake rate than men. We found that taking dietary supplements in Korean adults is highly associated with demographic and social factors. Taking dietary supplements had a relationship with dietary habits, and there was no significant association between dietary supplement and other healthy habits. Thus in the health clinic, we suggest that taking dietary supplements complements a patient's healthy habits, with the exception of dietary habits, for health promotion.

The Association between Taking Dietary Supplements and Healthy Habits among Korean Adults: Results from the Fifth Korea National Health and Nutritional Examination Survey (2010–2012)

PubMed Central

Kim, Jin-Wook; Lee, So-Hye; Kim, Jung-Eun; Han, Kyung-Do; Kwack, Tae-Eung; Kim, Bo-Seon; Kim, Jeong-Eun; Jo, Eun-Bae; Park, Young-Kyu

2016-01-01

Background Recently, the number of people interested in health in South Korea has increased, and the rate of dietary supplement use is rising. Researchers have hypothesized that the rate of practicing healthy habits is higher among those who use dietary supplements than those who do not. Therefore, this study aimed to discover the association between taking dietary supplements and practicing various healthy habits in the Korean, adult population. Methods The sample included 15,789 adults over 19 years old who participated in the fifth Korea National Health and Nutrition Examination Survey. The user group was defined as those taking dietary supplements for more than 2 weeks during the previous year or once during the past month. Measures for the seven healthy habits were based on those included in the Alameda study and were analyzed accounting for the complex sampling design. Results The rate of taking dietary supplements was significantly higher in women, middle aged participants, urban residents, those with a higher income, those with a higher education level, and nonsmokers as well as among women with a moderate subjective health status, women who limited their alcohol content, and women with dyslipidemia. In the adjusted analysis, the rate of performing three of the 'Alameda 7' habits—eating breakfast regularly, restricting snacking, and limiting drinking—was higher in the female dietary supplement user group than in the other groups. Women practiced more healthy habits and had a higher dietary supplement intake rate than men. Conclusion We found that taking dietary supplements in Korean adults is highly associated with demographic and social factors. Taking dietary supplements had a relationship with dietary habits, and there was no significant association between dietary supplement and other healthy habits. Thus in the health clinic, we suggest that taking dietary supplements complements a patient's healthy habits, with the exception of dietary habits, for health promotion. PMID:27274390

Use of dietary supplements among gym trainees in Tanta city, Egypt.

PubMed

Abo Ali, Ehab A; Elgamal, Hanan H

2016-12-01

The use of dietary supplements has greatly increased in the past few years. Few studies described the prevalence of supplement use among gym trainees. The practices of most of the athletes and gym trainees in Egypt remain undocumented. This study aimed to assess the prevalence of dietary supplement use among gyms trainees in Tanta city, Egypt. A cross-sectional comparative study was carried out on 450 gym trainees aged more than or equal to 20 years in Tanta city, Egypt. Nine representative gyms (50 participants from each) were recruited in the study. Data on sociodemographic characteristics, health and lifestyle characteristics, type, underlying motive(s), and source(s) of information about dietary supplements were collected from each participant. Of the 450 participants, 38.2% reported using dietary supplements. Male participants and those with higher family incomes used dietary supplements more than female participants and those with lower family incomes (P<0.05). Female participants used vitamins/minerals, weight loss, and natural groups of dietary supplements more than male participants (P<0.05), whereas male participants used body-building group of supplements more than female participants (P<0.05). Participants of older ages (≥30) tended to use the natural group of dietary supplements more than younger ones (P<0.05). Female participants were more motivated to use dietary supplements for the prevention of nutritional and/or medical problems and for weight loss, whereas male participants used dietary supplements for muscle building/repair (P<0.05). Female participants mostly got their information about dietary supplements from health professionals and from the media more than male participants, whereas male participants got this information mainly from gym personnel. A considerable proportion of gym trainees use dietary supplements, mostly without professional consultation and frequently without any indication. It is very important to disseminate accurate information on these products in the sports environment.

Common use of dietary supplements for bipolar disorder: a naturalistic, self-reported study.

PubMed

Bauer, Michael; Glenn, Tasha; Conell, Jörn; Rasgon, Natalie; Marsh, Wendy; Sagduyu, Kemal; Munoz, Rodrigo; Lewitzka, Ute; Bauer, Rita; Pilhatsch, Maximilian; Monteith, Scott; Whybrow, Peter C

2015-12-01

Dietary supplements are taken by about half of Americans. Knowledge of dietary supplement use is important because they may interact with prescription drugs or other supplements, cause adverse reactions including psychiatric symptoms, or contain inherently toxic ingredients or contaminants. This study explores the use of dietary supplements by patients with bipolar disorder in the US. Data were obtained from an ongoing, naturalistic study of patients with bipolar disorder who received pharmacological treatment as usual. The patients self-reported their daily mood, sleep, and medications taken, including all drugs prescribed for bipolar disorder or that the patient felt impacted their mood. These included other prescribed drugs, over-the-counter drugs and dietary supplements. Drugs that received premarketing approval from the FDA were not included as dietary supplements. Patient demographics and daily medication use were characterized. Data were available from 348 patients in the US who returned a mean 249.5 days of data. In addition to prescribed psychiatric drugs, 101 of the 348 patients (29 %) used a dietary supplement for at least 7 days and 69 (20 %) used a supplement long term (for at least 50 % of days). Of the 101 supplement users, 72 (71.3 %) took one supplement daily. The 101 patients tried over 40 different supplements, and the long-term users took 19 different supplements. The most commonly taken supplements for both groups were fish oil, B vitamins, melatonin, and multivitamins. Patients using supplements were more likely to be white (p < 0.001), older (p = 0.009), and ill for more years (p = 0.025). Many patients with bipolar disorder use dietary supplements in addition to prescribed drugs. Physicians should obtain detailed information about all dietary supplements taken by patients with bipolar disorder.

Trends in Dietary Supplement Use in a Cohort of Postmenopausal Women From Iowa

PubMed Central

Park, Kyong; Jacobs, David R.

2009-01-01

Although it is widely known that use of dietary supplements is common in the United States, little is known about use patterns among older Americans. The authors examined trends in dietary supplement use and its contribution to total nutrient intake in the Iowa Women's Health Study cohort in 1986 (baseline) and 2004 (follow-up). The proportion of women who reported using dietary supplements increased substantially between baseline (66%) and follow-up (85%). Moreover, a substantial proportion of women reported using multiple dietary supplements, with 27% using 4 or more products in 2004. Dietary supplements contributed substantially to total intake of many nutrients at baseline, and their contribution became relatively greater at follow-up for most nutrients examined. For most nutrients, no decline in intake was observed, as might have been expected in an aging cohort. Rather, intake of many nutrients increased, primarily because of the rising use of dietary supplements. Use of dietary supplements by older individuals is of particular importance because of the potential benefits of maintaining nutrient intake levels despite potentially declining food intake. However, possible risks from obtaining a large proportion of purified nutrients from dietary supplements rather than deriving them from foods should be studied. PMID:19208725

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

22 CFR 71.12 - Dietary supplements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Dietary supplements. 71.12 Section 71.12... Incarcerated Abroad § 71.12 Dietary supplements. (a) Eligibility criteria. A prisoner is considered eligible for the dietary supplement program under the following general criteria: (1) An evaluation by a...

Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2012 CFR

2012-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2013 CFR

2013-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.465 - What requirements apply to holding reserve samples of dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... of dietary supplements? 111.465 Section 111.465 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.465 What requirements apply to holding reserve samples of dietary supplements? (a) You must...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

21 CFR 101.36 - Nutrition labeling of dietary supplements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Nutrition labeling of dietary supplements. 101.36... (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Nutrition Labeling Requirements and Guidelines § 101.36 Nutrition labeling of dietary supplements. (a) The label of a dietary supplement that is...

78 FR 69095 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... a dietary supplement that contains an NDI, a manufacturer or distributor of dietary supplements or... upon which the manufacturer or distributor has based its conclusion that a dietary supplement... statutory provisions. Section 190.6(a) requires each manufacturer or distributor of a dietary supplement...

21 CFR 111.535 - Under this subpart N, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements... material review and disposition decision on a returned dietary supplement; (3) The results of any testing... dietary supplement meets product specifications established in accordance with § 111.70(e). ...

21 CFR 111.260 - What must the batch record include?

Code of Federal Regulations, 2010 CFR

2010-04-01

..., LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements... dietary supplement; and (2) That you assign in accordance with § 111.415(f) for the following: (i) Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement; (ii...

Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

PubMed

Sax, Joanna K

2015-01-01

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Suspected dietary supplement injuries in special operations soldiers.

PubMed

Hughes, John; Shelton, Byron; Hughes, Teresa

2010-01-01

Evidence suggests that a number of Special Operations Soldiers are using dietary supplements to augment their physical training programs and that some of these supplements are not entirely benign. This article presents a series of case reports of Soldiers who suffered adverse effects that may be at least partially attributable to the use of dietary supplements. Given that many Special Operations Soldiers train at the same level as world class athletes and the use of supplements is common among world class athletes, the use of supplements is not likely to stop. To this end, the purpose of this article is to provide awareness of the problem, discuss some of the harmful effects of dietary supplements, make a recommendation for education to help reduce the number of injuries resulting from the use of dietary supplements, and recommend that scientific studies be done to prove the benefits and risks of taking dietary supplements. © 2010.

76 FR 32214 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-03

... a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to FDA upon which it has based its conclusion that a dietary supplement containing a new dietary... delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary...

78 FR 52773 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary... delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary...

Should You Take Dietary Supplements?

MedlinePlus

... August 2013 Print this issue Should You Take Dietary Supplements? A Look at Vitamins, Minerals, Botanicals and More ... half of all Americans take one or more dietary supplements daily or on occasion. Supplements are available without ...

Dental patients' self-reported use of dietary supplements on medical history questionnaires.

PubMed

Bakuri, Sarmad; Lanning, Sharon K; Best, Al M; Sabatini, Robert; Gunsolley, John; Waldrop, Thomas C

2016-01-01

Dietary supplement effects and drug interactions can lead to significant adverse health events, thus potentially impacting the safe delivery of oral healthcare. This study sought to determine the frequency of, and factors impacting, dietary supplement use among 209 dental patients and whether the design of a medical history questionnaire influences reporting of supplement use. Patients were randomly allocated to 1 of 2 groups in which they completed either a standard medical history questionnaire (n = 107) or the same questionnaire with an additional item about dietary supplement use (n = 102). All patients were then administered a survey with questions about their demographics, their use and knowledge of dietary supplements, and the person or persons who recommended dietary supplement use to the patient. While 62% of the total population (130/209) reported supplement use, specific prompting nearly doubled the number of supplements reported (mean with prompting: 1.53; mean without prompting: 0.76; P < 0.0001). Patients younger than 30 years of age reported significantly less dietary supplement use than all other age groups except the 30-40 age group (P = 0.0003). An estimated 70% of all respondents were not aware of potentially detrimental side effects of dietary supplement use or possible interactions with conventional drug therapies. Since patients tended to report a greater use of dietary supplements when specifically asked about their use on a medical history questionnaire, a checklist or set of designated questions may be a suitable first step toward gathering this essential information.

Antioxidant vitamins in the context of nonalcoholic fatty liver disease in obese children and adolescents

PubMed Central

Ued, Fábio da Veiga; Weffort, Virgínia Resende S.

2013-01-01

OBJECTIVE: To review the literature on the importance of antioxidant vitamins, analyzed in the context of dietary intake, its plasma levels, and its current use as a supplementation treatment in obese children and adolescents with nonalcoholic fatty liver disease. DATA SOURCES: The articles were identified in Lilacs, Ibecs, SciELO, PubMed/Medline, and Scopus databases. To conduct the survey, the "fatty liver" descriptor was associated to the following words: "children", "antioxidants" and "vitamins". The search was limited to articles written in Portuguese, Spanish and English, with publication date until December, 2012. DATA SYNTHESIS: Six studies were selected. The survey revealed a low dietary intake and low antioxidant vitamins serum levels in this population. The changes in lifestyle, with adequate dietary intake of vitamins, and the increase in physical activity were associated with a significant improvement in liver histology and in laboratory tests. Vitamin supplementation also improved the disease progression markers, as the alanine aminotransferase serum levels and the histological characteristics of lobular inflammation and hepatocellular damage. However, these improvements were not statistically significant in all studies. CONCLUSIONS: There is insufficient evidence to recommend or to refute antioxidant supplementation in patients with simple steatosis or steatohepatitis. The changes in lifestyle seem to be, at the present time, the more advisable therapy. PMID:24473959

Dietary supplements in the setting of mohs surgery.

PubMed

Collins, Siobhan C; Dufresne, Raymond G

2002-06-01

The use of dietary supplements has become increasingly popular. While many are safe in small doses, others may have potentially harmful effects, particularly in surgical patients. To study the incidence of dietary supplement use in patients presenting for Mohs surgery. One hundred consecutive patients presenting for Mohs surgery completed a questionnaire providing all current medications. During the consultation, the patients were then asked specifically about their current use of any dietary supplements. Responses differing from those on the questionnaire were recorded. Forty-nine of 100 patients (49%) were currently taking dietary supplements. Of this group, 17 patients (35%) self-reported the use of supplements; 32 patients (65%) did not. Thirty women (59%) were currently using dietary supplements regularly compared to 19 men (39%). Women were also more likely to self-report the use of supplements compared to men: 14 women (47%) versus three men (15%). Forty-eight of the 100 study patients (48%) were currently taking anticoagulant medications such as aspirin, warfarin, nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel bisulfate. Fifty instances were noted where patients were taking one or more dietary supplements that have demonstrated anticoagulant properties. Of this group, 21 instances (42%) where patients took a combination of prescription and over-the-counter (OTC) anticoagulants and one or more dietary supplements shown to have effects on coagulation were recorded. Of the almost 50% of patients taking dietary supplements, one-third reported usage, while two-thirds did not. Women used dietary supplements more frequently than men and were more than three times more likely to offer this information. Furthermore, many supplements have been shown to have effects on coagulation, including vitamin E, garlic, ginkgo, feverfew, and fish oils. Use of these substances alone or in combination may potentiate the anticoagulant effects of each other or prescribed medications. It is therefore important for the dermatologic surgeon to communicate openly with patients regarding dietary supplements to avoid potential complications during or following surgery.

Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study

PubMed Central

Block, Gladys; Jensen, Christopher D; Norkus, Edward P; Dalvi, Tapashi B; Wong, Les G; McManus, Jamie F; Hudes, Mark L

2007-01-01

Background Dietary supplement use in the United States is prevalent and represents an important source of nutrition. However, little is known about individuals who routinely consume multiple dietary supplements. This study describes the dietary supplement usage patterns, health, and nutritional status of long-term multiple dietary supplement users, and where possible makes comparisons to non-users and multivitamin/mineral supplement users. Methods Using a cross-sectional study design, information was obtained by online questionnaires and physical examination (fasting blood, blood pressure, body weight) from a convenience sample of long-term users of multiple dietary supplements manufactured by Shaklee Corporation (Multiple Supp users, n = 278). Data for non-users (No Supp users, n = 602) and multivitamin/mineral supplement users (Single Supp users, n = 176) were obtained from the National Health and Nutrition Examination Survey (NHANES) 2001–2002 and NHANES III 1988–1994. Logistic regression methods were used to estimate odds ratios with 95% confidence intervals. Results Dietary supplements consumed on a daily basis by more than 50% of Multiple Supp users included a multivitamin/mineral, B-complex, vitamin C, carotenoids, vitamin E, calcium with vitamin D, omega-3 fatty acids, flavonoids, lecithin, alfalfa, coenzyme Q10 with resveratrol, glucosamine, and a herbal immune supplement. The majority of women also consumed gamma linolenic acid and a probiotic supplement, whereas men also consumed zinc, garlic, saw palmetto, and a soy protein supplement. Serum nutrient concentrations generally increased with increasing dietary supplement use. After adjustment for age, gender, income, education and body mass index, greater degree of supplement use was associated with more favorable concentrations of serum homocysteine, C-reactive protein, high-density lipoprotein cholesterol, and triglycerides, as well as lower risk of prevalent elevated blood pressure and diabetes. Conclusion This group of long-term multiple dietary supplement users consumed a broad array of vitamin/mineral, herbal, and condition-specific dietary supplements on a daily basis. They were more likely to have optimal concentrations of chronic disease-related biomarkers, and less likely to have suboptimal blood nutrient concentrations, elevated blood pressure, and diabetes compared to non-users and multivitamin/mineral users. These findings should be confirmed by studying the dietary supplement usage patterns, health, and nutritional status of other groups of heavy users of dietary supplements. PMID:17958896

Dietary Crude Lecithin Increases Systemic Availability of Dietary Docosahexaenoic Acid with Combined Intake in Rats.

PubMed

van Wijk, Nick; Balvers, Martin; Cansev, Mehmet; Maher, Timothy J; Sijben, John W C; Broersen, Laus M

2016-07-01

Crude lecithin, a mixture of mainly phospholipids, potentially helps to increase the systemic availability of dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), such as docosahexaenoic acid (DHA). Nevertheless, no clear data exist on the effects of prolonged combined dietary supplementation of DHA and lecithin on RBC and plasma PUFA levels. In the current experiments, levels of DHA and choline, two dietary ingredients that enhance neuronal membrane formation and function, were determined in plasma and red blood cells (RBC) from rats after dietary supplementation of DHA-containing oils with and without concomitant dietary supplementation of crude lecithin for 2-3 weeks. The aim was to provide experimental evidence for the hypothesized additive effects of dietary lecithin (not containing any DHA) on top of dietary DHA on PUFA levels in plasma and RBC. Dietary supplementation of DHA-containing oils, either as vegetable algae oil or as fish oil, increased DHA, eicosapentaenoic acid (EPA), and total n-3 PUFA, and decreased total omega-6 PUFA levels in plasma and RBC, while dietary lecithin supplementation alone did not affect these levels. However, combined dietary supplementation of DHA and lecithin increased the changes induced by DHA supplementation alone. Animals receiving a lecithin-containing diet also had a higher plasma free choline concentration as compared to controls. In conclusion, dietary DHA-containing oils and crude lecithin have synergistic effects on increasing plasma and RBC n-3 PUFA levels, including DHA and EPA. By increasing the systemic availability of dietary DHA, dietary lecithin may increase the efficacy of DHA supplementation when their intake is combined.

Consumers' perceptions of the dietary supplement health and education act: implications and recommendations.

PubMed

Dodge, Tonya

2016-01-01

In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA). The regulatory framework for dietary supplements created by DSHEA has led to significant misperceptions regarding consumers' understanding of the safety and efficacy of supplements. Research shows that consumers erroneously believe that: (1) supplements are approved by the government, (2) supplements have been tested for safety and effectiveness, (3) the content of supplements is analyzed, and (4) manufacturers are required to disclose known adverse effects to consumers. Furthermore, labelling requirements that are intended to provide transparency to consumers are relatively ineffective. The following four recommendations are offered for reforming DSHEA: (1) only allow structure-function claims that are supported by research evidence, (2) require manufacturers to list known adverse effects on the labels of dietary supplements, (3) require that the Food and Drug Administration analyzes the content of dietary supplements and (4) restrict the definition of dietary ingredients. These recommendations would bring DSHEA to more closely align with consumer expectations regarding the regulation of dietary supplements and would likely provide a safer landscape for the use of supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

21 CFR 111.1 - Who is subject to this part?

Code of Federal Regulations, 2014 CFR

2014-04-01

... HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.1 Who is subject to this part? (a..., package, label, or hold a dietary supplement, including: (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and (2) A dietary supplement imported or offered for import...

21 CFR 111.1 - Who is subject to this part?

Code of Federal Regulations, 2012 CFR

2012-04-01

... HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.1 Who is subject to this part? (a..., package, label, or hold a dietary supplement, including: (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and (2) A dietary supplement imported or offered for import...

78 FR 68453 - Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

... Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug... Dietary Supplements--21 CFR 111.75(a)(1)(ii) (OMB Control Number 0910-0608)-- Extension The Dietary... supplements. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if ``it has...

21 CFR 111.113 - What quality control operations are required for a material review and disposition decision?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... that adulterates or may lead to adulteration of the component, dietary supplement, or packaging, or... or batches of a dietary supplement; or (5) A dietary supplement is returned. (b)(1) When there is a...

[Whether the advertisement of dietary supplements is objective source of data about their impact on health? Analysis of broadcasting advertisements in the terms of the food law].

PubMed

Wierzejska, Regina

2016-01-01

Dietary supplements are intensively advertised in the media. Due to their form analogous to drugs many people don't notice differences between them, although it is fundamental. The dietary supplement, as the category of food don't have medicinal properties and suggesting such properties by producers is forbidden. The aim of this study was analysis of advertisements of dietary supplements, transmitted in the media in accordance with the law requirements, especially with the conditions of nutrition and health claims established in 2012. Advertisements of dietary supplements, transmitted in the period of one week (17-23 of September 2014 r.) into 5 radio and television channels. In the analysed period commercials of 27 assortments of the dietary supplement were being transmitted. Advertisements of 23 of them declared improvement the action of organs or concentration of biochemical indicators in the body. The strength of declarations about the benefits of action of dietary supplements was diversified, from expressions such as "support" to "treat" and "prevent". In some advertisements the authority of medical profession was being used. Moreover many advertisements emphasized the unique and comprehensive active ingredients of dietary supplement on the market. Advertisements of dietary supplements promise beneficial effect to the human body. In spite of more and more detailed legal requirements many of them are going beyond conditions established for food. It can cause incorrect opinion about the role of dietary supplements in curing medical disorders.

Prevalence, Knowledge and Attitudes Concerning Dietary Supplements among a Student Population in Croatia.

PubMed

Žeželj, Sandra Pavičić; Tomljanović, Ana; Jovanović, Gordana Kenđel; Krešić, Greta; Peloza, Olga Cvijanović; Dragaš-Zubalj, Nataša; Prokurica, Iva Pavlinić

2018-05-23

The aim of this study was to determine the prevalence of usage and the knowledge and attitudes towards dietary supplements among medical sciences and nonmedical sciences students from Croatia. The study was conducted based on a questionnaire about dietary supplement usage, knowledge and attitudes. The prevalence of dietary supplement use, among 910 university students was 30.5%. The most-used dietary supplements were vitamins (18.0% in medical sciences students and 9.8% in non-medical sciences students). For all students, the internet (66.1%) was the most common source of information, followed by healthcare professionals (33.2%). The most common reason for taking dietary supplements was to maintain good health (26.4%). Use of the internet rather than health professionals as a trusted information source should be revised among this young population. Supplement intake was significantly associated with body mass index (BMI) ( p = 0.016) and physical activity ( p = 0.050). Students with normal BMI (61.5%) and the most physically active students (37.7%) took significantly more dietary supplements. Results of this study could help medicine faculties to improve their curriculum and support the development of public health messages aimed at wise and safe use of dietary supplements.

Dietary Supplement Adverse Event Report Data From the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013.

PubMed

Timbo, Babgaleh B; Chirtel, Stuart J; Ihrie, John; Oladipo, Taiye; Velez-Suarez, Loy; Brewer, Vickery; Mozersky, Robert

2018-05-01

The Food and Drug Administration (FDA)'s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety of the nation's foods, dietary supplements, and cosmetic products. To present a descriptive analysis of the 2004-2013 dietary supplement adverse event report (AER) data from CAERS and evaluate the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act as pertaining to dietary supplements adverse events reporting. We queried CAERS for data from the 2004-2013 AERs specifying at least 1 suspected dietary supplement product. We extracted the product name(s), the symptom(s) reported, age, sex, and serious adverse event outcomes. We examined time trends for mandatory and voluntary reporting and performed analysis using SAS v9.4 and R v3.3.0 software. Of the total AERs (n = 15 430) received from January 1, 2004, through December 31, 2013, indicating at least 1 suspected dietary supplement product, 66.9% were mandatory, 32.2% were voluntary, and 0.9% were both mandatory and voluntary. Reported serious outcomes included death, life-threatening conditions, hospitalizations, congenital anomalies/birth defects and events requiring interventions to prevent permanent impairments (5.1%). The dietary supplement adverse event reporting rate in the United States was estimated at ~2% based on CAERS data. This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 period and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

Prevalence, Adverse Events, and Factors Associated with Dietary Supplement and Nutritional Supplement Use by US Navy and Marine Corps Personnel.

PubMed

Knapik, Joseph J; Trone, Daniel W; Austin, Krista G; Steelman, Ryan A; Farina, Emily K; Lieberman, Harris R

2016-09-01

About 50% of Americans and 60% to 70% of US military personnel use dietary supplements, some of which have been associated with adverse events (AEs). Nutritional supplements like sport drinks and sport bars/gels are also commonly used by athletes and service members. Previous dietary supplement and nutritional supplement surveys were conducted on Army, Air Force, and Coast Guard personnel. The aim of this cross-sectional study was to investigate dietary and nutritional supplement use in Navy and Marine Corps personnel, including the prevalence, types, factors associated with use, and AEs. A random sample of 10,000 Navy and Marine Corps personnel were contacted. Service members were asked to complete a detailed questionnaire describing their personal characteristics, supplement use, and AEs experienced. In total, 1,708 service members completed the questionnaire during August through December 2014, with 1,683 used for analysis. Overall, 73% reported using dietary supplements one or more times per week. The most commonly used dietary supplements (used one or more times per week) were multivitamins/multiminerals (48%), protein/amino acids (34%), combination products (33%), and individual vitamins and minerals (29%). About 31% of service members reported using five or more dietary supplements. Sport drinks and sport bars/gels were used by 45% and 23% of service members, respectively. Monthly expenditures on dietary supplements averaged $39; 31% of service members spent ≥$50/mo. Multivariate logistic regression modeling indicated that female sex (women/men; odds ratio [OR]=1.76, 95% CI 1.32 to 2.36), higher educational level (college degree/no college degree; OR=2.23, 95% CI 1.62 to 3.30), higher body mass index (calculated as kg/m(2)) (≥30/<25; OR=1.67, 95% CI 1.06 to 2.63), and a greater amount of resistance training (≥271/0 to 45 min/week; OR=2.85, 95% CI 1.94 to 4.17) were associated with dietary supplement use. Twenty-two percent of dietary supplement users and 6% of nutritional supplement users reported one or more AEs. For combination products alone, 29% of users reported one or more AEs. The prevalence of dietary supplement use in Navy and Marine Corps personnel was considerably higher than reported in civilian investigations for almost all types of dietary supplements, although similar to most other military services. Factors associated with dietary supplement use were similar to those reported in previous military and civilian investigations. Prevalence of self-reported AEs was very high, especially for combination products. Published by Elsevier Inc.

Culinary Spice Plants in Dietary Supplement Products and Tested in Clinical Trials123

PubMed Central

Saldanha, Leila G; Dwyer, Johanna T; Betz, Joseph M

2016-01-01

Dried plant parts used as culinary spices (CSs) in food are permitted as dietary ingredients in dietary supplements (DSs) within certain constraints in the United States. We reviewed the amounts, forms, and nutritional support (structure/function) claims of DSs that contain CS plants listed in the Dietary Supplement Label Database (DSLD) and compared this label information with trial doses and health endpoints for CS plants that were the subject of clinical trials listed in clinicaltrials.gov. According to the DSLD, the CS plants occurring most frequently in DSs were cayenne, cinnamon, garlic, ginger, pepper, rosemary, and turmeric. Identifying the botanical species, categorizing the forms used, and determining the amounts from the information provided on DS labels was challenging. CS plants were typically added as a component of a blend, as the powered biomass, dried extracts, and isolated phytochemicals. The amounts added were declared on about 55% of the labels, rendering it difficult to determine the amount of the CS plant used in many DSs. Clinicaltrials.gov provided little information about the composition of test articles in the intervention studies. When plant names were listed on DS labels and in clinical trials, generally the common name and not the Latin binomial name was given. In order to arrive at exposure estimates and enable researchers to reproduce clinical trials, the Latin binomial name, form, and amount of the CS plant used in DSs and tested in clinical trials must be specified. PMID:26980817

Culinary Spice Plants in Dietary Supplement Products and Tested in Clinical Trials.

PubMed

Saldanha, Leila G; Dwyer, Johanna T; Betz, Joseph M

2016-03-01

Dried plant parts used as culinary spices (CSs) in food are permitted as dietary ingredients in dietary supplements (DSs) within certain constraints in the United States. We reviewed the amounts, forms, and nutritional support (structure/function) claims of DSs that contain CS plants listed in the Dietary Supplement Label Database (DSLD) and compared this label information with trial doses and health endpoints for CS plants that were the subject of clinical trials listed in clinicaltrials.gov. According to the DSLD, the CS plants occurring most frequently in DSs were cayenne, cinnamon, garlic, ginger, pepper, rosemary, and turmeric. Identifying the botanical species, categorizing the forms used, and determining the amounts from the information provided on DS labels was challenging. CS plants were typically added as a component of a blend, as the powered biomass, dried extracts, and isolated phytochemicals. The amounts added were declared on about 55% of the labels, rendering it difficult to determine the amount of the CS plant used in many DSs. Clinicaltrials.gov provided little information about the composition of test articles in the intervention studies. When plant names were listed on DS labels and in clinical trials, generally the common name and not the Latin binomial name was given. In order to arrive at exposure estimates and enable researchers to reproduce clinical trials, the Latin binomial name, form, and amount of the CS plant used in DSs and tested in clinical trials must be specified. © 2016 American Society for Nutrition.

21 CFR 190.6 - Requirement for premarket notification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) DIETARY SUPPLEMENTS New Dietary Ingredient Notification § 190.6 Requirement for premarket... dietary supplement that contains a new dietary ingredient that has not been present in the food supply as... manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of...

A content analysis of the quantity and accuracy of dietary supplement information found in magazines with high adolescent readership.

PubMed

Shaw, Patricia; Zhang, Vivien; Metallinos-Katsaras, Elizabeth

2009-02-01

The objective of this study was to examine the quantity and accuracy of dietary supplement (DS) information through magazines with high adolescent readership. Eight (8) magazines (3 teen and 5 adult with high teen readership) were selected. A content analysis for DS was conducted on advertisements and editorials (i.e., articles, advice columns, and bulletins). Noted claims/cautions regarding DS were evaluated for accuracy using Medlineplus.gov and Naturaldatabase.com. Claims for dietary supplements with three or more types of ingredients and those in advertisements were not evaluated. Advertisements were evaluated with respect to size, referenced research, testimonials, and Dietary Supplement Health and Education Act of 1994 (DSHEA) warning visibility. Eighty-eight (88) issues from eight magazines yielded 238 DS references. Fifty (50) issues from five magazines contained no DS reference. Among teen magazines, seven DS references were found: five in the editorials and two in advertisements. In adult magazines, 231 DS references were found: 139 in editorials and 92 in advertisements. Of the 88 claims evaluated, 15% were accurate, 23% were inconclusive, 3% were inaccurate, 5% were partially accurate, and 55% were unsubstantiated (i.e., not listed in reference databases). Of the 94 DS evaluated in advertisements, 43% were full page or more, 79% did not have a DSHEA warning visible, 46% referred to research, and 32% used testimonials. Teen magazines contain few references to DS, none accurate. Adult magazines that have a high teen readership contain a substantial amount of DS information with questionable accuracy, raising concerns that this information may increase the chances of inappropriate DS use by adolescents, thereby increasing the potential for unexpected effects or possible harm.

Trends in Vitamin A, C, D, E, K Supplement Prescriptions From Military Treatment Facilities: 2007 to 2011.

PubMed

Morioka, Travis Y; Bolin, Jeremy T; Attipoe, Selasi; Jones, Donnamaria R; Stephens, Mark B; Deuster, Patricia A

2015-07-01

Although prior studies have examined the prevalence of dietary supplement use among various populations, data on single vitamins prescribed by health care providers are limited. This study examined trends in single-vitamin supplement (A, C, D, E, K) prescriptions by providers from military treatment facilities from 2007 to 2011. We examined prescription data from the Department of Defense Pharmacy Data Transaction Service to determine trends in the aforementioned single-vitamin supplement prescriptions. Prescription rates per 1,000 active duty personnel were estimated using population data retrieved from the Defense Medical Epidemiology Database (i.e., [number of prescriptions/population size] × 1,000). Across the 5-year period, the number of vitamin D prescriptions per 1,000 active duty personnel increased 454%. In contrast, the number of vitamin A, vitamin E, and vitamin K prescriptions per 1,000 active duty personnel decreased by 32%, 53%, and 29% respectively. Vitamin C prescriptions remained relatively constant. Across all age groups, total single-vitamin supplement prescriptions increased by 180%. Together, prescriptions examined in this study increased steadily from 2007 to 2011, primarily because of the increase in vitamin D prescriptions. The exhibited trend reflects the current general-population pattern of dietary supplement use, with large increases in vitamin D and declines in vitamin E. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Thyrotoxic hypokalemic periodic paralysis due to dietary weight-loss supplement.

PubMed

Akinyemi, Emmanuel; Bercovici, Silvia; Niranjan, Selvanayagam; Paul, Nisha; Hemavathy, Bhakthavatsalam

2011-05-01

Herbal and dietary supplements for weight loss and in treatment of obesity are growing in popularity and acceptance in the United States. Most of these supplements can be obtained over the counter and can have serious adverse effects associated with their consumption. We describe 2 patients who developed thyrotoxic hypokalemic periodic paralysis 2-3 weeks after consuming thyroxine-containing weight-loss supplements. This is the first known case of thyrotoxic hypokalemic periodic paralysis secondary to dietary supplements. It is important that patients and physicians are aware of the severe adverse reactions associated with dietary supplements. Physicians should as a routine inquire about herbal and dietary supplement consumption during all patient encounters.

Safety assessment of mushrooms in dietary supplements by combining analytical data with in silico toxicology evaluation.

PubMed

VanderMolen, Karen M; Little, Jason G; Sica, Vincent P; El-Elimat, Tamam; Raja, Huzefa A; Oberlies, Nicholas H; Baker, Timothy R; Mahony, Catherine

2017-05-01

Despite growing popularity in dietary supplements, many medicinal mushrooms have not been evaluated for their safe human consumption using modern techniques. The multifaceted approach described here relies on five key principles to evaluate the safety of non-culinary fungi for human use: (1) identification by sequencing the nuclear ribosomal internal transcribed spacer (ITS) region (commonly referred to as ITS barcoding), (2) screening an extract of each fungal raw material against a database of known fungal metabolites, (3) comparison of these extracts to those prepared from grocery store-bought culinary mushrooms using UHPLCPDA-ELS-HRMS, (4) review of the toxicological and chemical literature for each fungus, and (5) evaluation of data establishing presence in-market. This weight-of-evidence approach was used to evaluate seven fungal raw materials and determine safe human use for each. Such an approach may provide an effective alternative to conventional toxicological animal studies (or more efficiently identifies when studies are necessary) for the safety assessment of fungal dietary ingredients. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2011 CFR

2011-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2013 CFR

2013-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2012 CFR

2012-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2012 CFR

2012-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2011 CFR

2011-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2014 CFR

2014-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2013 CFR

2013-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2010 CFR

2010-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

Consumer attitudes about the role of multivitamins and other dietary supplements: report of a survey.

PubMed

Dickinson, Annette; MacKay, Douglas; Wong, Andrea

2015-07-02

U.S. nutrition surveys find that intakes of many nutrients fall short of recommendations. The majority of U.S. adults use multivitamins and other dietary supplements as one means of improving nutrient intakes. Some policy makers and health professionals appear reluctant to recommend routine use of dietary supplements to fill nutrient gaps in the diet, in part because they are concerned that people will view the supplements as a substitute for dietary improvement and that the use of supplements may lead to overconsumption of micronutrients. Surveys find that in fact users of dietary supplements tend to have better diets and adopt other healthy habits, suggesting that the supplements are viewed as one aspect of an overall effort to improve wellness. Furthermore, evidence demonstrates that the incidence of excess micronutrient intake is low. We report the results of a survey probing consumer attitudes about the role of dietary supplements. The Council for Responsible Nutrition funded a survey to measure consumer attitudes about the role of multivitamins, calcium and/or vitamin D supplements, and other supplements in improving dietary intakes. The research was designed and analyzed by FoodMinds and was fielded using Toluna's On-line Omnibus. The weighted sample of 2159 respondents is representative of U.S. adults. Nearly 90% of the survey respondents agreed that multivitamins and supplements of calcium and/or vitamin D can help meet nutrient needs when desirable intakes are not achieved through food alone. At the same time, 80% agreed that dietary supplements should not be used to replace healthy dietary or lifestyle habits, and 82% agreed that people considering taking a high dose, single nutrient supplement should talk with their physician. These results provide additional support for the conclusion that the vast majority of consumers recognize that multivitamins and other supplements can help fill nutrient gaps but should not be viewed as replacements for a healthy diet. This suggests that policy makers and health professionals could feel comfortable recommending rational dietary supplementation as one means of improving nutrient intakes, without being unduly concerned that such a recommendation would lead consumers to discount the importance of good dietary habits.

77 FR 35687 - Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer... of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) and the...

Complementarity in dietary supplements and foods: are supplement users vegetable eaters?

PubMed

Kang, Hyoung-Goo; Joo, Hailey Hayeon; Choi, Kyong Duk; Lee, Dongmin; Moon, Junghoon

2017-01-01

Background : The consumption of fruits, vegetables, and dietary supplements correlate. Most previous studies have aimed to identify the determinants of supplement uses or the distinct features of supplement users; this literature lacks a discussion on dietary supplement consumption as a predictor of fruit and vegetable consumption. Objective : This study examines how dietary supplement consumption correlates with fruit and vegetable consumption by combining scanner data and surveys of Korean household grocery shopping. Methods : Propensity score matching (PSM) is used to identify the relationship between dietary supplement consumption and fruit and vegetable consumption in a household. A logit regression using supplement consumption as the dependent variable is used. Then, the supplement takers (the treatment group) are matched with non-takers (the control group) based on the propensity scores estimated in the logit regression. The fruit and vegetable consumption levels of the groups are then compared. Results : We found that dietary supplement use is associated with higher fruit and vegetable consumption. This supports the health consciousness hypothesis based on attention bias, availability heuristics, the focusing effect, and the consumption episode effect. It rejects the health substitute hypothesis based on economic substitutes and mental accounting. Conclusions : Future research on the health benefits of dietary supplements should address the complementary consumption of fruits/vegetables and their health benefits to avoid misstating the health effects of supplements.

Complementarity in dietary supplements and foods: are supplement users vegetable eaters?

PubMed Central

Kang, Hyoung-Goo; Joo, Hailey Hayeon; Choi, Kyong Duk; Lee, Dongmin; Moon, Junghoon

2017-01-01

ABSTRACT Background: The consumption of fruits, vegetables, and dietary supplements correlate. Most previous studies have aimed to identify the determinants of supplement uses or the distinct features of supplement users; this literature lacks a discussion on dietary supplement consumption as a predictor of fruit and vegetable consumption. Objective: This study examines how dietary supplement consumption correlates with fruit and vegetable consumption by combining scanner data and surveys of Korean household grocery shopping. Methods: Propensity score matching (PSM) is used to identify the relationship between dietary supplement consumption and fruit and vegetable consumption in a household. A logit regression using supplement consumption as the dependent variable is used. Then, the supplement takers (the treatment group) are matched with non-takers (the control group) based on the propensity scores estimated in the logit regression. The fruit and vegetable consumption levels of the groups are then compared. Results: We found that dietary supplement use is associated with higher fruit and vegetable consumption. This supports the health consciousness hypothesis based on attention bias, availability heuristics, the focusing effect, and the consumption episode effect. It rejects the health substitute hypothesis based on economic substitutes and mental accounting. Conclusions: Future research on the health benefits of dietary supplements should address the complementary consumption of fruits/vegetables and their health benefits to avoid misstating the health effects of supplements. PMID:28904529

Dangerous dietary supplements: Garcinia cambogia-associated hepatic failure requiring transplantation.

PubMed

Lunsford, Keri E; Bodzin, Adam S; Reino, Diego C; Wang, Hanlin L; Busuttil, Ronald W

2016-12-07

Commercial dietary supplements are marketed as a panacea for the morbidly obese seeking sustainable weight-loss. Unfortunately, many claims cited by supplements are unsupported and inadequately regulated. Most concerning, however, are the associated harmful side effects, often unrecognized by consumers. Garcinia cambogia extract and Garcinia cambogia containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we report the first known case of fulminant hepatic failure associated with this dietary supplement. One active ingredient in this supplement is hydroxycitric acid, an active ingredient also found in weight-loss supplements banned by the Food and Drug Administration in 2009 for hepatotoxicity. Heightened awareness of the dangers of dietary supplements such as Garcinia cambogia is imperative to prevent hepatoxicity and potential fulminant hepatic failure in additional patients.

Exploring beliefs about dietary supplement use: focus group discussions with Dutch adults.

PubMed

Pajor, Emília Margit; Oenema, Anke; Eggers, Sander Matthijs; de Vries, Hein

2017-10-01

Although dietary supplement use is increasing in Europe and the USA, little research involving adults' beliefs regarding dietary supplements has been conducted. Therefore, the present study aimed to explore and compare users' and non-users' beliefs towards dietary supplements. Thirteen focus group discussions were conducted of which seven groups were dietary supplement users and six groups were non-users. Based on the socio-cognitive factors of the Integrated Change Model, a semi-structured topic guide was set up. The discussions were audio-recorded and subjected to qualitative content analysis, applying the framework approach. Data were collected in Maastricht, the Netherlands, in 2014 and 2015. In total fifty-six individuals participated in the study, of whom twenty-eight were dietary supplement users and twenty-eight non-users. The average age of participants was 42·9 years. Dietary supplement users' attitude beliefs were mainly related to mental and physical health enhancement, illness prevention and curative health benefits. Users were critical of the nutritional knowledge of health professionals and of the quality of food products. Non-users were convinced that the human body does not need any support and that regular food is enough to cover one's nutritional needs. Users and non-users held comparable beliefs regarding the definition and risks of dietary supplements, and perceived social influences. In their decision about dietary supplement use, both groups were guided by their own convictions to a great extent. Both groups would benefit from improved understanding of the health effects of dietary supplements to improve informed decision making.

Determinants of the use of dietary supplements among secondary and high school students

PubMed

Gajda, Karolina; Zielińska, Monika; Ciecierska, Anna; Hamułka, Jadwiga

All over the world, including Poland, the sale of dietary supplements is increasing. More and more often, people including children and youths, use dietary supplements on their own initiative and without any medical indications or knowledge in this field. Analysis of the conditions of using the dietary supplements with vitamins and minerals among secondary school and high school students in Poland. The study included 396 students aged 13-18 years (249 girls and 147 boys). Authors’ questionnaire was used to evaluate the intake of dietary supplements. The use of cluster analysis allowed to distinguish groups of students with similar socio-demographic characteristics and the frequency of use of dietary supplements. In the studied population of students three clusters were created that significantly differed in socio-demographic characteristics. In cluster 1 and 2, were mostly students who used dietary supplements (respectively, 56% of respondents and 100%). In cluster 1 there were mostly students coming from rural areas and small city, with a worse financial situation, mainly boys (56%), while cluster 2 was dominated by girls (81%) living in a big city, coming from families with a good financial situation and who were more likely to be underweight (28.8%). In cluster 3 there were mostly older students (62%), not taking dietary supplements. In comparison to cluster 2, they had lower frequency of breakfast consumption (55% vs. 69%), but higher frequency of the consumption of soft drinks, fast-food, coffee as well as salt use at the table. The results show that the use of dietary supplements in adolescence is a common phenomenon and slightly conditioned by eating behaviors. This unfavorable habit of common dietary supplements intake observed among students indicates the need for education on the benefits and risks of the supplements usage.

Nutrient intake and use of dietary supplements among US adults with disabilities.

PubMed

An, Ruopeng; Chiu, Chung-Yi; Andrade, Flavia

2015-04-01

Physical, mental, social, and financial hurdles in adults with disabilities may limit their access to adequate nutrition. To examine the impact of dietary supplement use on daily total nutrient intake levels among US adults 20 years and older with disabilities. Study sample came from 2007-2008 and 2009-2010 waves of the National Health and Nutrition Examination Survey, a nationally representative repeated cross-sectional survey. Disability was classified into 5 categories using standardized indices. Nutrient intakes from foods and dietary supplements were calculated from 2 nonconsecutive 24-hour dietary recalls. Two-sample proportion tests and multiple logistic regressions were used to examine the adherence rates to the recommended daily nutrient intake levels between dietary supplement users and nonusers in each disability category. The association between sociodemographic characteristics and dietary supplement use was assessed using multiple logistic regressions, accounting for complex survey design. A substantial proportion of the US adult population with disabilities failed to meet dietary guidelines, with insufficient intakes of multiple nutrients. Over half of the US adults with disabilities used dietary supplements. Dietary supplement use was associated with higher adherence rates for vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, calcium, copper, iron, magnesium, and zinc intake among adults with disabilities. Women, non-Hispanic Whites, older age, higher education, and higher household income were found to predict dietary supplement use. Proper use of dietary supplements under the guidance of health care providers may improve the nutritional status among adults with disabilities. Copyright © 2015 Elsevier Inc. All rights reserved.

Health habits and other characteristics of dietary supplement users: a review

PubMed Central

2014-01-01

Dietary supplements are used by half to two-thirds of American adults, and the evidence suggests that this usage is one component of a larger effort to develop a healthier lifestyle. Dietary supplement users tend on average to be better educated and to have somewhat higher incomes than nonusers, and these factors may contribute to their health-consciousness. Dietary supplement use also tends to be more prevalent among women than among men, and the prevalence of use increases with age in both men and women. Numerous surveys document that users of dietary supplements are significantly more likely than nonusers to have somewhat better dietary patterns, exercise regularly, maintain a healthy weight, and avoid tobacco products. While supplement users tend to have better diets than nonusers, the differences are relatively small, their diets have some substantial nutrient shortfalls, and their supplement use has been shown to improve the adequacy of nutrient intakes. Overall, the evidence suggests that users of dietary supplements are seeking wellness and are consciously adopting a variety of lifestyle habits that they consider to contribute to healthy living. PMID:24499096

Dietary Intake of Competitive Bodybuilders.

PubMed

Spendlove, Jessica; Mitchell, Lachlan; Gifford, Janelle; Hackett, Daniel; Slater, Gary; Cobley, Stephen; O'Connor, Helen

2015-07-01

Competitive bodybuilders are well known for extreme physique traits and extremes in diet and training manipulation to optimize lean mass and achieve a low body fat. Although many of the dietary dogmas in bodybuilding lack scientific scrutiny, a number, including timing and dosing of high biological value proteins across the day, have more recently been confirmed as effective by empirical research studies. A more comprehensive understanding of the dietary intakes of bodybuilders has the potential to uncover other dietary approaches, deserving of scientific investigation, with application to the wider sporting, and potential health contexts, where manipulation of physique traits is desired. Our objective was to conduct a systematic review of dietary intake practices of competitive bodybuilders, evaluate the quality and currency of the existing literature, and identify research gaps to inform future studies. A systematic search of electronic databases was conducted from the earliest record until March 2014. The search combined permutations of the terms 'bodybuilding', 'dietary intake', and 'dietary supplement'. Included studies needed to report quantitative data (energy and macronutrients at a minimum) on habitual dietary intake of competitive bodybuilders. The 18 manuscripts meeting eligibility criteria reported on 385 participants (n = 62 women). Most studies were published in the 1980-1990s, with three published in the past 5 years. Study methodological quality was evaluated as poor. Energy intake ranged from 10 to 24 MJ/day for men and from 4 to 14 MJ/day for women. Protein intake ranged from 1.9 to 4.3 g/kg for men and from 0.8 to 2.8 g/kg for women. Intake of carbohydrate and fat was <6 g/kg/day and below 30% of energy, respectively. Carbohydrate intakes were below, and protein (in men) intakes were higher than, the current recommendations for strength athletes, with no consideration for exploration of macronutrient quality or distribution over the day. Energy intakes varied over different phases of preparation, typically being highest in the non-competition (>6 months from competition) or immediate post-competition period and lowest during competition preparation (≤6 months from competition) or competition week. The most commonly reported dietary supplements were protein powders/liquids and amino acids. The studies failed to provide details on rationale for different dietary intakes. The contribution of diet supplements was also often not reported. When supplements were reported, intakes of some micronutrients were excessive (~1000% of US Recommended Dietary Allowance) and above the tolerable upper limit. This review demonstrates that literature describing the dietary intake practices of competitive bodybuilders is dated and often of poor quality. Intake reporting required better specificity and details of the rationale underpinning the use. The review suggests that high-quality contemporary research is needed in this area, with the potential to uncover dietary strategies worthy of scientific exploration.

Surveillance of the armed forces as a sentinel system for detecting adverse effects of dietary supplements in the general population.

PubMed

Lieberman, Harris R; Austin, Krista G; Farina, Emily K

2018-04-01

Half the US population takes dietary supplements, but surveillance systems available to regulatory and public health authorities to determine whether specific dietary supplements present a risk are inadequate and numerous severe injuries and deaths have occurred from their consumption. Uniformed military personnel regularly use dietary supplements and are more likely to use potentially dangerous supplements than civilians. Recently, the supplement 1,3-dimethylamylamine (DMAA) was marketed for physical performance-enhancement and weight loss. However, after over 100 reports of illness attributed to DMAA, including six deaths, the Food and Drug Administration issued a warning to cease its sale. When DMAA was legal (2010-2011), we conducted, using convenience samples, supplement surveys of service members and determined prevalence of use and self-reported symptoms of DMAA use. We surveyed 4374 armed forces personnel using a standardized dietary supplement survey administered by local health-care professionals. Overall, 11 % of survey respondents used dietary supplements labelled as containing DMAA at least once/week. Regular users were over two times more likely to report tachycardia (P<0·0001), tremors (P<0·0001) and dizziness (P=0·0004), and over three times more likely to report numbness/tingling (P<0·0001) than non-users. Military services could readily monitor adverse events associated with dietary supplements using electronic surveys and medical records. Since armed forces personnel are much more likely than civilians to use potentially dangerous dietary supplements like DMAA, near real-time surveillance of them using electronic surveys and medical records would provide early warning to regulatory agencies and the medical and public health communities when high-risk dietary supplements are introduced.

DNA Barcode Authentication of Saw Palmetto Herbal Dietary Supplements

PubMed Central

Little, Damon P.; Jeanson, Marc L.

2013-01-01

Herbal dietary supplements made from saw palmetto (Serenoa repens; Arecaceae) fruit are commonly consumed to ameliorate benign prostate hyperplasia. A novel DNA mini–barcode assay to accurately identify [specificity = 1.00 (95% confidence interval = 0.74–1.00); sensitivity = 1.00 (95% confidence interval = 0.66–1.00); n = 31] saw palmetto dietary supplements was designed from a DNA barcode reference library created for this purpose. The mini–barcodes were used to estimate the frequency of mislabeled saw palmetto herbal dietary supplements on the market in the United States of America. Of the 37 supplements examined, amplifiable DNA could be extracted from 34 (92%). Mini–barcode analysis of these supplements demonstrated that 29 (85%) contain saw palmetto and that 2 (6%) supplements contain related species that cannot be legally sold as herbal dietary supplements in the United States of America. The identity of 3 (9%) supplements could not be conclusively determined. PMID:24343362

DNA barcode authentication of saw palmetto herbal dietary supplements.

PubMed

Little, Damon P; Jeanson, Marc L

2013-12-17

Herbal dietary supplements made from saw palmetto (Serenoa repens; Arecaceae) fruit are commonly consumed to ameliorate benign prostate hyperplasia. A novel DNA mini-barcode assay to accurately identify [specificity = 1.00 (95% confidence interval = 0.74-1.00); sensitivity = 1.00 (95% confidence interval = 0.66-1.00); n = 31] saw palmetto dietary supplements was designed from a DNA barcode reference library created for this purpose. The mini-barcodes were used to estimate the frequency of mislabeled saw palmetto herbal dietary supplements on the market in the United States of America. Of the 37 supplements examined, amplifiable DNA could be extracted from 34 (92%). Mini-barcode analysis of these supplements demonstrated that 29 (85%) contain saw palmetto and that 2 (6%) supplements contain related species that cannot be legally sold as herbal dietary supplements in the United States of America. The identity of 3 (9%) supplements could not be conclusively determined.

Should states and local governments regulate dietary supplements?

PubMed

Starr, Ranjani

2016-01-01

Federal regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act of 1994. The law has been criticized as weak and ineffective. Alarming research has emerged demonstrating that supplements may be mislabelled, contaminated, adulterated with dangerous or unknown compounds, or sold at toxic doses. As a result, the health community has raised concerns about the safety and quality of dietary supplements. Increased federal oversight is an important avenue for improving supplement safety; however, states and local governments may also pursue strategies to strengthen the overall regulatory control of dietary supplements. States and local governments have substantial experience in regulating other products that pose a risk to public health, such as tobacco. Additionally, much has been learned about the tactics the tobacco industry has employed to protect its interests. Lessons learned may be applied to new regulatory efforts aimed at improving the safety of dietary supplements at the state and local levels. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Dietary Supplements Contribute Substantially to the Total Nutrient Intake in Pregnant Norwegian Women

PubMed Central

Haugen, Margaretha; Brantsæter, Anne Lise; Alexander, Jan; Meltzer, Helle Margrete

2008-01-01

Background Use of dietary supplements during pregnancy may give an important contribution to nutrient intake, and for nutrients like folate and vitamin D supplements are recommended. Our objective was to study use and contribution of dietary supplement to nutrient intake among women participating in the Norwegian Mother and Child Cohort Study (MoBa). Methods This study is based on 40,108 women participating in MoBa which is conducted by the Norwegian Institute of Public Health. The women had filled inversion 2 of the food frequency questionnaire in MoBa between February 2002 and February 2005. Results 81% reported use of one or more dietary supplements. The most commonly used category was cod liver oil/fish oil supplements (59%) followed by singular folic acid supplements (36%) and multivitamin/multimineral supplements (31%). The nutrient contribution of the dietary supplements varied from 65% for folate and vitamin D to 1% for potassium among supplement users. The dietary intake of vitamin D, folate, iodine and iron did not reach the Nordic Recommendations for pregnant women. Conclusions Use of supplements improved the intake of folate, iron and vitamin D, but not sufficiently to reach the recommended amounts. PMID:18645244

Dietary Supplements

MedlinePlus

Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, ... possible Tell your health care provider about any dietary supplements you use Do not take a bigger dose ...

Safety and performance benefits of arginine supplements for military personnel: a systematic review.

PubMed

Brooks, James R; Oketch-Rabah, Hellen; Low Dog, Tieraona; Gorecki, Dennis K J; Barrett, Marilyn L; Cantilena, Louis; Chung, Mei; Costello, Rebecca B; Dwyer, Johanna; Hardy, Mary L; Jordan, Scott A; Maughan, Ronald J; Marles, Robin J; Osterberg, Robert E; Rodda, Bruce E; Wolfe, Robert R; Zuniga, Jorge M; Valerio, Luis G; Jones, Donnamaria; Deuster, Patricia; Giancaspro, Gabriel I; Sarma, Nandakumara D

2016-11-01

Dietary supplements are widely used by military personnel and civilians for promotion of health. The objective of this evidence-based review was to examine whether supplementation with l-arginine, in combination with caffeine and/or creatine, is safe and whether it enhances athletic performance or improves recovery from exhaustion for military personnel. Information from clinical trials and adverse event reports were collected from 17 databases and 5 adverse event report portals. Studies and reports were included if they evaluated the safety and the putative outcomes of enhanced performance or improved recovery from exhaustion associated with the intake of arginine alone or in combination with caffeine and/or creatine in healthy adults aged 19 to 50 years. Information related to population, intervention, comparator, and outcomes was abstracted. Of the 2687 articles screened, 62 articles meeting the inclusion criteria were analyzed. Strength of evidence was assessed in terms of risk of bias, consistency, directness, and precision. Most studies had few participants and suggested risk of bias that could negatively affect the results. l-Arginine supplementation provided little enhancement of athletic performance or improvements in recovery. Short-term supplementation with arginine may result in adverse gastrointestinal and cardiovascular effects. No information about the effects of arginine on the performance of military personnel was available. The available information does not support the use of l-arginine, either alone or in combination with caffeine, creatine, or both, to enhance athletic performance or improve recovery from exhaustion. Given the information gaps, an evidence-based review to assess the safety or effectiveness of multi-ingredient dietary supplements was not feasible, and therefore the development of a computational model-based approach to predict the safety of multi-ingredient dietary supplements is recommended. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

21 CFR 111.30 - What requirements apply to automated, mechanical, or electronic equipment?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and... dietary supplement, you must: (a) Design or select equipment to ensure that dietary supplement...

21 CFR 111.30 - What requirements apply to automated, mechanical, or electronic equipment?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and... dietary supplement, you must: (a) Design or select equipment to ensure that dietary supplement...

Multivitamin-multimineral supplements: who uses them?

PubMed

Rock, Cheryl L

2007-01-01

Dietary supplement use is increasingly common in the United States. Multivitamin formulations with or without minerals are typically the most common type of dietary supplement reported in surveys and studies that collect data relating to dietary supplement use. In the National Health and Nutrition Examination Survey (NHANES) 1999-2000, 52% of adults reported taking a dietary supplement in the past month, and 35% reported regular use of a multivitamin-multimineral (MVMM) product. NHANES III data indicate an overall prevalence of dietary supplement usage of 40%, with prevalence rates of 35% in NHANES II and 23% in NHANES I. Women (versus men), older age groups, non-Hispanic whites (versus non-Hispanic blacks or Mexican Americans), and those with a higher education level, lower body mass index, higher physical activity level, and more frequent consumption of wine had a greater likelihood of reporting use of MVMM supplements in NHANES 1999-2000. Data from children suggest a similar prevalence rate, but lower prevalence rates of usage were reported in studies of adolescents. Individuals who use dietary supplements (including MVMM formulations) generally report higher dietary nutrient intakes and healthier diets in studies in which dietary data were also collected. Among adults with a history of breast or prostate cancer, usage rates for dietary supplements in general and MVMMs are considerably higher (eg, 56-57% for MVMMs), and these subgroups are more likely to also report use of single vitamin and mineral supplements. Thus, MVMM use contributes a considerable proportion of nutrient intakes in the United States and may contribute to risk of excessive intakes.

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to rejected dietary...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to rejected dietary...

77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

...] Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements... entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an... reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza...

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to rejected dietary...

75 FR 8252 - Laminarin; Exemption from the Requirement of a Tolerance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... dietary supplements and texturing agents; therefore, these carbohydrates are typically consumed as a... and dietary supplements. Finally, the Agency believes that it is unlikely that any exposure to the... laminarin already consumed in foods and those allowed in dietary supplements. In sum, no dietary exposure is...

Dietary supplements and medical foods for osteopenia and osteoporosis.

PubMed

Morgan, Sarah L

2013-01-01

Dietary supplements, medical foods, and pharmaceutical agents are all used in the management of metabolic bone disease. The intended populations, governing regulations, safety standards scientific requirements, physician supervision, and distribution vary markedly between supplements, medical foods, and drugs. This article will review characteristics of dietary supplements and medical foods and their use in osteoporosis care. A study that compares the pharmacokinetics of a supplement and a medical food containing similar ingredients is used to contrast the categories of dietary supplements and medical foods. Copyright © 2013 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

Predictors of Dietary Supplement Usage among Medical Interns of Tehran University of Medical Sciences

PubMed Central

Kabiri, Sanaz; Yeganeh, Haleh Sadrzadeh; Koohdani, Fariba; Khajehnasiri, Farahnaz; Khosravi, Shahla

2015-01-01

ABSTRACT This study aimed to determine the prevalence of dietary supplement-use and its relationship with demographics and lifestyle of medical interns. The study sample comprised 356 interns aged 23 to 25 years. Participants completed a questionnaire on dietary supplement-use during the month preceding the study, information on demographic characteristics and lifestyle was also obtained. Univariable and multivariable logistic regression were employed to assess the correlates of dietary supplement-use. The prevalence of dietary supplement-use was about 33% (males 20.4% and females 43.2%, p<0.001). The most commonly-used dietary supplement was multivitamin/multivitamin-mineral (90.6% in males and 52.3% in females). Approximately 30% of supplements were used regularly (≥5 days/week) by all subjects. The most-frequently reported reasons for supplement-use in males were: enhancing daily energy/stamina (51.1%), poor food intake (13.3%) and, in females, were: improving health and nutritional status (39.3%) and reducing hair loss (23.4%). The decision to use dietary supplement was mostly driven by the interns themselves (56% in males, 61% in females). In the univariable analysis, men who exercised once or twice a week were less likely to use supplements compared to those who reported doing exercise more than twice weekly (OR=0.35, 95% CI 0.12-0.98). Females who reported their health status to be ‘excellent’ were more likely to use supplements compared to those who described their health status as ‘moderate/poor/very poor’ (OR=2.53, 95% CI 1.15-5.56) as were women who mentioned their breakfast consumption status as ‘always’ (OR=2.69, 95% CI 1.47-4.92). In the multivariable analysis, only breakfast consumption was significantly related with dietary supplement-use in females (OR=2.20, 95% CI 1.11-4.38). In conclusion, dietary supplement-use among medical interns, especially among females, was relatively very common. Dietary supplement-use was related to a healthier lifestyle. PMID:25995723

Dietary supplement use and nutrient intake in HIV-infected persons.

PubMed

Hendricks, Kristy M; Sansavero, Mara; Houser, Robert F; Tang, Alice M; Wanke, Christine A

2007-04-01

Dietary supplement use was assessed in 368 HIV-infected patients enrolled in the Nutrition for Healthy Living cohort. The objective was to describe the dietary, demographic, and health characteristics of the HIV-infected persons who use different types of dietary supplements. Each patient was categorized in 1 of 4 dietary supplement groups. Extremes in intake of micronutrients were common. Men and women who consumed no supplements reported inadequate intakes of a number of micronutrients. Men using nonvitamin/nonmineral (NVNM) supplements had diets higher in fiber, protein, and 13 of 14 vitamins and minerals. Almost 90% of male NVNM supplement users ingested 1 or more vitamins or minerals in amounts above the tolerable upper limit. Male NVNM supplement users were more likely to be white, well educated, and receiving highly active antiretroviral therapy and more likely to have higher annual incomes, higher CD4 counts, and lower HIV RNA levels. HIV-infected women who were using NVNM supplements exhibited similar trends. Micronutrient inadequacy and excess are relatively common in persons living with HIV infection. Practitioners need to judiciously address optimal nutrient intake from both diet and dietary supplements in this population.

Are dietary supplements necessary for a healthy person?

PubMed

Schwab, Ursula; Pihlajamäki, Jussi

A dietary supplement differs from conventional foods in its appearance or way of using. The formulation of a dietary supplement often resembles that of medicines. Research evidence of the benefits of dietary supplements for healthy people is insufficient. A balanced, health-promoting diet will secure adequate intake of nutrients and, based on studies, is beneficial for the prevention of numerous diseases. The use of dietary supplements is justified, if giving variety to a diet that is inadequate in its nutritive content is not possible or successful. The use should be based on careful examination of the diet as well as on reliable biochemical assays.

Utilization and Safety of Common Over-the-Counter Dietary/Nutritional Supplements, Herbal Agents, and Homeopathic Compounds for Disease Prevention.

PubMed

Trivedi, Ruchir; Salvo, Marissa C

2016-09-01

Dietary supplements are commonly used by patients as part of their medical care plan. Often clinicians may not be aware of their use, because patients do not always consider these to be medications. All clinicians need to continually ask patients about their use of dietary supplements when collecting a medication history. Dietary supplements and prescription medications often share similar enzymatic pathways for their metabolism. These interactions may lead to severe adverse reactions. This article reviews available evidence for a variety of dietary supplements in select disease categories. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of congruence among dietary supplement use and motivation for supplementation in young, Canadian athletes.

PubMed

Parnell, Jill A; Wiens, Kristin; Erdman, Kelly Anne

2015-01-01

Dietary supplement use is endemic in young athletes; however, it is unclear if their choices are congruent with their motivation for supplementation and the established benefits of the dietary supplements. The aim of this study was to evaluate the relationships between dietary supplement use and self-reported rationale in young athletes. Canadian athletes (n = 567; 11-25 years; 76% club or provincial level, 24% national or higher) completed a questionnaire designed to assess supplementation patterns and motivation for supplementation. Chi square tests examined associations between dietary supplements and self-reported rationale for use. Vitamin and mineral supplements, including vitamin-enriched water, were associated with several health- and performance- related reasons (p < 0.001). Branched chain amino acids (BCAA) and glutamine were linked to improving diet and immune function (p < 0.01), but were more strongly associated with performance reasons, as were performance foods (protein powder, sport bars, sport gels, etc.). Plant extracts and fatty acids were primarily associated with health reasons, particularly immune support (p < 0.001). Congruencies exist between performance rationales and supplementation for common ergogenic aids, however, less so for vitamin and mineral supplements, vitamin-enriched water, and plant extracts. Incongruences were found between fatty acids, protein supplements, vitamin and mineral supplements, vitamin-enriched water, and plant extracts and health motivators for supplementation. Educational interventions are essential to ensure young athletes are using dietary supplements safely and effectively.

Beware of Products Promising Miracle Weight Loss

MedlinePlus

... a combination of healthful eating and physical activity. Dietary Supplements are not FDA-Approved Under the Federal Food, Drug and Cosmetics Act (as amended by the Dietary Supplement Health and Education Act of 1994), dietary supplement ...

Ironic effects of dietary supplementation: illusory invulnerability created by taking dietary supplements licenses health-risk behaviors.

PubMed

Chiou, Wen-Bin; Yang, Chao-Chin; Wan, Chin-Sheng

2011-08-01

The use of dietary supplements and the health status of individuals have an asymmetrical relationship: the growing market for dietary supplements appears not to be associated with an improvement in public health. Building on the notion of licensing, or the tendency for positive choices to license subsequent self-indulgent choices, we argue that because dietary supplements are perceived as conferring health advantages, use of such supplements may create an illusory sense of invulnerability that disinhibits unhealthy behaviors. In two experiments, participants who took placebo pills that they believed were dietary supplements exhibited the licensing effect across multiple forms of health-related behavior: They expressed less desire to engage in exercise and more desire to engage in hedonic activities (Experiment 1), expressed greater preference for a buffet over an organic meal (Experiment 1), and walked less to benefit their health (Experiment 2) compared with participants who were told the pills were a placebo. A mediational analysis indicated that perceived invulnerability was an underlying mechanism for these effects. Thus, a license associated with the use of dietary supplements may operate within cycles of behaviors that alternately protect and endanger health.

Dietary supplements used in the treatment of depression, anxiety, and sleep disorders.

PubMed

Cauffield, J S; Forbes, H J

1999-01-01

Dietary supplement use has increased during the past decade. Epidemiologic studies suggest that patients turn to dietary supplements because of a reluctance to take prescription medications or a lack of satisfaction with the results. They often perceive dietary supplements to be a safer or more natural alternative. Patients with mental health conditions, including depression, anxiety, and sleep disorders, are among those who use dietary supplements. St. John's Wort is used to treat depression. Clinical studies comparing dietary supplements with low-dose antidepressants (maprotiline, amitriptyline, or imipramine at 75 mg/day) or high-dose antidepressants (imipramine at 150 mg/day) find no significant difference between treatments. Kava kava is used to treat anxiety. Clinical trials demonstrate it to be superior to placebo, and roughly equivalent to oxazepam 15 mg/day or bromazepam 9 mg/day. Agents discussed for use in sleep disorders include melatonin, valerian, 5-hydroxytryptamine, catnip, chamomile, gotu kola, hops, L-tryptophan, lavender, passionflower, skullcap, and valerian. Familiarity with the evidence for use and the possible resulting risks can help health professionals to guide patient decisions regarding use of dietary supplements.

Comparison of standardised dietary folate intake across ten countries participating in the European Prospective Investigation into Cancer and Nutrition.

PubMed

Park, Jin Young; Nicolas, Genevieve; Freisling, Heinz; Biessy, Carine; Scalbert, Augustin; Romieu, Isabelle; Chajès, Véronique; Chuang, Shu-Chun; Ericson, Ulrika; Wallström, Peter; Ros, Martine M; Peeters, Petra H M; Mattiello, Amalia; Palli, Domenico; María Huerta, José; Amiano, Pilar; Halkjær, Jytte; Dahm, Christina C; Trichopoulou, Antonia; Orfanos, Philippos; Teucher, Birgit; Feller, Silke; Skeie, Guri; Engeset, Dagrun; Boutron-Ruault, Marie-Christine; Clavel-Chapelon, Françoise; Crowe, Francesca; Khaw, Kay-Tee; Vineis, Paolo; Slimani, Nadia

2012-08-01

Folate plays an important role in the synthesis and methylation of DNA as a cofactor in one-carbon metabolism. Inadequate folate intake has been linked to adverse health events. However, comparable information on dietary folate intake across European countries has never been reported. The objective of the present study was to describe the dietary folate intake and its food sources in ten countries in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. A cross-sectional analysis was conducted in 36 034 participants (aged 35-74 years) who completed a single 24 h dietary recall using a computerised interview software program, EPIC-Soft® (International Agency for Research on Cancer, Lyon). Dietary folate intake was estimated using the standardised EPIC Nutrient DataBase, adjusted for age, energy intake, weight and height and weighted by season and day of recall. Adjusted mean dietary folate intake in most centres ranged from 250 to 350 μg/d in men and 200 to 300 μg/d in women. Folate intake tended to be lower among current smokers and heavier alcohol drinkers and to increase with educational level, especially in women. Supplement users (any types) were likely to report higher dietary folate intake in most centres. Vegetables, cereals and fruits, nuts and seeds were the main contributors to folate intake. Nonetheless, the type and pattern of consumption of these main food items varied across the centres. These first comparisons of standardised dietary folate intakes across different European populations show moderate regional differences (except the UK health conscious group), and variation by sex, educational level, smoking and alcohol-drinking status, and supplement use.

Dietary interventions, lifestyle changes, and dietary supplements in preventing gestational diabetes mellitus: a literature review.

PubMed

Facchinetti, Fabio; Dante, Giulia; Petrella, Elisabetta; Neri, Isabella

2014-11-01

Gestational diabetes mellitus (GDM) is associated with increased rates of fetal morbidity and mortality, both during the pregnancy and in the postnatal life. Current treatment of GDM includes diet with or without medications, but this management is expensive and poorly cost-effective for the health care systems. Strategies to prevent such condition would be preferable with respect to its treatment. The aim of this literature review was to evaluate studies reporting the efficacy of the most used approaches to prevent GDM as well as evidences of efficacy and safety of dietary supplementations. Systematic literature searches were performed in electronic databases, covering the period January 1983 to April 2014. Randomized controlled clinical trials were included. Quality of the articles was evaluated with the Jadad scale. We did not evaluate those articles that were already entered in the most recent systematic reviews, and we completed the research with the trials published thereafter. Of 55 articles identified, 15 randomized controlled trials were eligible. Quality and heterogeneity of the studies cannot allow firm conclusions. Anyway, trials in which only intake or expenditure has been targeted mostly reported negative results. On the contrary, combined lifestyle programs including diet control (orienting food intake, restricting energy intake) associated with moderate but continuous physical activity exhibit better efficacy in reducing GDM prevalence. The results from dietary supplements with myoinositol or probiotics are promising. The actual evidences provide enough arguments for implementing large-scale, high-quality randomized controlled trials looking at the possible benefits of these new approaches for preventing GDM.

Perceived efficacy, indications, and information sources for medically indigent patients and their healthcare providers regarding dietary supplements.

PubMed

Clay, Patrick G; Glaros, Alan G; Clauson, Kevin A

2006-03-01

Evidence exists that medically indigent and minority patients use dietary supplements at rates as high or higher than that of the general population. Safety concerns regarding the use of dietary supplements are further exacerbated by a suboptimal level of patient disclosure and provider inquiry. To determine dietary supplement use, indications, perceived efficacy, and information sources of patients and providers using a pilot study in a clinic for the medically indigent. Five hundred self-administered patient surveys and 50 healthcare provider surveys were made available to any patient at a free health clinic in Kansas City, MO. Surveys were collected and descriptive analyses were performed. Three hundred eleven patient surveys were returned. Of the 37.3% (116/311) of respondents who had used dietary supplements, 13.8% (n = 16) had 10 comorbid conditions. Ninety-six dietary supplements were used for 8 medical condition categories. The 9 agents most frequently reported used were garlic (n = 32), aloe/green tea (n = 27 each), chamomile/echinacea (n = 24 each), St. John's wort (n = 22), ginseng (n = 18), and cranberry/Ginkgo biloba (n = 17 each). Patients reported a broad range of indications for taking dietary supplements. Patients reported (mean +/- SD) 2.37 +/- 4.23 agents as effective and 0.78 +/- 1.73 as ineffective or harmful. Provider surveys revealed that 60% (21/35) and 74% (26/35) were currently or had ever used dietary supplements, respectively. Fifty-seven percent (20/35) of providers reported attending educational programs on dietary supplements, and providers perceived patient supplement use to be most influenced by advertisements (40%) and friends (40%). The medically indigent population uses a wide variety of dietary supplements. There is little consistency in perceived indications, which may prevent clinicians from accurately predicting specific herbal use rationale given any individual's or population's set of comorbid conditions. Clinicians are encouraged to accurately determine their individual practice setting's use pattern.

DSHEA's third-party literature exemption; mail order sales, direct marketing, and Internet use.

PubMed

Raubicheck, C J

1999-01-01

This article examines ways in which marketers of dietary supplements can make use of the "third-party literature" section of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This provision permits persons or entities, other than manufacturers or distributors, to distribute to consumers certain publications in connection with the sale of particular supplements. These publications may include statements about the therapeutic benefits of such products without subjecting the products to regulation by the Food and Drug Administration (FDA) as unapproved new drugs. Specifically, this article addresses the following: Can a dietary supplement manufacturer or distributor send third-party literature about a dietary supplement to a customer in a mail order sales transaction? Can third-party literature be disseminated by mail with dietary supplement catalogues only? Can third-party literature be disseminated by sales representatives engaged in direct marketing of dietary supplements? Can third-party literature appear on the Internet? The answer appears to be affirmative in each of these situations.

Mixing Medications and Dietary Supplements Can Endanger Your Health

MedlinePlus

... Home For Consumers Consumer Updates Mixing Medications and Dietary Supplements Can Endanger Your Health Share Tweet Linkedin Pin ... you take also a vitamin, mineral, or other dietary supplements? Have you considered whether there is any danger ...

Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

PubMed

Wallace, Taylor C

2015-08-01

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. © 2015 American Society for Nutrition.

UHPLC/HRMS Analysis of African Mango (Irvingia gabonensis) Seeds, Extract and Related Dietary Supplements

PubMed Central

Sun, Jianghao; Chen, Pei

2012-01-01

Dietary Supplements based on an extract from Irvingia gabonensis (African Mango, AM for abbreviation) seeds are one of the popular herbal weight loss dietary supplements in the US market. The extract is believed to be a natural and healthy way to lose weight and improve overall health. However, the chemical composition of African mango based-dietary supplements (AMDS) has never been reported. In this study, the chemical constituents of African mango seeds, African mango seeds extract (AMSE), and different kinds of commercially available African mango based dietary supplements (AMDS) have been investigated using an ultra high-performance liquid chromatography with high resolution mass spectrometry (UHPLC-HRMS) method. Ellagic acid, mono, di, tri-O methyl-ellagic acids and their glycosides were found as major components in African Mango seeds. These compounds may be used for quality control of African Mango extract and related dietary supplements. PMID:22880691

Analysis of the accuracy and readability of herbal supplement information on Wikipedia.

PubMed

Phillips, Jennifer; Lam, Connie; Palmisano, Lisa

2014-01-01

To determine the completeness and readability of information found in Wikipedia for leading dietary supplements and assess the accuracy of this information with regard to safety (including use during pregnancy/lactation), contraindications, drug interactions, therapeutic uses, and dosing. Cross-sectional analysis of Wikipedia articles. The contents of Wikipedia articles for the 19 top-selling herbal supplements were retrieved on July 24, 2012, and evaluated for organization, content, accuracy (as compared with information in two leading dietary supplement references) and readability. Accuracy of Wikipedia articles. No consistency was noted in how much information was included in each Wikipedia article, how the information was organized, what major categories were used, and where safety and therapeutic information was located in the article. All articles in Wikipedia contained information on therapeutic uses and adverse effects but several lacked information on drug interactions, pregnancy, and contraindications. Wikipedia articles had 26%-75% of therapeutic uses and 76%-100% of adverse effects listed in the Natural Medicines Comprehensive Database and/or Natural Standard. Overall, articles were written at a 13.5-grade level, and all were at a ninth-grade level or above. Articles in Wikipedia in mid-2012 for the 19 top-selling herbal supplements were frequently incomplete, of variable quality, and sometimes inconsistent with reputable sources of information on these products. Safety information was particularly inconsistent among the articles. Patients and health professionals should not rely solely on Wikipedia for information on these herbal supplements when treatment decisions are being made.

Overview of regulation of dietary supplements in the USA and issues of adulteration with phenethylamines (PEAs).

PubMed

Pawar, Rahul S; Grundel, Erich

2017-03-01

The multi-billion dollar dietary supplement industry is global in reach. The industry has been criticized for problems related to poor quality control, safety, misbranding, and adulteration. In this review, we describe how the US Food and Drug Administration (FDA) regulates dietary supplements within the framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the FD&C Act, gave the FDA the authority to promulgate Good Manufacturing Practices for dietary supplements and required that manufacturers provide the FDA information supporting a conclusion that the ingredients are reasonably expected to be safe if the dietary ingredients were not marketed in the USA before 15 October 1994. Recent amendments to the FD&C Act require that serious dietary-supplement-related adverse events be reported to the FDA and provide the agency with mandatory recall authority. We discuss the presence of naturally occurring (e.g. Ephedra, Citrus aurantium, Acacia) and synthetic (e.g. β-methylphenethylamines, methylsynephrine, α-ethyl-phenethylamine) biologically active phenethylamines (PEAs) in dietary supplements and of PEA drugs (e.g. clenbuterol, fenfluramine, sibutramine, lorcaserin) in weight-loss products. Regulatory actions against manufacturers of products labelled as dietary supplements that contain the aliphatic amines 1,3-dimethylamine and 1,3-dimethylbutylamine, and PEAs such as β-methylphenethylamine, aegeline, and Dendrobium illustrate the FDA's use of its authority under the FD&C Act to promote dietary supplement safety. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Physician-patient communication about dietary supplements.

PubMed

Tarn, Derjung M; Paterniti, Debora A; Good, Jeffrey S; Coulter, Ian D; Galliher, James M; Kravitz, Richard L; Karlamangla, Arun S; Wenger, Neil S

2013-06-01

Describe the content and frequency of provider-patient dietary supplement discussions during primary care office visits. Inductive content analysis of 1477 transcribed audio-recorded office visits to 102 primary care providers was combined with patient and provider surveys. Encounters were collected in Los Angeles, CA (2009-2010), geographically diverse practice settings across the United States (2004-2005), and Sacramento, CA (1998-1999). Providers discussed 738 dietary supplements during encounters with 357 patients (24.2% of all encounters in the data). They mentioned: (1) reason for taking the supplement for 46.5% of dietary supplements; (2) how to take the supplement for 28.2%; (3) potential risks for 17.3%; (4) supplement effectiveness for 16.7%; and (5) supplement cost or affordability for 4.2%. Of these five topics, a mean of 1.13 (SD=1.2) topics were discussed for each supplement. More topics were reviewed for non-vitamin non-mineral supplements (mean 1.47 (SD=1.2)) than for vitamin/mineral supplements (mean 0.99 (SD=1.1); p<0.001). While discussions about supplements are occurring, it is clear that more discussion might be needed to inform patient decisions about supplement use. Physicians could more frequently address topics that may influence patient dietary supplement use, such as the risks, effectiveness, and costs of supplements. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

6 Things to Know about Type 2 Diabetes and Dietary Supplements

MedlinePlus

... Things To Know About Type 2 Diabetes and Dietary Supplements Share: Diabetes is a group of chronic diseases ... Researchers are studying several complementary health approaches, including dietary supplements, to see if they can help people manage ...

Prostate Cancer, Nutrition, and Dietary Supplements (PDQ®)—Patient Version

Cancer.gov

Prostate Cancer, Nutrition, and Dietary Supplements summary discusses the use of nutrition and dietary supplements for preventing or treating prostate cancer. Learn more about the use of complementary therapies for prostate cancer in this expert-reviewed summary.

An evidence-based elective on dietary supplements.

PubMed

Bonafede, Machaon; Caron, Whitney; Zeolla, Mario

2009-08-28

To implement and evaluate the effectiveness of a pharmacy elective on dietary supplements that emphasized evidence-based care. A 3-credit elective that employed both traditional lectures and a variety of active-learning exercises was implemented. The course introduction provided a background in dietary supplement use and evidence-based medicine principles before addressing dietary supplements by primary indication. Student learning was assessed through quizzes, case assignments, discussion board participation, and completion of a longitudinal group project. Precourse and postcourse surveys were conducted to assess students' opinions, knowledge, and skills related to course objectives. The course was an effective way to increase students' knowledge of dietary supplements and skills and confidence in providing patient care in this area.

Dietary Recommendations for Adults With Psoriasis or Psoriatic Arthritis From the Medical Board of the National Psoriasis Foundation: A Systematic Review.

PubMed

Ford, Adam R; Siegel, Michael; Bagel, Jerry; Cordoro, Kelly M; Garg, Amit; Gottlieb, Alice; Green, Lawrence J; Gudjonsson, Johann E; Koo, John; Lebwohl, Mark; Liao, Wilson; Mandelin, Arthur M; Markenson, Joseph A; Mehta, Nehal; Merola, Joseph F; Prussick, Ronald; Ryan, Caitriona; Schwartzman, Sergio; Siegel, Evan L; Van Voorhees, Abby S; Wu, Jashin J; Armstrong, April W

2018-06-20

Psoriasis is a chronic, inflammatory skin disease and has significant associated morbidity and effect on quality of life. It is important to determine whether dietary interventions help reduce disease severity in patients with psoriatic diseases. To make evidence-based dietary recommendations for adults with psoriasis and/or psoriatic arthritis from the Medical Board of the National Psoriasis Foundation. We used literature from prior systematic reviews as well as additional primary literature from the MEDLINE database from January 1, 2014, to August 31, 2017, that evaluated the impact of diet on psoriasis. We included observational and interventional studies of patients with psoriasis or psoriatic arthritis. The quality of included studies was assessed using the Newcastle-Ottawa scale for observational studies and the Cochrane Risk of Bias Tool for interventional studies. We made evidence-based dietary recommendations, which were voted on by the National Psoriasis Foundation Medical Board. We identified 55 studies meeting the inclusion criteria for this review. These studies represent 77 557 unique participants of which 4534 have psoriasis. Based on the literature, we strongly recommend dietary weight reduction with a hypocaloric diet in overweight and obese patients with psoriasis. We weakly recommend a gluten-free diet only in patients who test positive for serologic markers of gluten sensitivity. Based on low-quality data, select foods, nutrients, and dietary patterns may affect psoriasis. For patients with psoriatic arthritis, we weakly recommend vitamin D supplementation and dietary weight reduction with a hypocaloric diet in overweight and obese patients. Dietary interventions should always be used in conjunction with standard medical therapies for psoriasis and psoriatic arthritis. Adults with psoriasis and/or psoriatic arthritis can supplement their standard medical therapies with dietary interventions to reduce disease severity. These dietary recommendations from the National Psoriasis Foundation Medical Board will help guide clinicians regarding the utility of dietary interventions in adults with psoriatic diseases.

Why US children use dietary supplements.

PubMed

Bailey, Regan L; Gahche, Jaime J; Thomas, Paul R; Dwyer, Johanna T

2013-12-01

Dietary supplements are used by one-third of children. We examined motivations for supplement use in children, the types of products used by motivations, and the role of physicians and health care practitioners in guiding choices about supplements. We examined motivations for dietary supplement use reported for children (from birth to 19 y of age; n = 8,245) using the National Health and Nutrition Examination Survey 2007-2010. Dietary supplements were used by 31% of children; many different reasons were given as follows: to "improve overall health" (41%), to "maintain health" (37%), for "supplementing the diet" (23%), to "prevent health problems" (20%), and to "boost immunity" (14%). Most children (~90%) who use dietary supplements use a multivitamin-mineral or multivitamin product. Supplement users tend to be non-Hispanic white, have higher family incomes, report more physical activity, and have health insurance. Only a small group of supplements used by children (15%) were based on the recommendation of a physician or other health care provider. Most supplements used by children are not under the recommendation of a health care provider. The most common reasons for use of supplements in children are for health promotion, yet little scientific data support this notion in nutrient-replete children.

The association between postdiagnosis dietary supplement use and total mortality differs by diet quality among older female cancer survivors.

PubMed

Inoue-Choi, Maki; Greenlee, Heather; Oppeneer, Sarah J; Robien, Kim

2014-05-01

Dietary supplements are widely used by cancer survivors. However, health effects among older cancer survivors are unclear. We used the Iowa Women's Health Study, a prospective cohort study with 2,118 postmenopausal women with a confirmed cancer diagnosis (1986-2002), to evaluate the association between postdiagnosis dietary supplement use assessed in 2004 and subsequent all-cause mortality. Risk of death was evaluated using multivariable-adjusted Cox proportional hazards regression. We performed stratified analyses by diet quality score, dietary micronutrient intake, and perceived general health. Through 2010, 608 deaths were identified. Approximately 85% of the cancer survivors used dietary supplements. Overall supplement use and multivitamin use were not associated with mortality. Iron supplement use was associated with 39% higher risk of death [95% confidence interval (CI), 1.09-1.77]. This association was stronger among survivors with deteriorating general health. Folic acid supplement use was associated with higher risk of death, only among survivors reporting low-quality diets (HR, 2.33; 95% CI, 1.33-4.08; P interaction = 0.006). Multivitamin use and using a greater number of supplements was associated with a trend towards higher mortality only among those with poor diet quality. Using vitamin E supplements in combination with multivitamin was associated with lower risk of death only among survivors with higher dietary vitamin E intake (HR, 0.61; 95% CI, 0.39-0.94; P interaction = 0.02). Postdiagnosis supplement use was associated with higher mortality among older female cancer survivors with poor general health and/or poor dietary intake. The association between postdiagnosis dietary supplement use and mortality may differ by diet quality and health status among older female cancer survivors. ©2014 AACR.

The association between postdiagnosis dietary supplement use and total mortality differs by diet quality among older female cancer survivors

PubMed Central

Inoue-Choi, Maki; Greenlee, Heather; Oppeneer, Sarah J.; Robien, Kim

2014-01-01

Background Dietary supplements are widely used by cancer survivors. However, health effects among older cancer survivors are unclear. Methods We used the Iowa Women’s Health Study, a prospective cohort study with 2,118 postmenopausal women with a confirmed cancer diagnosis (1986–2002), to evaluate the association between postdiagnosis dietary supplement use assessed in 2004 and subsequent all-cause mortality. Risk of death was evaluated using multivariable-adjusted Cox proportional hazards regression. We performed stratified analyses by diet quality score, dietary micronutrient intake, and perceived general health. Results Through 2010, 608 deaths were identified. Approximately 85% of the cancer survivors used dietary supplements. Overall supplement use and multivitamin (MV) use were not associated with mortality. Iron supplement use was associated with 39% higher risk of death (95%CI=1.09–1.77). This association was stronger among survivors with deteriorating general health. Folic acid supplement use was associated with higher risk of death, only among survivors reporting low quality diets (HR=2.33, 95%CI=1.33–4.08, pinteraction=0.006). MV use and using a greater number of supplements was associated with a trend towards higher mortality only among those with poor diet quality. Using vitamin E supplements in combination with MV was associated with lower risk of death only among survivors with higher dietary vitamin E intake (HR=0.61, 95%CI=0.39–0.94, pinteraction=0.02). Conclusions Postdiagnosis supplement use was associated with higher mortality among older female cancer survivors with poor general health and/or poor dietary intake. Impact The association between postdiagnosis dietary supplement use and mortality may differ by diet quality and health status among older female cancer survivors. PMID:24621441

Time to Talk: 6 Things You Should Know about Dietary Supplements for Osteoarthritis

MedlinePlus

... Y Z 6 Things You Should Know About Dietary Supplements for Osteoarthritis Share: Osteoarthritis is the most common ... hormones). Many people with OA report trying various dietary supplements, including glucosamine and chondroitin, alone or in combination, ...

78 FR 18351 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a... manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is...

Estimation of total usual calcium and vitamin D intakes in the United States.

PubMed

Bailey, Regan L; Dodd, Kevin W; Goldman, Joseph A; Gahche, Jaime J; Dwyer, Johanna T; Moshfegh, Alanna J; Sempos, Christopher T; Picciano, Mary Frances

2010-04-01

Our objective in this study was to estimate calcium intakes from food, water, dietary supplements, and antacids for U.S. citizens aged >or=1 y using NHANES 2003-2006 data and the Dietary Reference Intake panel age groupings. Similar estimates were calculated for vitamin D intake from food and dietary supplements using NHANES 2005-2006. Diet was assessed with 2 24-h recalls; dietary supplement and antacid use were determined by questionnaire. The National Cancer Institute method was used to estimate usual nutrient intake from dietary sources. The mean daily nutrient intake from supplemental sources was added to the adjusted dietary intake estimates to produce total usual nutrient intakes for calcium and vitamin D. A total of 53% of the U.S. population reported using any dietary supplement (2003-2006), 43% used calcium (2003-2006), and 37% used vitamin D (2005-2006). For users, dietary supplements provided the adequate intake (AI) recommendation for calcium intake for approximately 12% of those >or=71 y. Males and females aged 1-3 y had the highest prevalence of meeting the AI from dietary and total calcium intakes. For total vitamin D intake, males and females >or=71, and females 14-18 y had the lowest prevalence of meeting the AI. Dietary supplement use is associated with higher prevalence of groups meeting the AI for calcium and vitamin D. Monitoring usual total nutrient intake is necessary to adequately characterize and evaluate the population's nutritional status and adherence to recommendations for nutrient intake.

Volumetric Titrations Using Electrolytically Generated Reagents for the Determination of Ascorbic Acid and Iron in Dietary Supplement Tablets: An Undergraduate Laboratory Experiment

ERIC Educational Resources Information Center

Scanlon, Christopher; Gebeyehu, Zewdu; Griffin, Kameron; Dabke, Rajeev B.

2014-01-01

An undergraduate laboratory experiment for the volumetric quantitative analysis of ascorbic acid and iron in dietary supplement tablets is presented. Powdered samples of the dietary supplement tablets were volumetrically titrated against electrolytically generated reagents, and the mass of dietary reagent in the tablet was determined from the…

Total folate and folic acid intakes from foods and dietary supplements of US children aged 1–13 y1234

PubMed Central

Bailey, Regan L; McDowell, Margaret A; Dodd, Kevin W; Gahche, Jaime J; Dwyer, Johanna T; Picciano, Mary Frances

2010-01-01

Background: Total folate intake includes naturally occurring food folate and folic acid from fortified foods and dietary supplements. Recent reports have focused on total folate intakes of persons aged ≥14 y. Information on total folate intakes of young children, however, is limited. Objective: The objective was to compute total folate and total folic acid intakes of US children aged 1–13 y by using a statistical method that adjusts for within-person variability and to compare these intakes with the Dietary Reference Intake guidelines for adequacy and excess. Design: Data from the 2003–2006 National Health and Nutrition Examination Survey, a nationally representative cross-sectional survey, were analyzed. Total folate intakes were derived by combining intakes of food folate (naturally occurring and folic acid from fortified foods) on the basis of 24-h dietary recall results and folic acid intakes from dietary supplements on the basis of a 30-d questionnaire. Results: More than 95% of US children consumed at least the Estimated Average Requirement (EAR) for folate from foods alone. More than one-third (35%) of US children aged 1–13 y used dietary supplements, and 28% used dietary supplements containing folic acid. Supplement users had significantly higher total folate and folic acid intakes than did nonusers. More than half (53%) of dietary supplement users exceeded the Tolerable Upper Intake Level (UL) for total folic acid (fortified food + supplements) as compared with 5% of nonusers. Conclusions: Total folate intakes of most US children aged 1–13 y meet the EAR. Children who used dietary supplements had significantly higher total folate intakes and exceeded the UL by >50%. PMID:20534747

Gene expression profiling as an initial approach for mechanistic studies of toxicity and tumorigenicity of herbal plants and herbal dietary supplements.

PubMed

Guo, Lei; Mei, Nan; Xia, Qingsu; Chen, Tao; Chan, Po-Chuen; Fu, Peter P

2010-01-01

Dietary supplements are consumed by more than 300 million people worldwide, and herbal dietary supplements represent the most rapidly growing portion of this industry. Even though adverse health effects of many herbal dietary supplements have been reported, safety assurances are not being addressed adequately. Toxicological data on the identification of genotoxic and tumorigenic ingredients in many raw herbs are also lacking. Currently, more than 30 herbal dietary supplements and active ingredients have been selected by the National Toxicology Program (NTP) for toxicity and tumorigenicity studies. Due to the complexity of the chemical components present in plant extracts, there are no established methodologies for determining the mechanisms of toxicity (particularly tumorigenicity) induced by herbs, such as Gingko biloba leaf extract (GBE) and other herbal plant extracts. Consequently, the understanding of toxicity of herbal dietary supplements remains limited. We have proposed that application of DNA microarrays could be a highly practical initial approach for revealing biological pathways and networks associated with toxicity induced by herbal dietary supplements and the generation of hypotheses to address likely mechanisms. The changes in expression of subsets of genes of interest, such as the modulation of drug metabolizing genes, can be analyzed after treatment with an herbal dietary supplement. Although levels of gene expression do not represent fully the levels of protein activities, we propose that subsequent biochemical and genomic experiments based on these initial observations will enable elucidation of the mechanisms leading to toxicity, including tumorigenicity. This review summarizes the current practices of microarray analysis of gene expressions in animals treated with herbal dietary supplements and discusses perspectives for the proposed strategy.

Evaluation of Injuries among Command and General Staff College Students, Ft. Leavenworth, Kansas

DTIC Science & Technology

2015-11-30

ounces or 2 bottles 7 (4%) 60 ounces or 3 bottles 1 (1%) Table F-3. Dietary Supplement Use, CGSC Initial Survey Respondents (n=185) Question... Supplement /Reason N (%) Dietary Supplements Do not take 133 (58%) Vitamins/ Multivitamins 44 (19%) Performance/muscle enhancement 19 (8%) Healthy joint...15 (7%) Nutrition enhancement 9 (4%) Weight loss 9 (4%) Reasons for Taking Dietary Supplements (among those using supplements (n=96)) Promote

Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States

PubMed Central

2015-01-01

Millions of people in the United States consume dietary supplements hoping to maintain or improve their health; however, extensive research has failed to demonstrate the efficacy of numerous supplements in disease prevention. In addition, concerns about the safety of routine and high-dose supplementation have been raised. The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. If the composition and quality of ingredients cannot be reliably ensured, the validity of research on dietary supplements is questionable. Moreover, the health of the US public is put at risk. PMID:25602879

Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: a legislative and regulatory perspective.

PubMed

Collins, Nancy; Tighe, Ann P; Brunton, Stephen A; Kris-Etherton, Penny M

2008-12-01

The medical management of many diseases and conditions can include either restriction or provision of specific essential nutrients. When such nutrients are needed, there are often both prescription and nonprescription products available, as in the case of nicotinic acid or omega-3 fatty acids. Although they may seem to contain similar ingredients, there may be important differences between the prescription and dietary-supplement preparations. The manufacturing of prescription pharmaceutical products is regulated by the US Food and Drug Administration (FDA), which mandates standards for consistency and quality assurance. Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act of 1994, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturer prove that the supplement is safe. Consumers and medical professionals should be aware of the important qualitative and quantitative differences between the FDA-approved prescription formulations and dietary supplements, particularly when an essential nutrient is part of the medical management of a disease or condition.

Excessive consumption of dietary supplements among professionals working in gyms in Pelotas, Rio Grande do Sul State, Brazil, 2012.

PubMed

Cava, Tatiane Araujo; Madruga, Samanta Winck; Teixeira, Gesiane Dias Trindade; Reichert, Felipe Fossati; Silva, Marcelo Cozzensa da; Rombaldi, Airton José

2017-01-01

to investigate the prevalence and factors associated with excessive consumption of dietary supplements among professionals working at gyms in Pelotas, Rio Grande do Sul State, Brazil. this is a cross-sectional study with all local fitness professionals identified in 2012; excessive consumption of dietary supplements was defined as the use of three or more types of supplements simultaneously; multivariate analysis was carried out using Poisson regression with robust variance. 497 professionals were interviewed; the prevalence of excessive consumption of dietary supplements was 10.5% (95%CI 7.9;13.5); there was association with the male sex (PR=3.2; 95%CI 1.6;6.7) and with length of time of dietary supplement consumption ≥4 years when compared to <1 year (PR=2.8; 95%CI 1.7;4.7); lower consumption was found among professionals with higher levels of education, regardless of whether they had a degree in physical education or not (p=0,007). prevalence of excessive consumption of dietary supplements can be considered high and was associated with sociodemographic variables.

Dietary supplementation during diabetes therapy and the potential risk of interactions.

PubMed

Zabłocka-Słowińska, Katarzyna; Dzielska, Ewelina; Gryszkin, Iwona; Grajeta, Halina

2014-01-01

The classification of dietary supplements as foodstuffs promotes widespread access to them and increases the possibility of patients using them without being monitored. Unreasonable or excessive consumption of these preparations poses risks to type-2 diabetes mellitus (T2DM) patients (among others) because it may induce disturbances in glycemic control. The aim of this study was to assess the frequency of dietary supplementation among patients using anti-diabetic drugs and such patients' nutrient intake in order to evaluate the potential risk of interactions. The study participants were 150 diabetic patients who were asked about the type of pharmacotherapy and dietary supplementation they used. The intake of minerals, vitamins, dietary fiber and long-chain polyunsaturated fatty acids (LC-PUFAs) from the patients' diets were also assessed, using the 24-h dietary recall method. The highest percentage of patients taking individual anti-diabetic drugs used supplements containing magnesium and herbs. They also often took antioxidant vitamins, B-group vitamins and omega-3 fatty acids. In the majority of patients (both those using supplements and those not), the dietary recall showed insufficient intake of potassium, calcium and magnesium, as well as of vitamin E, folic acid, vitamin D and LC-PUFAs. In addition, their diets provided high median amounts of iron, copper, vitamin A and β-carotene. The level of dietary supplementation and the ill-balanced diets reported by the majority of the recruited T2DM patients indicate a high possible risk of interactions with the anti-diabetic drugs. Therefore, patients should always consult their physicians regarding dietary supplementation, and medically trained staff should routinely assess dietary intake to avoid hazardous changes in the activity of drugs.

76 FR 76417 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-07

...); biologics; medical devices; dietary supplements and other special nutritional products (e.g., infant formula... supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary supplements do not require premarket approval by FDA and the Agency bears the burden to gather and review evidence that a dietary supplement may...

Physician-Patient Communication about Dietary Supplements

PubMed Central

Tarn, Derjung M.; Paterniti, Debora A.; Good, Jeffrey S.; Coulter, Ian D.; Galliher, James M.; Kravitz, Richard L.; Karlamangla, Arun; Wenger, Neil S.

2013-01-01

Objective Describe the content and frequency of provider-patient dietary supplement discussions during primary care office visits. Methods Inductive content analysis of 1477 transcribed audio-recorded office visits to 102 primary care providers was combined with patient and provider surveys. Encounters were collected in Los Angeles, California (2009–2010), geographically-diverse practice settings across the United States (2004–2005), and Sacramento, CA (1998–1999). Results Providers discussed 738 dietary supplements during encounters with 357 patients (24.2% of all encounters in the data). They mentioned: 1) reason for taking the supplement for 46.5% of dietary supplements; 2) how to take the supplement for 28.2%; 3) potential risks for 17.3%; 4) supplement effectiveness for 16.7%; and 5) supplement cost or affordability for 4.2%. Of these five topics, a mean of 1.13 (SD=1.2) topics were discussed for each supplement. More topics were reviewed for non-vitamin non-mineral supplements (mean 1.47 (SD=1.2)) than for vitamin/mineral supplements (mean 0.99 (SD=1.1); p<0.001). Conclusion While discussions about supplements are occurring, it is clear that more discussion might be needed to inform patient decisions about supplement use. Practice Implication Physicians could more frequently address topics that may influence patient dietary supplement use, such as the risks, effectiveness, and costs of supplements. PMID:23466249

Rosaceae products: Anthocyanin quality and comparisons between dietary supplements and foods

USDA-ARS?s Scientific Manuscript database

Rosaceae (strawberry, cherry, blackberry, red raspberry, and black raspberry) dietary supplements and food products (total n=74) were purchased and analyzed to determine their anthocyanin concentrations and profiles. Eight of the 33 dietary supplements had no detectable anthocyanins (five samples) o...

78 FR 76836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements..., or Holding Operations for Dietary Supplements--21 CFR Part 111 (OMB Control Number 0910-0606...

75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-14

... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either... in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111...

Determination of fat-soluble vitamins and carotenoids in standard reference material 3280 multivitamin/multielement tablets by liquid chromatography with absorbance detection.

PubMed

Thomas, Jeanice B; Sharpless, Katherine E; Yen, James H; Rimmer, Catherine A

2011-01-01

The concentrations of selected fat-soluble vitamins and carotenoids in Standard Reference Material (SRM) 3280 Multivitamin/Multielement Tablets have been determined by two independent LC methods, with measurements performed by the National Institute of Standards and Technology (NIST). This SRM has been prepared as part of a collaborative effort between NIST and the National Institutes of Health Office of Dietary Supplements. The SRM is also intended to support the Dietary Supplement Ingredient Database that is being established by the U.S. Department of Agriculture. The methods used at NIST to determine the concentration levels of vitamins A and E, and beta-carotene in the SRM used RPLC with absorbance detection. The relative precision of these methods ranged from 2 to 8% for the analytes measured. SRM 3280 is primarily intended for use in validating analytical methods for the determination of selected vitamins, carotenoids, and elements in multivitamin/multielement tablets and similar matrixes.

Protecting military personnel from high risk dietary supplements.

PubMed

Deuster, Patricia A; Lieberman, Harris R

2016-01-01

It is legal tomarketmost naturally occurring substances as dietary supplements in the USA without manufacturers demonstrating they are safe or effective, and an endless variety of ingredients, from esoteric botanicals to unapproved pharmaceuticals, can be found in dietary supplements. Use of certain supplements can pose a risk, but since a robust reporting systemdoes not exist in the USA it is difficult to know which are problematic and the number of adverse events (AE) resulting from their use. Certain populations, includingmilitary personnel, aremore likely to use dietary supplements than the general population. Approximately 70% of military personnel take dietary supplements while about 50% of civilians do. Service members prefer supplements purported to enhance physical performance such as supposedly natural stimulants, protein and amino acids, and combination products. Since some of thesemay be problematic, Servicemembers are probably at higher risk of injury than the general population. Ten percent of military populations appear to be taking potentially risky supplements, and the US Department of Defense (DoD) has taken variousmeasures to protect uniformed personnel including education, policy changes, and restricting sales. Actions taken include launching Operation Supplement Safety (OPSS), introducing a High Risk Supplement list, educating health care professionals on reporting AE thatmight be associated with dietary supplements, recommending policy for reporting AE, and developing an online AE reporting system. OPSS is a DoD-wide effort to educate service members, leaders, health care providers, military families, and retirees on how to safely select supplements

Identifying and assessing views among physically-active adult gym members in Israel on dietary supplements.

PubMed

Druker, Inbal; Gesser-Edelsburg, Anat

2017-01-01

Sports dietary supplements are available for sale in public places including sports clubs. Although there is uncertainty regarding their safety, many gym members who regularly work out consume them. The present study aimed to identify the approaches and perspectives of the public who work out in gyms and take dietary supplements. It examined how professionals view sports dietary supplement consumption, and how they communicate this issue to gym members. The literature discusses the prevalence of SDS use among athletes, but rarely discusses or compares between the risk perceptions of gym members, trainers, and dietitians, who represent the physically-active general public, regarding SDS. We conducted constructivist qualitative research in semi-structured one-on-one interviews ( n  = 34). We held in-depth interviews ( n  = 20) with a heterogeneous population of adult gym members who take dietary supplements, and ( n  = 14) with dietitians and fitness trainers. The main finding was a gap in risk perception of dietary supplement use between dietitians, gym members and fitness trainers. There was low risk perception among dietary supplements consumers. Trainers believed that benefits of supplement consumption exceeded risk, and therefore they did not convey a message to their clients about risk. In contrast, dietitians interviewed for this study renounced general use of sports dietary supplements and doubted whether trainers had proper nutritional knowledge to support it. Lack of awareness of risks suggests that there is a need for communication on this issue. We recommend that professionals (physicians and dietitians) be present in sports clubs that sell such products in an uncontrolled way.

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

PubMed

Abe, Andrew M; Hein, Darren J; Gregory, Philip J

2015-06-01

Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

An Increase in Dietary Supplement Exposures Reported to US Poison Control Centers.

PubMed

Rao, Nisha; Spiller, Henry A; Hodges, Nichole L; Chounthirath, Thiphalak; Casavant, Marcel J; Kamboj, Amrit K; Smith, Gary A

2017-09-01

The objective of this study was to investigate the epidemiology of dietary supplement exposures in the USA. A retrospective analysis was conducted of out-of-hospital dietary supplement exposures reported to the National Poison Data System from 2000 through 2012. There were 274,998 dietary supplement exposures from 2000 through 2012. The annual rate of dietary supplement exposures per 100,000 population increased by 46.1% during 2000-2002, decreased 8.8% during 2002-2005, and then increased again by 49.3% from 2005 to 2012. These trends were influenced by the decrease in ma huang exposures starting in 2002. Miscellaneous dietary supplements accounted for 43.9% of all exposures, followed by botanicals (31.9%), hormonal products (15.1%), and other supplements (5.1%). The majority of dietary supplement exposures (70.0%) occurred among children younger than 6 years old and were acute (94.0%) and unintentional (82.9%). Serious medical outcomes accounted for 4.5% of exposures and most (95.0%) occurred among individuals 6 years and older. Ma huang products, yohimbe, and energy products were the categories associated with the greatest toxicity. There was an overall increase in the rate of dietary supplement exposures from 2000 through 2012. Although the majority of these exposures did not require treatment at a health care facility or result in serious medical outcomes, exposures to yohimbe and energy products were associated with considerable toxicity. Our results demonstrate the success of the FDA ban on ma huang products and the need for FDA regulation of yohimbe and energy products in the USA.

Thyroxine and triiodothyronine content in commercially available thyroid health supplements.

PubMed

Kang, Grace Y; Parks, Jonathan R; Fileta, Bader; Chang, Audrey; Abdel-Rahim, Maged M; Burch, Henry B; Bernet, Victor J

2013-10-01

As defined by the Dietary Supplement Health and Education Act 1997, such substances as herbs and dietary supplements fall under general Food and Drug Administration supervision but have not been closely regulated to date. We examined the thyroid hormone content in readily available dietary health supplements marketed for "thyroid support." Ten commercially available thyroid dietary supplements were purchased. Thyroid supplements were dissolved in 10 mL of acetonitrile and water with 0.1% trifloroacetic acid and analyzed using high-performance liquid chromatography for the presence of both thyroxine (T4) and triiodothyronine (T3) using levothyroxine and liothyronine as a positive controls and standards. The amount of T4 and T3 was measured separately for each supplement sample. Nine out of 10 supplements revealed a detectable amount of T3 (1.3-25.4 μg/tablet) and 5 of 10 contained T4 (5.77-22.9 μg/tablet). Taken at the recommended dose, 5 supplements delivered T3 quantities of greater than 10 μg/day, and 4 delivered T4 quantities ranging from 8.57 to 91.6 μg/day. The majority of dietary thyroid supplements studied contained clinically relevant amounts of T4 and T3, some of which exceeded common treatment doses for hypothyroidism. These amounts of thyroid hormone, found in easily accessible dietary supplements, potentially expose patients to the risk of alterations in thyroid levels even to the point of developing iatrogenic thyrotoxicosis. The current study results emphasize the importance of patient and provider education regarding the use of dietary supplements and highlight the need for greater regulation of these products, which hold potential danger to public health.

Updates on chemical and biological research on botanical ingredients in dietary supplements.

PubMed

Pawar, Rahul S; Tamta, Hemlata; Ma, Jun; Krynitsky, Alexander J; Grundel, Erich; Wamer, Wayne G; Rader, Jeanne I

2013-05-01

Increased use of dietary supplements is a phenomenon observed worldwide. In the USA, more than 40% of the population recently reported using complementary and alternative medicines, including botanical dietary supplements. Perceptions that such dietary supplements are natural and safe, may prevent disease, may replace prescription medicines, or may make up for a poor diet, play important roles in their increased use. Toxicity of botanical dietary supplements may result from the presence of naturally occurring toxic constituents or from contamination or adulteration with pharmaceutical agents, heavy metals, mycotoxins, pesticides, or bacteria, misidentification of a plant species in a product, formation of electrophilic metabolites, organ-specific reactions, or botanical-drug interactions. The topics discussed in this review illustrate several issues in recent research on botanical ingredients in dietary supplements. These include (1) whether 1,3-dimethylamylamine is a natural constituent of rose geranium (Pelargonium graveolens), (2) how analysis of the components of dietary supplements containing bitter melon (Momordica charantia) is essential to understanding their potential biological effects, and (3) how evolving methods for in vitro studies on botanical ingredients can contribute to safety evaluations. The virtual explosion in the use of botanical ingredients in hundreds of products presents a considerable challenge to the analytical community, and the need for appropriate methods cannot be overstated. We review recent developments and use of newer and increasingly sensitive methods that can contribute to increasing the safety and quality of botanical ingredients in dietary supplements.

Why US children use dietary supplements

PubMed Central

Bailey, Regan L.; Gahche, Jaime J.; Thomas, Paul R.; Dwyer, Johanna T.

2013-01-01

Background: Dietary supplements are used by one-third of children. We examined motivations for supplement use in children, the types of products used by motivations, and the role of physicians and health care practitioners in guiding choices about supplements. Methods: We examined motivations for dietary supplement use reported for children (from birth to 19 y of age; n = 8,245) using the National Health and Nutrition Examination Survey 2007–2010. Results: Dietary supplements were used by 31% of children; many different reasons were given as follows: to “improve overall health” (41%), to “maintain health” (37%), for “supplementing the diet” (23%), to “prevent health problems” (20%), and to “boost immunity” (14%). Most children (~90%) who use dietary supplements use a multivitamin–mineral or multivitamin product. Supplement users tend to be non-Hispanic white, have higher family incomes, report more physical activity, and have health insurance. Only a small group of supplements used by children (15%) were based on the recommendation of a physician or other health care provider. Conclusion: Most supplements used by children are not under the recommendation of a health care provider. The most common reasons for use of supplements in children are for health promotion, yet little scientific data support this notion in nutrient-replete children. PMID:24002333

21 CFR 111.35 - Under this subpart D, what records must you make and keep?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... or dietary supplement; (ii) Calibrating, inspecting, and checking automated, mechanical, and... dietary supplements; (2) Documentation, in individual equipment logs, of the date of the use, maintenance...

21 CFR 111.15 - What sanitation requirements apply to your physical plant and grounds?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical... contamination of components, dietary supplements, or contact surfaces. The methods for adequate ground... constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are...

21 CFR 111.15 - What sanitation requirements apply to your physical plant and grounds?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical... contamination of components, dietary supplements, or contact surfaces. The methods for adequate ground... constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are...

21 CFR 111.35 - Under this subpart D, what records must you make and keep?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... or dietary supplement; (ii) Calibrating, inspecting, and checking automated, mechanical, and... dietary supplements; (2) Documentation, in individual equipment logs, of the date of the use, maintenance...

Dietary Supplements and Sports Performance: Amino Acids

PubMed Central

Williams, Melvin

2005-01-01

This is the third in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance. PMID:18500957

76 FR 11502 - Notice of Vitamin D Standardization Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... Standardization Program SUMMARY: The Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH... FURTHER INFORMATION CONTACT: Ms. Cindy Rooney, Office of Dietary Supplements, National Institutes of... Dietary Supplements, Office of the Director, National Institutes of Health. [FR Doc. 2011-4603 Filed 3-1...

77 FR 28604 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-15

... Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act... Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' DATES: Submit either electronic or... Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement...

75 FR 4079 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

... Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and... and clearance. Food Labeling; Notification Procedures for Statements on Dietary Supplements--21 CFR...)) requires that the agency be notified by manufacturers, packers, and distributors of dietary supplements...

76 FR 37124 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... Dietary Supplements During an Influenza Pandemic; Availability AGENCY: Food and Drug Administration, HHS... Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability--(OMB...

ENVIRONMENTAL CONTAMINANTS AND POTENTIAL HUMAN RISK ASSOCIATED WITH SELECTED BOTANICAL DIETARY SUPPLEMENTS

EPA Science Inventory

Botanical dietary supplements have a long history of use in Europe and China and they are becoming increasingly popular in the United States. However, little data is available regarding environmental contaminants in botanical dietary supplements and the risk posed to those ingest...

Dietary supplement intake during pregnancy; better safe than sorry?

PubMed

de Boer, Alie; Bast, Aalt; Godschalk, Roger

2018-06-01

Consumption of dietary supplements and specifically niche products such as supplements targeting pregnant women is increasing. The advantages of dietary supplementation during pregnancy with folic acid have been established, but health effects of many other supplements have not been confirmed. EU and US legislation on dietary supplements requires the product to be safe for the direct consumer, the mother. Long-term health effects for the fetus due to fetal programming (in utero adaptation of the fetal epigenome due to environmental stimuli such as supplementation) are not taken into account. Such epigenetic alterations can, however, influence the response to health challenges in adulthood. We therefore call for both conducting research in birth cohorts and animal studies to identify potential health effects in progeny of supplement consuming mothers as well as the establishment of a nutrivigilance scheme to identify favorable and adverse effects post-marketing. The acquired knowledge can be used to create more effective legislation on dietary supplement intake during pregnancy for safety of the child. Increasing knowledge on the effects of consuming supplements will create a safer environment for future mothers and their offspring to optimize their health before, during and after pregnancy. Copyright © 2018 Elsevier Inc. All rights reserved.

Reducing heart disease through the vegetarian diet using primary prevention.

PubMed

Sticher, Megan A; Smith, Christine B; Davidson, Susan

2010-03-01

To evaluate research on the vegetarian diet for its safety, effectiveness in reducing heart disease, special considerations, contraindications, and its association with decreased cardiovascular disease risk. Selected research and evidence-based dietary guidelines found by searching CINAHL, PubMed, Ovid databases, and the World Wide Web. A carefully planned vegetarian diet with adequate supplementation may be effective for primary prevention of heart disease. The vegetarian diet is cost effective, safe, and relatively easy to implement. Improved dietary choices can help improve many chronic conditions. Guidelines for proper nutrition within a vegetarian lifestyle are readily accessible to patients and professionals alike. Referral to a dietitian is an appropriate option in primary care settings.

Using 2 Assessment Methods May Better Describe Dietary Supplement Intakes in the United States123

PubMed Central

Nicastro, Holly L; Bailey, Regan L; Dodd, Kevin W

2015-01-01

Background: One-half of US adults report using a dietary supplement. NHANES has traditionally assessed dietary supplement use via a 30-d questionnaire but in 2007 added a supplement module to the 24-h dietary recall (24HR). Objective: We compared these 2 dietary assessment methods, examined potential biases in the methods, and determined the effect that instrument choice had on estimates of prevalence of multivitamin/multimineral dietary supplement (MVMM) use. Methods: We described prevalence of dietary supplement use by age, sex, and assessment instrument in 12,285 adults in the United States (>19 y of age) from NHANES 2007–2010. Results: When using data from the questionnaire alone, 29.3% ± 1.0% of men and 35.5% ± 1.0% of women were users of MVMMs, whereas data from the 24HR only produced prevalence estimates of 26.3% ± 1.1% for men and 33.2% ± 1.0% for women. When using data from both instruments combined, 32.3% ± 1.2% of men and 39.5% ± 1.1% of women were classified as MVMM users. Prevalence estimates were significantly higher by 2–9% in all age–sex groups when using information from both instruments combined than when using data from either instrument individually. A digit preference bias and flattened slope phenomenon were observed in responses to the dietary supplement questionnaire. A majority (67%) of MVMMs were captured on both instruments, whereas 19% additional MVMMs were captured on the questionnaire and 14% additional on the 24HR. Of those captured only on the 24HR, 26% had missing label information, whereas only 12% and 9% of those captured on the questionnaire or both, respectively, had missing information. Conclusions: Use of both the dietary supplement questionnaire and the 24HR can provide advantages to researchers over the use of a single instrument and potentially capture a larger fraction of dietary supplement users. PMID:26019244

Using 2 Assessment Methods May Better Describe Dietary Supplement Intakes in the United States.

PubMed

Nicastro, Holly L; Bailey, Regan L; Dodd, Kevin W

2015-07-01

One-half of US adults report using a dietary supplement. NHANES has traditionally assessed dietary supplement use via a 30-d questionnaire but in 2007 added a supplement module to the 24-h dietary recall (24HR). We compared these 2 dietary assessment methods, examined potential biases in the methods, and determined the effect that instrument choice had on estimates of prevalence of multivitamin/multimineral dietary supplement (MVMM) use. We described prevalence of dietary supplement use by age, sex, and assessment instrument in 12,285 adults in the United States (>19 y of age) from NHANES 2007-2010. When using data from the questionnaire alone, 29.3% ± 1.0% of men and 35.5% ± 1.0% of women were users of MVMMs, whereas data from the 24HR only produced prevalence estimates of 26.3% ± 1.1% for men and 33.2% ± 1.0% for women. When using data from both instruments combined, 32.3% ± 1.2% of men and 39.5% ± 1.1% of women were classified as MVMM users. Prevalence estimates were significantly higher by 2-9% in all age-sex groups when using information from both instruments combined than when using data from either instrument individually. A digit preference bias and flattened slope phenomenon were observed in responses to the dietary supplement questionnaire. A majority (67%) of MVMMs were captured on both instruments, whereas 19% additional MVMMs were captured on the questionnaire and 14% additional on the 24HR. Of those captured only on the 24HR, 26% had missing label information, whereas only 12% and 9% of those captured on the questionnaire or both, respectively, had missing information. Use of both the dietary supplement questionnaire and the 24HR can provide advantages to researchers over the use of a single instrument and potentially capture a larger fraction of dietary supplement users. © 2015 American Society for Nutrition.

Concomitant use of prescription medications and dietary supplements in menopausal women; an approach to provider preparedness

PubMed Central

Gardiner, Paula; Stargrove, Mitchell Bebel; Dog, Tieraona Low

2010-01-01

Dietary supplements are becoming increasingly popular as therapies for symptom relief among menopause-age women in the United States. However, a large gap exists between research in the concomitant use of prescription medications and dietary supplements and provider preparedness to guide patient decision making. Many menopausal women take prescription medications, over the counter medications, and herbs and dietary supplements for climactic symptoms or other health conditions. With any drug, there is the potential for interactions. Women taking medications with a narrow therapeutic index, such as anticoagulants, anticonvulsants, and drugs for the treatment of chronic diseases, are at particular risk. Patients should be queried regarding their use of dietary supplements when starting or stopping a prescription drug, or if unexpected reactions occur. When counseling patients, one must carefully consider the risks and benefits of each supplement and medication being taken by each individual. PMID:21168291

Lipid lowering with dietary supplements: focus on diabetes.

PubMed

Rudkowska, Iwona

2012-06-01

Cardiovascular disease (CVD) is the predominant cause of mortality in type 2 diabetic (T2DM) patients. Dyslipidemia is a modifiable risk factor that should be treated early for CVD prevention. Further, dietary supplement intake is increasing in popularity worldwide. This review examines the recent meta-analyses and clinical studies on dietary supplements, specifically psyllium, garlic and green tea, on plasma lipids levels and glycemic control, as well as other potential CVD risk factors in T2DM patients. Generally, results demonstrate that psyllium supplements improve lipid profiles as well as glycemic control beyond a traditional diet in patients with T2DM. On the other hand, the results on the usefulness of garlic and green tea supplementation for dyslipidemia and hyperglycemia are uncertain. Overall, the addition of dietary supplements may be a therapeutic alternative to lower CVD risk factors in T2DM; however, more well-designed intervention studies are needed to assess the benefit of these dietary supplements. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Prevalence of dietary supplement use and associated factors among female college students in Saudi Arabia.

PubMed

Alfawaz, Hanan; Khan, Nasiruddin; Alfaifi, Aziza; Shahrani, Fatima M; Al Tameem, Huda M; Al Otaibi, Seetah F; Abudigin, Weaam I; Al-Shayaa, Mohammad S; Al-Ghanim, Saad A; Al-Daghri, Nasser M

2017-11-22

The economic boom in Saudi Arabia indirectly prompted the use of dietary supplements in the last two decades. Our aim is to investigate the prevalence of dietary supplement use and its association with sociodemographic/lifestyle characteristics among Saudi female students. In this cross-sectional study, 534 female participants (≥19 years of age) completed a self-administered questionnaire that include sociodemographic and lifestyle characteristics, perceived health status, dietary supplement use, general awareness, attitudes and behavior. In all participants, the prevalence of dietary supplement use was 76.6% (n = 409). High level of education (p = 0.002) and more physical activity (p = 0.008) exhibited a significant positive association with users than to non-users. The frequency showed that beta-carotene (54.2%), chamomile (54.2%), and glucosamine (53.8%) were the most preferred diet supplements under the category "when needed". Cod liver oil (71.3%), omega 3 (68.3%), multi-vitamins (61.5%), ginseng (60%), and vitamin A (60%), were mostly used "from time to time". Multi-minerals (34.4%) were the preferred choice when it comes to daily use. The main reasons for supplement use were to "maintain healthy hair" and "injury and illness" (both 26.2%). About 38.4% were not aware and 30.3% disagree on differences taking supplements with or without consulting a medical professional. About 36.7% lack information about side effects while, 35.0% were unaware about any health effect of dietary supplements. The prevalence of dietary supplement use was high in Saudi female students and was significantly associated with sociodemographic and lifestyle factors.

Use of dietary supplements by pregnant and lactating women in North America1234

PubMed Central

Picciano, Mary Frances; McGuire, Michelle K

2009-01-01

Nutrient requirements increase during periods of growth and development such as pregnancy and lactation. In response, many clinicians recommend dietary supplements during these important periods of the life cycle. Although there exist some recommendations concerning the need for a limited number of nutrients in supplemental form (eg, iron, folic acid, and iodine), there is a relative paucity of data concerning the use of dietary supplements during pregnancy and lactation. Limited data suggest, however, that usage is dependent on demographic, sociologic, and economic factors. Thus, it is possible that the nation's most at-risk populations may be those who are least likely to comply with these recommendations. As researchers continue to study what is meant by “optimal nutrition” during pregnancy and lactation, it is likely that additional recommendations concerning dietary supplements will emerge. For example, it is possible that increased consumption of some of the long-chain polyunsaturated fatty acids during pregnancy or lactation may impart a benefit to infant health. Understanding better the population dynamics related to supplement use during these periods will be critical in implementation of campaigns designed to encourage appropriate use—and discourage inappropriate use—of dietary supplements during these important phases of human reproduction. The purpose of this article is to briefly review what is known about the use of dietary supplements in North America and, more specifically, in pregnant and lactating women. In addition, information concerning barriers to supplement use is discussed as are current recommendations for dietary supplement consumption during these periods of the life cycle. PMID:19073789

21 CFR 111.27 - What requirements apply to the equipment and utensils that you use?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... contamination of components or dietary supplements with: (i) Lubricants; (ii) Fuel; (iii) Coolants; (iv) Metal... equipment or utensils contact components or dietary supplements; (iii) Made of nontoxic materials; (iv...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.3 - What definitions apply to this part?

Code of Federal Regulations, 2012 CFR

2012-04-01

..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.3 What definitions apply to... appropriate step of manufacture or packaging of a particular dietary supplement. Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity...

21 CFR 111.20 - What design and construction requirements apply to your physical plant?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... use in the manufacture, packaging, labeling, or holding of dietary supplements must: (a) Be suitable... dietary supplements during manufacturing, packaging, labeling, or holding; (c) Permit the use of proper...

21 CFR 111.27 - What requirements apply to the equipment and utensils that you use?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... contamination of components or dietary supplements with: (i) Lubricants; (ii) Fuel; (iii) Coolants; (iv) Metal... equipment or utensils contact components or dietary supplements; (iii) Made of nontoxic materials; (iv...

21 CFR 111.10 - What requirements apply for preventing microbial contamination from sick or infected personnel...

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR DIETARY SUPPLEMENTS Personnel § 111.10 What requirements apply for preventing microbial... components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. Such measures include the following: (1) Excluding from working in any...

21 CFR 111.3 - What definitions apply to this part?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.3 What definitions apply to... appropriate step of manufacture or packaging of a particular dietary supplement. Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity...

21 CFR 111.10 - What requirements apply for preventing microbial contamination from sick or infected personnel...

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR DIETARY SUPPLEMENTS Personnel § 111.10 What requirements apply for preventing microbial... components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. Such measures include the following: (1) Excluding from working in any...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.20 - What design and construction requirements apply to your physical plant?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... use in the manufacture, packaging, labeling, or holding of dietary supplements must: (a) Be suitable... dietary supplements during manufacturing, packaging, labeling, or holding; (c) Permit the use of proper...

Marketplace analysis demonstrates quality control standards needed for black raspberry dietary supplements

USDA-ARS?s Scientific Manuscript database

There is currently no standard for the minimum anthocyanin concentration a black raspberry dietary supplement must contain for legal sale in the US. All consumer available black raspberry products (n=19), packaged as dietary supplements or otherwise prepared (freeze-dried whole and pre-ground powder...

ENVIRONMENTAL CONTAMINANTS IN BOTANICAL DIETARY SUPPLEMENT GINSENG AND POTENTIAL HUMAN HEALTH

EPA Science Inventory

Botanical dietary supplements have a long history of use in Europe and Asia, but the use of these products is becoming increasingly popular in the United States. Because these products are classified as dietary supplements, the U.S. Food and Drug Administration does not routinely...

77 FR 43841 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

... Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and... Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer... the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat...

76 FR 49707 - Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

...; (8) allow for the use of the health claim on phytosterol ester-containing dietary supplements (esterified with food- grade fatty acids) but not on nonesterified phytosterol-containing dietary supplements... regarding the cholesterol- lowering efficacy of nonesterified phytosterols in dietary supplements. FDA did...

77 FR 14021 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

...; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and... that a collection of information entitled ``Substantiation for Dietary Supplement Claims Made Under the... collection of information entitled '' Substantiation for Dietary Supplement Claims Made Under the Federal...

Prevalence and predictors of children's dietary supplement use: the 2007 National Health Interview Survey

USDA-ARS?s Scientific Manuscript database

Little is known about the characteristics of US children who are dietary supplement users. We described the prevalence and predictors of and reasons for giving children dietary supplements. The study included children <18 y of age who participated in the Complementary and Alternative Medicine supple...

Use of nutrient self selection as a diet refining tool in Tenebrio molitor (Coleoptera: Tenebrionidae)

USDA-ARS?s Scientific Manuscript database

A new method to refine existing dietary supplements for improving production of the yellow mealworm, Tenebrio molitor L. (Coleoptera: Tenebrionidae), was tested. Self selected ratios of 6 dietary ingredients by T. molitor larvae were used to produce a dietary supplement. This supplement was compared...

A review of the effects of vitamins and other dietary supplements on seizure activity.

PubMed

Lee, Susan W; Chung, Steve S

2010-07-01

The role of pharmacological and surgical management of epilepsy continues to expand, but these treatments are often associated with significant side effects and morbidity. As a result, many patients with epilepsy and their physicians alike have gained interest in the role of vitamins and other dietary supplements for seizure management. In this review, we examine the potential anticonvulsant and proconvulsant effects of commonly used dietary supplements, as well as their potential effects on cognition or behavior. Our review was conducted through a literature search focusing on clinical trials involving patients with epilepsy and their seizure response to dietary supplementation. We summarize findings from previous clinical studies and comment on practical considerations regarding dietary supplementation for patients with epilepsy. Copyright 2010 Elsevier Inc. All rights reserved.

Dietary Supplements Commonly Used by Cancer Survivors: Are There Any Benefits?

PubMed

Marian, Mary J

2017-10-01

Following a cancer diagnosis, dietary supplements are reportedly used by 20%-80% of individuals. Supplements are most commonly used by breast cancer survivors, followed by patients with prostate, colorectal, and lung cancers, which is not surprising since these are the most common types of cancer diagnosed in adults. Reasons cited for such use include improving quality of life, reducing symptoms related to treatment and/or the disease process, and recommendation from medical practitioners; family and friends may also be an influence. However, controversy surrounds the use of dietary supplements, particularly during treatment-specifically, whether supplements affect treatment efficacy is unknown. This article discusses the evidence related to common dietary supplements used to prevent cancer or a recurrence.

Dietary supplement usage, motivation, and education in young, Canadian athletes.

PubMed

Wiens, Kristin; Erdman, Kelly Anne; Stadnyk, Megan; Parnell, Jill A

2014-12-01

To evaluate dietary supplement use in young Canadian athletes, their motivation for consuming supplements, and their sources of information. A questionnaire tested for content validity and reliability was administered to 567 athletes between the ages of 11 and 25 years from the Canadian athletic community in face-to-face meetings. Demographics and sport variables were analyzed using descriptive statistics. Fisher's exact tests were used to examine dietary supplementation patterns and sources of information regarding dietary supplement use between categories of gender, age, sport type, and competition level. Ninety-eight percent of athletes were taking at least one dietary supplement. Males were more likely to consume protein powder, energy drinks, recovery drinks, branched chain amino acids, beta-alanine, and glutamine (p < .01); supplements typically associated with increased muscle mass. Athletes 11-17 years old focused on vitamin and mineral supplements; whereas, athletes 18-25 years old focused on purported ergogenic supplements. Strength training athletes were more likely to consume creatine, glutamine, and protein powders (p < .02). Reasons for supplement use included to stay healthy, increase energy, immune system, recovery, and overall performance. Primary sources of information were family and friends, coaches, and athletic trainers; with 48% of athletes having met with a dietitian. Preferred means of education included individual consultations, presentations, and the internet. The majority of young athletes are using dietary supplements with the belief they will improve performance and health; however, may not always have reliable information. Educational programs using individual consultations and electronic media are recommended for this demographic.

Micronutrient Intakes in 553 Dutch Elite and Sub-Elite Athletes: Prevalence of Low and High Intakes in Users and Non-Users of Nutritional Supplements

PubMed Central

Wardenaar, Floris; Brinkmans, Naomi; Ceelen, Ingrid; Van Rooij, Bo; Mensink, Marco; Witkamp, Renger; De Vries, Jeanne

2017-01-01

This study investigated whether athletes meet micronutrient recommendations and whether the adequacy of their intake is related to the use of dietary supplements, sport nutrition products or a combination. Micronutrient intakes of 553 Dutch (sub-) elite athletes were assessed using web-based 24-h dietary recalls with accompanying nutritional supplement questionnaires. In the majority of both users and non-users of dietary supplements, vitamin D intake was below the estimated average requirement (AR) if supplements were not included in the analysis. Including dietary supplements improved vitamin D intake, but still a part of the athletes, both men and women, reported an intake below the AR. Non-users of dietary supplements were particularly at risk for low intakes of vitamins B1, B2, B3 and vitamins A, C and selenium. Mean iron intake was reported below the AR in a substantial group of women, both users and non-users. The use of sport nutrition products contributed only slightly to micronutrient intake. A small prevalence of athletes using dietary supplements showed intakes of some micronutrients above the Upper Level. In conclusion, both users and non-users of nutritional supplements reported inadequate intake of micronutrients. For most micronutrients, use of nutritional supplements does not completely compensate for intakes below AR. Athletes should consider making better food choices and the daily use of a low-dosed multivitamin supplement. PMID:28212284

Botanical and Dietary Supplements for Menopausal Symptoms: What Works, What Doesn’t

PubMed Central

Geller, Stacie E.; Studee, Laura

2006-01-01

All women reach menopause and approximately two-thirds of women develop menopausal symptoms, primarily hot flashes. Hormone therapy long was considered the first line of treatment for vasomotor symptoms. However, given the results of the Women’s Health Initiative, many women are reluctant use exogenous hormones for symptomatic treatment and are turning to botanicals and dietary supplement (BDS) products for relief. Despite the fact that there is limited scientific evidence describing efficacy and long term safety of such products, many women find these “natural treatments” appealing. Peri- and postmenopausal women are amongst the highest users of these products, but 70% of women do not tell their health care providers about their use. Compounding this issue is the fact that few clinicians ask their patients about use of BDS, largely because they have not been exposed to alternative medical practices in their training and are unfamiliar with these products. This paper reviews the botanicals and dietary supplements commonly used in menopause, (such as black cohosh, red clover, soy products, among others) as well as the available data on efficacy and safety. We searched the MEDLINE database from 1966 to December 2004 using terms related to botanical and dietary supplements and menopausal symptoms for peri- or postmenopausal women. Abstracts from relevant meetings as well as reference books and websites on herbal supplements were also searched. Randomized-controlled trials (RCTs) were used if available; open trials and comparison group studies were used when RCTs were not available. The evidence to date suggests that black cohosh is safe and effective for reducing menopausal symptoms, primarily hot flashes and possibly mood disorders. Phytoestrogen extracts, including soy foods and red clover appear to have at best only minimal effect on menopausal symptoms but have positive health effects on plasma lipid concentrations and may reduce heart disease. St. John’s wort has been shown to improve mild to moderate depression in the general population and appears to show efficacy for mood disorders related to the menopausal transition. Other commonly used botanicals have limited evidence to demonstrate safety and efficacy for relief of symptoms related to menopause. PMID:16181020

Nutraceuticals with a clinically detectable blood pressure-lowering effect: a review of available randomized clinical trials and their meta-analyses.

PubMed

Borghi, Claudio; Cicero, Arrigo F G

2017-01-01

The aim of the present study was to review and comment on the available evidence on nutraceuticals with a clinically demonstrable blood pressure (BP)-lowering effect. We reviewed studies published in the English language from 1990 to 2015 on dietary supplements or nutraceuticals claiming to show an effect on human BP. An initial list of possibly effective agents and studies was obtained from the online reference, the Natural Medicine Comprehensive Database. Using PubMed, we searched agents identified from this list using the MeSH terms 'hypertension', 'blood pressure', 'dietary supplement' and 'nutraceuticals', alone and in combination. We then focused our attention on meta-analyses and randomized clinical trials. Beyond the well-known effects on BP of the Dietary Approaches to Stop Hypertension (DASH) and the Mediterranean diet, a large number of studies have investigated the possible BP-lowering effect of different dietary supplements and nutraceuticals, most of which are antioxidant agents with a high tolerability and safety profile. In particular, a relatively large body of evidence supports the use of potassium, magnesium, L-arginine, vitamin C, cocoa flavonoids, beetroot juice, coenzyme Q10, controlled-release melatonin and aged garlic extract. The antihypertensive effect of all these nutraceuticals seems to be dose related and the overall tolerability is good. Some nutraceuticals might have a positive impact on BP in humans. Further clinical research is needed, to identify from the available active nutraceuticals those with the best cost-effectiveness and risk-benefit ratio for widespread and long-term use in the general population with a low-added cardiovascular risk related to uncomplicated hypertension. © 2016 The British Pharmacological Society.

Dietary changes and dietary supplement use, and underlying motives for these habits reported by colorectal cancer survivors of the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry.

PubMed

Bours, Martijn J; Beijer, Sandra; Winkels, Renate M; van Duijnhoven, Fränzel J; Mols, Floortje; Breedveld-Peters, José J; Kampman, Ellen; Weijenberg, Matty P; van de Poll-Franse, Lonneke V

2015-07-01

In the present study, we aimed to describe dietary changes made post-diagnosis and current dietary supplement use by survivors of colorectal cancer (CRC), and explore the underlying motives for these lifestyle habits. Cross-sectional analyses were performed for 1458 stage I-IV CRC survivors of the Patient Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry, diagnosed between 2000 and 2009. Lifestyle, sociodemographic and clinical information was collected. Prevalence of and motivations for dietary changes and supplement use were assessed. Associations between lifestyle, sociodemographic and clinical variables were analysed by multivariable logistic regression. CRC survivors (57% male) were on average 70 (SD 9) years of age and diagnosed 7 (SD 3) years ago. Dietary changes post-diagnosis were reported by 36% of the survivors and current supplement use by 32%. Motivations for dietary changes were mostly cancer-related (44% reported 'prevention of cancer recurrence' as the main reason), while motivations for supplement use were less frequently related to the cancer experience (38% reported 'to improve health and prevent disease in general' as the main reason). Dietary changes were significantly associated with dietary supplement use (OR 1.5, 95% CI 1.1, 2.1). Survivors who had received dietary advice, were non-smokers, under 65 years of age, and had no stoma were more likely to have changed their diet. Survivors who were female, had multiple co-morbidities, and no overweight or obesity were more likely to use supplements. In conclusion, many CRC survivors alter their diet post-diagnosis and use dietary supplements, in part for different reasons. Insights into motivations behind these lifestyle habits and characteristics of CRC survivors adopting these habits can improve the tailoring of lifestyle counselling strategies.

Executive summary: conference on Dietary Supplement Use in the Elderly--proceedings of the conference held January 14-15, 2003, Natcher Auditorium, National, Institutes of Health, Bethesda, MD.

PubMed

2004-04-01

Several issues prompted the need for this conference. Among these were the reported high prevalence (> 50%) of use of supplements among individuals over 50 years of age, inadequate scientific evidence supporting the safety and benefits of use among these individuals, and a report issued by the General Accounting Office (GAO) in 2001. This GAO report entitled "Health Products for Seniors: 'Anti-Aging' Products Pose Potential for Physical and Economic Harm," arose from concerns among legislators that seniors were spending money from their limited incomes on products that were not only ineffective but also potentially harmful. The conference was organized around three sessions to address the issues highlighted above, which were usage of dietary supplements among the elderly, age-related changes and issues that affect the use of supplements, and the evidence base supporting the use of supplements in disease prevention and health maintenance. Each session was followed by a panel discussion. This Executive Summary is organized around the three major discussion topics. The summary does not explicitly follow the order of the conference presentations; rather it is intended to capture and examine the current research gaps in knowledge and identify future research opportunities. These research opportunities, as expressed by the conference speakers, panelists, and attendees are summarized at the end of this paper under five thematic areas: usage behaviors, methodology, pre-clinical studies and clinical studies, informational databases, and education and dissemination.

Herbal hepatotoxicity: suspected cases assessed for alternative causes.

PubMed

Teschke, Rolf; Schulze, Johannes; Schwarzenboeck, Alexander; Eickhoff, Axel; Frenzel, Christian

2013-09-01

Alternative explanations are common in suspected drug-induced liver injury (DILI) and account for up to 47.1% of analyzed cases. This raised the question of whether a similar frequency may prevail in cases of assumed herb-induced liver injury (HILI). We searched the Medline database for the following terms: herbs, herbal drugs, herbal dietary supplements, hepatotoxic herbs, herbal hepatotoxicity, and herb-induced liver injury. Additional terms specifically addressed single herbs and herbal products: black cohosh, Greater Celandine, green tea, Herbalife products, Hydroxycut, kava, and Pelargonium sidoides. We retrieved 23 published case series and regulatory assessments related to hepatotoxicity by herbs and herbal dietary supplements with alternative causes. The 23 publications comprised 573 cases of initially suspected HILI; alternative causes were evident in 278/573 cases (48.5%). Among them were hepatitis by various viruses (9.7%), autoimmune diseases (10.4%), nonalcoholic and alcoholic liver diseases (5.4%), liver injury by comedication (DILI and other HILI) (43.9%), and liver involvement in infectious diseases (4.7%). Biliary and pancreatic diseases were frequent alternative diagnoses (11.5%), raising therapeutic problems if specific treatment is withheld; pre-existing liver diseases including cirrhosis (9.7%) were additional confounding variables. Other diagnoses were rare, but possibly relevant for the individual patient. In 573 cases of initially assumed HILI, 48.5% showed alternative causes unrelated to the initially incriminated herb, herbal drug, or herbal dietary supplement, calling for thorough clinical evaluations and appropriate causality assessments in future cases of suspected HILI.

Dietary supplements and team-sport performance.

PubMed

Bishop, David

2010-12-01

A well designed diet is the foundation upon which optimal training and performance can be developed. However, as long as competitive sports have existed, athletes have attempted to improve their performance by ingesting a variety of substances. This practice has given rise to a multi-billion-dollar industry that aggressively markets its products as performance enhancing, often without objective, scientific evidence to support such claims. While a number of excellent reviews have evaluated the performance-enhancing effects of most dietary supplements, less attention has been paid to the performance-enhancing claims of dietary supplements in the context of team-sport performance. Dietary supplements that enhance some types of athletic performance may not necessarily enhance team-sport performance (and vice versa). Thus, the first aim of this review is to critically evaluate the ergogenic value of the most common dietary supplements used by team-sport athletes. The term dietary supplements will be used in this review and is defined as any product taken by the mouth, in addition to common foods, that has been proposed to have a performance-enhancing effect; this review will only discuss substances that are not currently banned by the World Anti-Doping Agency. Evidence is emerging to support the performance-enhancing claims of some, but not all, dietary supplements that have been proposed to improve team-sport-related performance. For example, there is good evidence that caffeine can improve single-sprint performance, while caffeine, creatine and sodium bicarbonate ingestion have all been demonstrated to improve multiple-sprint performance. The evidence is not so strong for the performance-enhancing benefits of β-alanine or colostrum. Current evidence does not support the ingestion of ribose, branched-chain amino acids or β-hydroxy-β-methylbutyrate, especially in well trained athletes. More research on the performance-enhancing effects of the dietary supplements highlighted in this review needs to be conducted using team-sport athletes and using team-sport-relevant testing (e.g. single- and multiple-sprint performance). It should also be considered that there is no guarantee that dietary supplements that improve isolated performance (i.e. single-sprint or jump performance) will remain effective in the context of a team-sport match. Thus, more research is also required to investigate the effects of dietary supplements on simulated or actual team-sport performance. A second aim of this review was to investigate any health issues associated with the ingestion of the more commonly promoted dietary supplements. While most of the supplements described in the review appear safe when using the recommended dose, the effects of higher doses (as often taken by athletes) on indices of health remain unknown, and further research is warranted. Finally, anecdotal reports suggest that team-sport athletes often ingest more than one dietary supplement and very little is known about the potential adverse effects of ingesting multiple supplements. Supplements that have been demonstrated to be safe and efficacious when ingested on their own may have adverse effects when combined with other supplements. More research is required to investigate the effects of ingesting multiple supplements (both on performance and health).

Development of Dietary Polyphenol Preparations for Treating Veterans with Gulf War Illness

DTIC Science & Technology

2015-10-01

chronic fatigue. We hypothesized that dietary supplementation with a Flavonoid- Rich Preparation (FRP), a combination of Concord Grape Juice (CGJ...We propose to test the feasibility of dietary supplementation with FRP in Veterans with GWI, and to gather evidence supporting the efficacy of FRP...fatigue and preserve against cognitive functions. Based on this, our overall goal is to test the potential efficacy of dietary supplementation with a

Dietary supplement adverse events: report of a one-year poison center surveillance project.

PubMed

Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

2008-06-01

The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

Use of dietary supplements by elite figure skaters.

PubMed

Ziegler, Paula J; Nelson, Judy A; Jonnalagadda, Satya S

2003-09-01

The present study examined the prevalence of dietary supplement use among elite figure skaters, gender differences in supplement use, and differences in nutrient intake of supplement users versus non-users. Male (n = 46) and female (n = 59) figure skaters completed a supplement survey and 3-day food records. Descriptive analysis, chi-square test, and independent t tests were used to analyze the data. Sixty-five percent of male (n = 30) and 76% of female (n = 45) figure skaters reported use of supplements. Forty-seven percent of males and 55% of females reported daily use of supplements. Multivitamin-mineral supplements were the most popular dietary supplements consumed by figure skaters. Significant gender differences were observed in the use of multivitamin-mineral supplements (61% males vs. 83% females, p < .05). Echinacea and ginseng were popular herbal supplements used by these skaters. The 3 main reasons given by male figure skaters for taking supplements were: to provide more energy (41%), to prevent illness or disease (34%), and to enhance performance (21%). Among female figure skaters, the 3 main reasons given were: to prevent illness or disease (61%), to provide more energy (39%), and to make up for an inadequate diet (28%). Significant differences (p < .05) were observed in protein, total fat, saturated fat, polyunsaturated fat intakes, and % energy from carbohydrate and total fat of male supplement users versus non-users, with supplement users having higher intakes except for percent energy from carbohydrate. Sodium was the only nutrient significantly different (p < .05) among female supplement users versus non-users, with supplement users having lower intakes. Given the popularity of dietary supplements, it is important to understand the factors influencing athletes' use of supplements, their knowledge and attitudes regarding supplements, dosage of supplements used, and the effectiveness of these dietary supplements in meeting the goals of the athletes.

Effects of dietary L-glutamine supplementation on specific and general defense responses in mice immunized with inactivated Pasteurella multocida vaccine.

PubMed

Chen, Shuai; Liu, Shuping; Zhang, Fengmei; Ren, Wenkai; Li, Nengzhang; Yin, Jie; Duan, Jielin; Peng, Yuanyi; Liu, Gang; Yin, Yulong; Wu, Guoyao

2014-10-01

Little is known about effects of dietary glutamine supplementation on specific and general defense responses in a vaccine-immunized animal model. Thus, this study determined roles for dietary glutamine supplementation in specific and general defense responses in mice immunized with inactivated Pasteurella multocida vaccine. The measured variables included: (1) the production of pathogen-specific antibodies; (2) mRNA levels for pro-inflammatory cytokines, toll-like receptors and anti-oxidative factors; and (3) the distribution of P. multocida in tissues and the expression of its major virulence factors in vivo. Dietary supplementation with 0.5 % glutamine had a better protective role than 1 or 2 % glutamine against P. multocida infection in vaccine-immunized mice, at least partly resulting from its effects in modulation of general defense responses. Dietary glutamine supplementation had little effects on the production of P. multocida-specific antibodies. Compared to the non-supplemented group, dietary supplementation with 0.5 % glutamine had no effect on bacterial burden in vivo but decreased the expression of major virulence factors in the spleen. Collectively, supplementing 0.5 % glutamine to a conventional diet provides benefits in vaccine-immunized mice by enhancing general defense responses and decreasing expression of specific virulence factors.

Quality assurance issues in the use of dietary supplements, with special reference to protein supplements.

PubMed

Maughan, Ronald J

2013-11-01

The use of dietary supplements is widespread in the general population, in athletes and recreational exercisers, and in military personnel. A wide array of supplements is available, but protein-containing products are consistently among the most popular, especially among those who engage in resistance training. There are significant risks associated with the use of unregulated dietary supplements. Risks include the absence of active ingredients, the presence of harmful substances (including microbiological agents and foreign objects), the presence of toxic agents, and the presence of potentially dangerous prescription-only pharmaceuticals. There is ample evidence of athletes who have failed doping tests because of the use of dietary supplements. There is also growing evidence of risks to health and of serious adverse events, including a small number of fatalities, as a result of supplement use. The risk associated with the use of protein powders produced by major manufacturers is probably low, and the risk can be further reduced by using only products that have been tested under one of the recognized supplement quality assurance programs that operate in various countries. Nevertheless, a small risk remains, and athletes, soldiers, and other consumers should conduct a cost-benefit analysis before using any dietary supplements.

Dietary supplements and disease prevention - a global overview.

PubMed

Rautiainen, Susanne; Manson, JoAnn E; Lichtenstein, Alice H; Sesso, Howard D

2016-07-01

Dietary supplements are widely used and offer the potential to improve health if appropriately targeted to those in need. Inadequate nutrition and micronutrient deficiencies are prevalent conditions that adversely affect global health. Although improvements in diet quality are essential to address these issues, dietary supplements and/or food fortification could help meet requirements for individuals at risk of deficiencies. For example, supplementation with vitamin A and iron in developing countries, where women of reproductive age, infants and children often have deficiencies; with folic acid among women of reproductive age and during pregnancy; with vitamin D among infants and children; and with calcium and vitamin D to ensure bone health among adults aged ≥65 years. Intense debate surrounds the benefits of individual high-dose micronutrient supplementation among well-nourished individuals because the alleged beneficial effects on chronic diseases are not consistently supported. Daily low-dose multivitamin supplementation has been linked to reductions in the incidence of cancer and cataracts, especially among men. Baseline nutrition is an important consideration in supplementation that is likely to modify its effects. Here, we provide a detailed summary of dietary supplements and health outcomes in both developing and developed countries to help guide decisions about dietary supplement recommendations.

Using the theory of planned behavior to explore attitudes and beliefs about dietary supplements among HIV-positive Black women.

PubMed

Lino, Stephanie; Marshak, Helen Hopp; Herring, R Patti; Belliard, Juan Carlos; Hilliard, Charles; Campbell, Danielle; Montgomery, Susanne

2014-04-01

This cross-sectional study investigated whether the theory of planned behavior (TPB) constructs: attitudes, subjective norms, and perceived behavioral control were related to intention of dietary supplements use among African-American women living with Human Immunodeficiency Virus and/or Acquired Immune Deficiency Syndrome (HIV/AIDS). A closed-ended questionnaire based on the TPB was utilized to explore the use of dietary supplements among a cohort of 153 HIV-positive African-American women. Overall, 45% of the respondents used dietary supplements to manage/control their HIV. Combined, attitudes, subjective norms and perceived behavioral control were significant predictors of intention toward dietary supplement use (69% of the variance explained, p<0.0001). Attitudes (β=0.23, p<0.001) and perceived behavioral control (β=0.45, p<0.0001) were found to be significant independent predictors of intention. Behavioral intention and proximal TPB constructs (attitudes, subjective norms, and perceived behavioral control), as well as their underlying beliefs about dietary supplements use, were all found to be significantly more positive in users of dietary supplements compared to non-users (p<0.001). Results showed that attitudes, subjective norms and perceived behavioral control are important predictors in the intention to use dietary supplements for control of HIV among African-American women. Implications from this study suggest that the TPB can be used to better identify and understand salient beliefs that surround intentions to use alternative therapies for management of disease. These beliefs can be used to develop interventions surrounding HIV treatment and care. Copyright © 2014 Elsevier Ltd. All rights reserved.

Dietary supplement use is associated with higher intakes of minerals from food sources1234

PubMed Central

Fulgoni, Victor L; Keast, Debra R; Dwyer, Johanna T

2011-01-01

Background: Dietary supplement use is extensive in US adults. Some reports suggested that supplement users had higher nutrient intakes from the diet than did nonusers, but to our knowledge this finding has not been examined in nationally representative survey data. Objective: In this analysis, we examined mineral intakes from the diet by supplement-use categories and how these supplements contributed to meeting or exceeding Dietary Reference Intakes for selected minerals. Design: Data from adults (≥19 y of age; n = 8860) who participated in NHANES 2003–2006, a nationally representative, cross-sectional survey, were examined. Supplement use was defined as the participant's self-reported use of a supplement that contained one or more selected minerals. Results: Dietary intakes of minerals from food sources were higher for magnesium, copper, potassium, and selenium in male supplement users than in nonusers. For women, dietary intakes of minerals from food sources were higher for users than for nonusers for each mineral examined except for selenium. In women, users of calcium-containing dietary supplements were much more likely to meet the Estimated Average Requirement (EAR) than were nonusers. Even after consideration of supplement use, >14% of adults had inadequate intakes for calcium and magnesium on the basis of the percentage of adults with usual intakes less than the EAR. The prevalence of adults who exceeded the tolerable upper intake level (UL) for calcium, zinc, iron, and magnesium was higher in users than in nonusers. Conclusions: Individuals who used mineral-containing dietary supplements had higher mineral intakes from food sources in the diet than did nonusers. For all minerals examined, and particularly for calcium and magnesium in men and women and iron in women, supplement use decreased the prevalence of intake inadequacy for each respective mineral; however, supplements contributed to risk of potentially excessive intakes for calcium, iron, zinc, and magnesium. PMID:21955646

21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Code of Federal Regulations, 2011 CFR

2011-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.530 When must an investigation be conducted of your manufacturing processes and other batches? If the reason for a dietary supplement being returned implicates other batches, you must...

21 CFR 111.180 - Under this subpart G, what records must you make and keep?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2013 CFR

2013-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.180 - Under this subpart G, what records must you make and keep?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.530 When must an investigation be conducted of your manufacturing processes and other batches? If the reason for a dietary supplement being returned implicates other batches, you must...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2014 CFR

2014-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.180 - Under this subpart G, what records must you make and keep?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.530 When must an investigation be conducted of your manufacturing processes and other batches? If the reason for a dietary supplement being returned implicates other batches, you must...

21 CFR 111.560 - What requirements apply to the review and investigation of a product complaint?

Code of Federal Regulations, 2012 CFR

2012-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Product... a possible failure of a dietary supplement to meet any of its specifications, or any other... failure of a dietary supplement to meet any of its specifications, or any other requirements of this part...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.570 - Under this subpart O, what records must you make and keep?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Product Complaints § 111.570... name and description of the dietary supplement; (B) The batch, lot, or control number of the dietary supplement, if available; (C) The date the complaint was received and the name, address, or telephone number...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2012 CFR

2012-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2011 CFR

2011-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.180 - Under this subpart G, what records must you make and keep?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.570 - Under this subpart O, what records must you make and keep?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Product Complaints § 111.570... name and description of the dietary supplement; (B) The batch, lot, or control number of the dietary supplement, if available; (C) The date the complaint was received and the name, address, or telephone number...

21 CFR 111.560 - What requirements apply to the review and investigation of a product complaint?

Code of Federal Regulations, 2014 CFR

2014-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Product... a possible failure of a dietary supplement to meet any of its specifications, or any other... failure of a dietary supplement to meet any of its specifications, or any other requirements of this part...

21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Code of Federal Regulations, 2013 CFR

2013-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.530 When must an investigation be conducted of your manufacturing processes and other batches? If the reason for a dietary supplement being returned implicates other batches, you must...

76 FR 32215 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-03

... Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug... of information technology. Substantiation for Dietary Supplement Claims Made Under the Federal Food...) of the FD&C Act (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2010 CFR

2010-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

77 FR 57092 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-17

... to FDA's decision not to authorize four dietary supplement health claims that failed to meet the SSA... study is to collect quantitative data to examine consumer interpretations of two dietary supplement... Conventional Human Foods and Human Dietary Supplements,'' 2003, available at http://www.fda.gov/Food/Guidance...

21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

Code of Federal Regulations, 2010 CFR

2010-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.530 When must an investigation be conducted of your manufacturing processes and other batches? If the reason for a dietary supplement being returned implicates other batches, you must...

75 FR 42095 - Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-20

... Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug... Operations for Dietary Supplements--21 CFR 111.75(a)(1)(ii) (OMB Control Number 0910-0608)-- Extension On October 25, 1994, the Dietary Supplement Health and Education Act (DSHEA) (Public Law 103-417) was signed...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.180 - Under this subpart G, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

21 CFR 111.560 - What requirements apply to the review and investigation of a product complaint?

Code of Federal Regulations, 2010 CFR

2010-04-01

... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Product... a possible failure of a dietary supplement to meet any of its specifications, or any other... failure of a dietary supplement to meet any of its specifications, or any other requirements of this part...

Caffeine and Creatine Content of Dietary Supplements Consumed by Brazilian Soccer Players.

PubMed

Inácio, Suelen Galante; de Oliveira, Gustavo Vieira; Alvares, Thiago Silveira

2016-08-01

Caffeine and creatine are ingredients in the most popular dietary supplements consumed by soccer players. However, some products may not contain the disclosed amounts of the ingredients listed on the label, compromising the safe usage and the effectiveness of these supplements. Therefore, the aim of this study was to evaluate the content of caffeine and creatine in dietary supplements consumed by Brazilian soccer players. The results obtained were compared with the caffeine content listed on the product label. Two batches of the supplement brands consumed by ≥ 50% of the players were considered for analysis. The quantification of caffeine and creatine in the supplements was determined by a high-performance liquid chromatography system with UV detector. Nine supplements of caffeine and 7 supplements of creatine met the inclusion criteria for analysis. Eight brands of caffeine and five brands of creatine showed significantly different values (p < .05) as compared with the values stated on the label. There were no significant differences between the two batches of supplements analyzed, except for one caffeine supplement. It can be concluded that caffeine and creatine dietary supplements consumed by Brazilian soccer players present inaccurate values listed on the label, although most presented no difference among batches. To ensure consumer safety and product efficacy, accurate information on caffeine and creatine content should be provided on all dietary supplement labels.

Authentication of Ginkgo biloba herbal dietary supplements using DNA barcoding.

PubMed

Little, Damon P

2014-09-01

Ginkgo biloba L. (known as ginkgo or maidenhair tree) is a phylogenetically isolated, charismatic, gymnosperm tree. Herbal dietary supplements, prepared from G. biloba leaves, are consumed to boost cognitive capacity via improved blood perfusion and mitochondrial function. A novel DNA mini-barcode assay was designed and validated for the authentication of G. biloba in herbal dietary supplements (n = 22; sensitivity = 1.00, 95% CI = 0.59-1.00; specificity = 1.00, 95% CI = 0.64-1.00). This assay was further used to estimate the frequency of mislabeled ginkgo herbal dietary supplements on the market in the United States of America: DNA amenable to PCR could not be extracted from three (7.5%) of the 40 supplements sampled, 31 of 37 (83.8%) assayable supplements contained identifiable G. biloba DNA, and six supplements (16.2%) contained fillers without any detectable G. biloba DNA. It is hoped that this assay will be used by supplement manufacturers to ensure that their supplements contain G. biloba.

Total, dietary, and supplemental calcium intake and mortality from all-causes, cardiovascular disease, and cancer: A meta-analysis of observational studies.

PubMed

Asemi, Z; Saneei, P; Sabihi, S-S; Feizi, A; Esmaillzadeh, A

2015-07-01

This systematic review and meta-analysis of observational studies was conducted to summarize the evidence on the association between calcium intake and mortality. PubMed, Institute for Scientific Information (ISI) (Web of Science), SCOPUS, SciRUS, Google Scholar, and Excerpta Medica dataBASE (EMBASE) were searched to identify related articles published through May 2014. We found 22 articles that assessed the association between total, dietary, and supplementary intake with mortality from all-causes, cardiovascular disease (CVD), and cancer. Findings from this meta-analysis revealed no significant association between total and dietary calcium intake and mortality from all-causes, CVD, and cancer. Subgroup analysis by the duration of follow-up revealed a significant positive association between total calcium intake and CVD mortality for cohort studies with a mean follow-up duration of >10 years (relative risk (RR): 1.35; 95% confidence interval (CI): 1.09-1.68). A significant inverse association was seen between dietary calcium intake and all-cause (RR: 0.84; 95% CI: 0.70-1.00) and CVD mortality (RR: 0.88; 95% CI: 0.78-0.99) for studies with a mean follow-up duration of ≤10 years. Although supplemental calcium intake was not associated with CVD (RR: 0.95; 95% CI: 0.82-1.10) and cancer mortality (RR: 1.22; 95% CI: 0.81-1.84), it was inversely associated with the risk of all-cause mortality (RR: 0.91; 95% CI: 0.88-0.94). We found a significant relationship between the total calcium intake and an increased risk of CVD mortality for studies with a long follow-up time and a significant protective association between dietary calcium intake and all-cause and CVD mortality for studies with a mean follow-up of ≤10 years. Supplemental calcium intake was associated with a decreased risk of all-cause mortality. Copyright © 2015 Elsevier B.V. All rights reserved.

Transcriptome analysis of the Tan sheep testes: Differential expression of antioxidant enzyme-related genes and proteins in response to dietary vitamin E supplementation.

PubMed

Xu, Chenchen; Zuo, Zhaoyun; Liu, Kun; Jia, Huina; Zhang, Yuwei; Luo, Hailing

2016-03-15

Gene-chip technology was employed to study the effect of dietary vitamin E on gene expression in sheep testes based on our previous research. Thirty-five male Tan sheep (20-30 days after weaning) with similar body weight were randomly allocated into five groups and supplemented 0, 20, 100, 200 and 2,000 IU sheep(-1)day(-1) vitamin E (treatments denoted as E0, E20, E100, E200, and E2000, respectively) for 120 days. At the end of the study the sheep were slaughtered and the testis samples were immediately collected and stored in liquid nitrogen. Differences in gene expression between different treated groups were identified. Based on GO enrichment analysis and the KEGG database to evaluate the gene expression data we found that vitamin E might affect genes in the testes by modulating the oxidation level, by affecting the expression of various receptors and transcription factors in biological pathways, and by regulating the expression of metabolism-associated genes. The effect of vitamin E supplementation on the expression of oxidative enzyme-related genes was detected by quantitative real-time PCR (qRT-PCR) and Western blot. The results show that dietary vitamin E, at various doses, can significantly increase (P<0.05) the mRNA and protein expression of Glutathione peroxidase 3 and Glutathione S-transferase alpha 1. In addition, the results of qRT-PCR of the antioxidant enzyme genes were consistent with those obtained using the gene chip microarray analysis. In summary, the dietary vitamin E treatment altered the expression of a number of genes in sheep testes. The increase in the mRNA and protein levels of antioxidant enzyme genes, coupled with the elevation in the activity of the antioxidant enzymes were primarily responsible for the improved reproductive performance promoted by dietary vitamin E. Copyright © 2015 Elsevier B.V. All rights reserved.

Development of Dietary Polyphenol Preparations for Treating Veterans with Gulf War Illness

DTIC Science & Technology

2016-10-01

chronic fatigue. We hypothesized that dietary supplementation with a Flavonoid Rich Preparation (FRP), a combination of Concord Grape Juice (CGJ) and...We propose to test the feasibility of dietary supplementation with FRP in Veterans with GWI, and to gather evidence supporting the efficacy of FRP in...fatigue and preserve against cognitive functions. Based on this, our overall goal is to test the potential efficacy of dietary supplementation with a

Intestinal microbiota and immune related genes in sea cucumber (Apostichopus japonicus) response to dietary β-glucan supplementation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yang, Gang; Xu, Zhenjiang; Tian, Xiangli, E-mail: xianglitian@ouc.edu.cn

β-glucan is a prebiotic well known for its beneficial outcomes on sea cucumber health through modifying the host intestinal microbiota. High-throughput sequencing techniques provide an opportunity for the identification and characterization of microbes. In this study, we investigated the intestinal microbial community composition, interaction among species, and intestinal immune genes in sea cucumber fed with diet supplemented with or without β-glucan supplementation. The results show that the intestinal dominant classes in the control group are Flavobacteriia, Gammaproteobacteria, and Alphaproteobacteria, whereas Alphaproteobacteria, Flavobacteriia, and Verrucomicrobiae are enriched in the β-glucan group. Dietary β-glucan supplementation promoted the proliferation of the family Rhodobacteraceaemore » of the Alphaproteobacteria class and the family Verrucomicrobiaceae of the Verrucomicrobiae class and reduced the relative abundance of the family Flavobacteriaceae of Flavobacteria class. The ecological network analysis suggests that dietary β-glucan supplementation can alter the network interactions among different microbial functional groups by changing the microbial community composition and topological roles of the OTUs in the ecological network. Dietary β-glucan supplementation has a positive impact on immune responses of the intestine of sea cucumber by activating NF-κB signaling pathway, probably through modulating the balance of intestinal microbiota. - Highlights: • Dietary β-glucan supplementation increases the abundance of Rhodobacteraceae and Verrucomicrobiaceae in the intestine. • Dietary β-glucan supplementation changes the topological roles of OTUs in the ecological network. • Dietary β-glucan supplementation has a positive impact on the immune response of intestine of sea cucumber.« less

Dietary supplement use and mortality in a cohort of Swedish men.

PubMed

Messerer, Maria; Håkansson, Niclas; Wolk, Alicja; Akesson, Agneta

2008-03-01

The use of dietary supplements has increased substantially in most industrialized countries. The aim of this study was to prospectively examine the association between use of dietary supplements and all-cause mortality, cancer mortality and CVD mortality in men. We used the population-based prospective cohort of 38 994 men from central Sweden, 45-79 years of age, with no cancer or CVD at baseline and who completed a self-administered FFQ including questions on dietary supplement use and life-style factors in 1997. During average 7.7 years of follow-up, 3403 deaths were ascertained; among them, 771 due to cancer and 930 due to CVD (during 5.9 years of follow-up). In multivariate adjusted models including all men there was no association observed between use of any dietary supplement or of multivitamins, vitamin C, vitamin E or fish oil specifically and all-cause mortality, cancer or CVD mortality. Among current smokers, regular use of any supplement was associated with statistically significant increased risk of cancer mortality: relative risk (RR) 1.46 (95 % CI 1.06, 1.99). Among men reporting an inadequate diet at baseline (assessed by Recommended Food Score), there was a statistically significant inverse association between use of any dietary supplement and CVD mortality (RR 0.72; 95 % CI 0.57, 0.91), no associations were observed among men with adequate diets. In conclusion, we cannot exclude that the use of dietary supplements is harmful for smokers. On the other hand, among men with an insufficient diet, the use of supplements might be beneficial in reducing CVD mortality.

Dietary Supplementations as Neuroprotective Therapies: Focus on NT-020 Diet Benefits in a Rat Model of Stroke

PubMed Central

Kaneko, Yuji; Cortes, Lourdes; Sanberg, Cyndy; Acosta, Sandra; Bickford, Paula C.; Borlongan, Cesar V.

2012-01-01

Stroke remains the number one cause of disability in the adult population. Despite scientific progress in our understanding of stroke pathology, only one treatment (tissue plasminogen activator or tPA) is able to afford benefits but to less than 3% of ischemic stroke patients. The development of experimental dietary supplement therapeutics designed to stimulate endogenous mechanisms that confer neuroprotection is likely to open new avenues for exploring stroke therapies. The present review article evaluates the recent literature supporting the benefits of dietary supplementation for the therapy of ischemic stroke. This article focuses on discussing the medical benefits of NT-020 as an adjunct agent for stroke therapy. Based on our preliminary data, a pre-stroke treatment with dietary supplementation promotes neuroprotection by decreasing inflammation and enhancing neurogenesis. However, we recognize that a pre-stroke treatment holds weak clinical relevance. Thus, the main goal of this article is to provide information about recent data that support the assumption of natural compounds as neuroprotective and to evaluate the therapeutic effects of a dietary supplement called NT-020 as in a stroke model. We focus on a systematic assessment of practical treatment parameters so that NT-020 and other dietary supplementations can be developed as an adjunct agent for the prevention or treatment of chronic diseases. We offer rationale for determining the optimal dosage, therapeutic window, and mechanism of action of NT-020 as a dietary supplement to produce neuroprotection when administered immediately after stroke onset. We highlight our long-standing principle in championing both translational and basic science approaches in an effort to fully reveal the therapeutic potential of NT-020 as dietary supplementation in the treatment of stroke. We envision dietary supplementation as an adjunct therapy for stroke at acute, subacute, and even chronic periods. PMID:22837703

Dietary α-ketoglutarate supplementation improves hepatic and intestinal energy status and anti-oxidative capacity of Cherry Valley ducks.

PubMed

Guo, Shuangshuang; Duan, Rui; Wang, Lei; Hou, Yongqing; Tan, Linglin; Cheng, Qiang; Liao, Man; Ding, Binying

2017-11-01

α-Ketoglutarate (AKG) is an extensively used dietary supplement in human and animal nutrition. The aim of the present study was to investigate effects of dietary AKG supplementation on the energy status and anti-oxidative capacity in liver and intestinal mucosa of Cherry Valley ducks. A total of 80 1-day-old ducks were randomly assigned into four groups, in which ducks were fed basal diets supplemented with 0% (control), 0.5%, 1.0% and 1.5% AKG, respectively. Graded doses of AKG supplementation linearly decreased the ratio of adenosine monophosphate (AMP) to adenosine triphosphate (ATP) in the liver, but increased ATP content and adenylate energy charge (AEC) in a quadratic and linear manner, respectively (P < 0.05). Increasing dietary AKG supplemental levels produced linear positive responses in ATP content and AEC, and negative responses in AMP concentration, the ratio of AMP to ATP and total adenine nucleotide in the ileal mucosa (P < 0.05). All levels of dietary AKG reduced the production of jejunal hydrogen peroxide and hepatic malondialdehyde (P < 0.05). Hepatic and ileal messenger RNA expression of AMP kinase α-1 and hypoxia-inducible factor-1α were linearly up-regulated as dietary AKG supplemental levels increased (P < 0.05). In conclusion, dietary AKG supplementation linearly or quadratically enhanced hepatic and intestinal energy storage and anti-oxidative capacity of Cherry Valley ducks. © 2017 Japanese Society of Animal Science.

Effects of dietary protein levels and 2-methylbutyrate on ruminal fermentation, nutrient degradability, bacterial populations and urinary purine derivatives in Simmental steers.

PubMed

Wang, C; Liu, Q; Guo, G; Huo, W J; Pei, C X; Zhang, S L; Yang, W Z

2018-06-01

The objective of this study was to evaluate the effects of dietary crude protein (CP) levels and 2-methylbutyrate (MB) supplementation on ruminal fermentation, bacterial populations, microbial enzyme activity and urinary excretion of purine derivatives (PD) in Simmental steers. Eight ruminally cannulated Simmental steers, averaging 18 months of age and 465 ± 8.6 kg of body weight (BW), were used in a replicated 4 × 4 Latin square design by a 2 × 2 factorial arrangement. Low protein (98.5 g CP/kg dry matter [LP] or high protein (128.7 g CP/kg dry matter [HP]) diets were fed with MB supplementation (0 g [MB-] or 16.8 g steer -1  day -1 [MB+]). Steers were fed a total mixed ration with dietary corn straw to concentrate ratio of 50:50 (dry matter [DM] basis). The CP × MB interaction was observed for ruminal total VFA, molar proportions of acetate and propionate, acetate to propionate ratio, ammonia-N, effective degradability of neutral detergent fibre (NDF) and CP, microbial enzyme activity, bacterial populations and total PD excretion (p < .05). Ruminal pH decreased (p < .05), but ruminal total VFA concentration increased (p < .05) with increasing dietary CP level or MB supplementation. Acetate molar proportion increased (p = .043) with MB supplementation, but was not affected by dietary CP level. Propionate molar proportion decreased (p < .05) with increasing dietary CP level or MB supplementation. Consequently, acetate-to-propionate ratio increased (p = .001) with MB supplementation, but was not affected by dietary CP level. Ruminal ammonia-N content increased (p = .034) with increasing dietary CP level, but decreased (p = .012) with MB supplementation. The effective degradability of NDF and CP increased (p < .05) with increasing dietary CP level or MB supplementation. Microbial enzyme activity, bacterial populations and total PD excretion also increased (p < .05) with increasing dietary CP level or MB supplementation. The results indicated that ruminal fermentation, nutrient degradability, microbial enzyme activity, ruminal bacterial populations and microbial protein synthesis improved with increasing dietary CP level or MB supplementation in steers. © 2017 Blackwell Verlag GmbH.

Data-Driven Identification of Structural Alerts for Mitigating the Risk of Drug-Induced Human Liver Injuries

DTIC Science & Technology

2015-02-11

the National Library of Medicine of the U.S. National Institutes of Health launched LiverTox, a data- base of ~700 medications associated with human... herbal remedies, and dietary supplements. Carefully curated and reviewed by experts in multiple disciplines, the database constitutes a valu- able resource...March 2014 via web access at http://livertox.nih.gov/. We then removed entries without chemical structures, such as some herbal extracts and vac

Quantitative Determination of Vinpocetine in Dietary Supplements.

PubMed

French, John M T; King, Matthew D; McDougal, Owen M

2016-05-01

Current United States regulatory policies allow for the addition of pharmacologically active substances in dietary supplements if derived from a botanical source. The inclusion of certain nootropic drugs, such as vinpocetine, in dietary supplements has recently come under scrutiny due to the lack of defined dosage parameters and yet unproven short- and long-term benefits and risks to human health. This study quantified the concentration of vinpocetine in several commercially available dietary supplements and found that a highly variable range of 0.6-5.1 mg/serving was present across the tested products, with most products providing no specification of vinpocetine concentrations.

A Pilot Study of Website Information Regarding Aromatase Inhibitors: Dietary Supplement Interactions

PubMed Central

McDermott, Cara L.; Hsieh, Angela A.; Sweet, Erin S.; Tippens, Kimberly M.

2011-01-01

Abstract Objectives Patients who have hormone receptor–positive breast cancer and who are taking aromatase inhibitors (AIs) should understand the benefits and risks of concomitant dietary supplement (DS) use. The International Society for Integrative Oncology (SIO) encourages patients to discuss DS use with their health care practitioners. The objective was to conduct a pilot study rating Internet websites from the perspective of health care practitioners for information about AI–DS interactions. Design Five (5) Internet websites suggested by SIO were evaluated using the DISCERN instrument rating tool. The available AI–DS information on these websites was rated by 4 evaluators: 2 naturopathic doctors, 1 oncology pharmacy resident, and a pharmacy student. Results The overall rankings ranged from 1.6 to 3.9, with considerable variability in the type of information available from the websites. The interevaluator rankings of the websites ranged from 0.44 to 0.89. The evaluators consistently found the most reliable, unbiased, and comprehensive information on AI–DS interactions at the Natural Medicines Comprehensive Database and Memorial Sloan-Kettering Cancer Center websites. However, more than one database was needed for provision of optimal patient information on AI–DS interactions. Conclusions In order to effectively advise patients regarding AI–DS interactions, more than one website should be evaluated to assess the potential efficacy and safety of DS in women whose breast cancer is being treated with an AI. PMID:22087614

Dietary Supplementation in Children with Autism Spectrum Disorders: Common, Insufficient, and Excessive.

PubMed

Stewart, Patricia A; Hyman, Susan L; Schmidt, Brianne L; Macklin, Eric A; Reynolds, Ann; Johnson, Cynthia R; James, S Jill; Manning-Courtney, Patricia

2015-08-01

Little is known about the effect on dietary adequacy of supplements given to children with autism spectrum disorder (ASD). This cross-sectional study examines dietary supplement use and micronutrient intake in children with ASD. Three-day diet/supplement records and use of a gluten/casein-free diet (GFCF) were documented. Estimates of usual intake of micronutrients from food and supplements were compared with the Dietary Reference Intakes. Children aged 2 to 11 years (N=288) with ASD from five Autism Treatment Network sites from 2009-2011. Percentage of children meeting or exceeding upper limits of micronutrient intake with or without supplements and relative to GFCF diet status. Micronutrient intake from food and supplements was compared by Spearman rank correlation. Usual intake was estimated by the National Cancer Institute method adjusted for age, sex, supplement use, and GFCF diet. Adequacy of intake was compared between supplement use status and between food and total intake in supplement users relative to Dietary Reference Intakes limits. Dietary supplements, especially multivitamin/minerals, were used by 56% of children with ASD. The most common micronutrient deficits were not corrected (vitamin D, calcium, potassium, pantothenic acid, and choline) by supplements. Almost one-third of children remained deficient for vitamin D and up to 54% for calcium. Children receiving GFCF diets had similar micronutrient intake but were more likely to use supplements (78% vs 56%; P=0.01). Supplementation led to excess vitamin A, folate, and zinc intake across the sample, vitamin C, and copper among children aged 2 to 3 years, and manganese and copper for children aged 4 to 8 years. Few children with ASD need most of the micronutrients they are commonly given as supplements, which often leads to excess intake. Even when supplements are used, careful attention should be given to adequacy of vitamin D and calcium intake. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

National Athletic Trainers' Association Position Statement: Evaluation of Dietary Supplements for Performance Nutrition

PubMed Central

Buell, Jackie L; Franks, Rob; Ransone, Jack; Powers, Michael E; Laquale, Kathleen M; Carlson-Phillips, Amanda

2013-01-01

Objectives To help athletic trainers promote a “food-first” philosophy to support health and performance, understand federal and sport governing body rules and regulations regarding dietary supplements and banned substances, and become familiar with reliable resources for evaluating the safety, purity, and efficacy of dietary supplements. Background The dietary supplement industry is poorly regulated and takes in billions of dollars per year. Uneducated athletes need to gain a better understanding of the safety, eligibility, and efficacy concerns associated with choosing to take dietary supplements. The athletic trainer is a valuable athletic team member who can help in the educational process. In many cases, athletic trainers are asked to help evaluate the legality, safety, and efficacy of dietary supplements. For this position statement, our mission is to provide the athletic trainer with the necessary resources for these tasks. Recommendations Proper nutrition and changes in the athlete's habitual diet should be considered first when improved performance is the goal. Athletes need to understand the level of regulation (or lack thereof) governing the dietary supplement industry at the international, federal, state, and individual sport-participation levels. Athletes should not assume a product is safe simply because it is marketed over the counter. All products athletes are considering using should be evaluated for purity (ie, truth in labeling), safety, and efficacy. PMID:23672334

Which sources of flavonoids: complex diets or dietary supplements?

PubMed

Egert, Sarah; Rimbach, Gerald

2011-01-01

There is increasing interest in the potential health benefits of dietary flavonoids. Fruits and vegetables, tea, and cocoa are rich natural sources of flavonoids. Epidemiological studies have indicated that consumption of these foods is likely to be associated with a reduced risk of cardiovascular disease, but the etiology of this benefit is not yet clearly defined. Furthermore, in some acute interventions, a positive effect of tea and cocoa on vascular function has been reported. An alternative source of flavonoids is dietary supplements, which have become increasingly popular in the recent past. In this context, it needs to be critically evaluated whether vascular health-promoting and other positive properties of flavonoid-rich diets can be replaced by purified flavonoids as dietary supplements. Plant sources of flavonoids contain a complex mixture of secondary plant metabolites and not only flavonoids per se. This complex mixture of secondary plant metabolites cannot be simply exchanged by single purified compounds as dietary supplements. If flavonoids are given as dietary supplements, toxicity issues as well as nutrient drug interactions need to be taken into account. Purified flavonoids given in high doses as dietary supplements may affect trace element, folate, and vitamin C status. Furthermore, they may exhibit antithyroid and goitrogenic activities. In this review article, the available literature on the safety issues surrounding high dose supplemental flavonoid consumption has been summarized.

Which Sources of Flavonoids: Complex Diets or Dietary Supplements?1

PubMed Central

Egert, Sarah; Rimbach, Gerald

2011-01-01

There is increasing interest in the potential health benefits of dietary flavonoids. Fruits and vegetables, tea, and cocoa are rich natural sources of flavonoids. Epidemiological studies have indicated that consumption of these foods is likely to be associated with a reduced risk of cardiovascular disease, but the etiology of this benefit is not yet clearly defined. Furthermore, in some acute interventions, a positive effect of tea and cocoa on vascular function has been reported. An alternative source of flavonoids is dietary supplements, which have become increasingly popular in the recent past. In this context, it needs to be critically evaluated whether vascular health-promoting and other positive properties of flavonoid-rich diets can be replaced by purified flavonoids as dietary supplements. Plant sources of flavonoids contain a complex mixture of secondary plant metabolites and not only flavonoids per se. This complex mixture of secondary plant metabolites cannot be simply exchanged by single purified compounds as dietary supplements. If flavonoids are given as dietary supplements, toxicity issues as well as nutrient drug interactions need to be taken into account. Purified flavonoids given in high doses as dietary supplements may affect trace element, folate, and vitamin C status. Furthermore, they may exhibit antithyroid and goitrogenic activities. In this review article, the available literature on the safety issues surrounding high dose supplemental flavonoid consumption has been summarized. PMID:22211185

Dietary supplements for football.

PubMed

Hespel, P; Maughan, R J; Greenhaff, P L

2006-07-01

Physical training and competition in football markedly increase the need for macro- and micronutrient intake. This requirement can generally be met by dietary management without the need for dietary supplements. In fact, the efficacy of most supplements available on the market is unproven. In addition, players must be cautious of inadequate product labelling and supplement impurities that may cause a positive drug test. Nonetheless, a number of dietary supplements may beneficially affect football performance. A high endurance capacity is a prerequisite for optimal match performance, particularly if extra time is played. In this context, the potential of low-dose caffeine ingestion (2 - 5 mg . kg body mass(-1)) to enhance endurance performance is well established. However, in the case of football, care must be taken not to overdose because visual information processing might be impaired. Scoring and preventing goals as a rule requires production of high power output. Dietary creatine supplementation (loading dose: 15 - 20 g . day(-1), 4 - 5 days; maintenance dose: 2 - 5 g g . day(-1)) has been found to increase muscle power output, especially during intermittent sprint exercises. Furthermore, creatine intake can augment muscle adaptations to resistance training. Team success and performance also depend on player availability, and thus injury prevention and health maintenance. Glucosamine or chondroitin may be useful in the treatment of joint pain and osteoarthritis, but there is no evidence to support the view that the administration of these supplements will be preventative. Ephedra-containing weight-loss cocktails should certainly be avoided due to reported adverse health effects and positive doping outcomes. Finally, the efficacy of antioxidant or vitamin C intake in excess of the normal recommended dietary dose is equivocal. Responses to dietary supplements can vary substantially between individuals, and therefore the ingestion of any supplement must be assessed in training before being used in competition. It is recommended that dietary supplements are only used based on the advice of a qualified sports nutrition professional.

78 FR 20672 - Literature Review Approach “Identifying Research Needs for Assessing Safe Use of High Intakes of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Sciences (NIEHS) in conjunction with the NIH Office of Dietary Supplements (ODS) is planning a workshop to... is folic acid, the form of folate commonly added to foods and dietary supplements. Information... hazards to human health from exposure to environmental substances, including dietary supplements (see http...

76 FR 55919 - Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...; dietary supplements and other special nutritional products (e.g., infant formula and medical foods); and... regulates the safety (i.e., adulteration) of dietary supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary supplements do not require premarket approval by FDA and the Agency bears the burden to...

Consumption of Sport-Related Dietary Supplements among NCAA Division 1 Female Student Athletes

ERIC Educational Resources Information Center

Housman, Jeff; Dorman, Steve; Pruitt, Buzz; Ranjita, Misra; Perko, Michael

2011-01-01

Objectives: To determine factors that influence sport-related dietary supplement consumption among NCAA Division 1 female student athletes and to estimate the plausibility of the theory of planned behavior (TPB) for predicting the use of sport-related dietary supplements among NCAA Division 1 female student athletes. Method: Self-report data were…

21 CFR 111.90 - What requirements apply to treatments, in-process adjustments, and reprocessing when there is a...

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless: (1) Quality control...

Inorganic elemental compositions of commercial multivitamin/mineral dietary supplements: application of collision/reaction cell inductively coupled-mass spectroscopy

USDA-ARS?s Scientific Manuscript database

Microwave digestion followed by analysis using ICP-MS has been shown to be a simple, fast reliable method for the multi-element determination in multivitamin/mineral dietary supplements (MVM). A study of 35 popular MVM dietary supplements revealed that composition and levels varied among products, a...

Dietary supplement usage and motivation in Brazilian road runners.

PubMed

Salgado, José Vítor Vieira; Lollo, Pablo Christiano Barboza; Amaya-Farfan, Jaime; Chacon-Mikahil, Mara PatríciaTraina

2014-01-01

The consumption of dietary supplements is highest among athletes and it can represent potential a health risk for consumers. The aim of this study was to determine the prevalence of consumption of dietary supplements by road runners. We interviewed 817 volunteers from four road races in the Brazilian running calendar. The sample consisted of 671 male and 146 female runners with a mean age of 37.9 ± 12.4 years. Of the sample, 28.33% reported having used some type of dietary supplement. The main motivation for this consumption is to increase in stamina and improve performance. The probability of consuming dietary supplements increased 4.67 times when the runners were guided by coaches. The consumption of supplements was strongly correlated (r = 0.97) with weekly running distance, and also highly correlated (r = 0.86) with the number of years the sport had been practiced. The longer the runner had practiced the sport, the higher the training volume and the greater the intake of supplements. The five most frequently cited reasons for consumption were: energy enhancement (29.5%), performance improvement (17.1%), increased level of endurance (10.3%), nutrient replacement (11.1%), and avoidance of fatigue (10.3%). About 30% of the consumers declared more than one reason for taking dietary supplements. The most consumed supplements were: carbohydrates (52.17%), vitamins (28.70%), and proteins (13.48%). Supplement consumption by road runners in Brazil appeared to be guided by the energy boosting properties of the supplement, the influence of coaches, and the experience of the user. The amount of supplement intake seemed to be lower among road runners than for athletes of other sports. We recommend that coaches and nutritionists emphasise that a balanced diet can meet the needs of physically active people.

Prevalence and predictors of children's dietary supplement use: the 2007 National Health Interview Survey1234

PubMed Central

Dwyer, Johanna; Nahin, Richard L; Rogers, Gail T; Barnes, Patricia M; Jacques, Paul M; Sempos, Christopher T; Bailey, Regan

2013-01-01

Background: Little is known about the characteristics of US children who are dietary supplement users. Objective: We described the prevalence and predictors of and reasons for giving children dietary supplements. Design: The study included children <18 y of age who participated in the Complementary and Alternative Medicine supplement of the National Health Interview Survey of 2007 whose proxies provided complete information on child dietary supplement use. Results: A total of 37% of subjects used dietary supplements, 31% of subjects used multivitamin mineral (MVM) products exclusively, 4% of subjects used single vitamins or minerals solely or in combination with MVMs, and 2% of subjects used nonvitamin, nonmineral products either solely or in combination with other supplements. Users were more likely than nonusers to be Asian, white, or non-Hispanic; belong to families with higher parental education and income levels; reside in areas other than the South; be in good, very good, or excellent health; have private health insurance; and have a usual place at which they received conventional medical care. Children (3%) with the most disease burden and health care were more likely to use supplements than were healthier children. Supplements were given for the prevention or treatment of many illnesses and conditions. Neither the caregiver's reasons nor specific supplements used were consistently associated with particular conditions. Conclusions: The 37% of US children who used any type of dietary supplements differed from nonusers in family socioeconomic status and many other health-related characteristics. Users were given supplements to prevent or treat many illnesses and conditions for which there is only limited evidence of their efficacy. PMID:23576049

Dietary supplement use among infants, children, and adolescents in the United States, 1999-2002.

PubMed

Picciano, Mary Frances; Dwyer, Johanna T; Radimer, Kathy L; Wilson, David H; Fisher, Kenneth D; Thomas, Paul R; Yetley, Elizabeth A; Moshfegh, Alanna J; Levy, Paul S; Nielsen, Samara Joy; Marriott, Bernadette M

2007-10-01

To describe dietary supplement use among US children. Analysis of nationally representative data from the 1999-2002 National Health and Nutrition Examination Survey (NHANES). Home interviews and a mobile examination center. Children from birth through 18 years who participated in NHANES (N=10,136). Frequency of use of any dietary supplement product. Prevalence of use and intake of key nutrients from supplements among children. In 1999-2002, 31.8% of children used dietary supplements, with the lowest use reported among infants younger than 1 year (11.9%) and teenagers 14 to 18 years old (25.7%) and highest use among 4- to 8-year-old children (48.5%). Use was highest among non-Hispanic white (38.1%) and Mexican American (22.4%) participants, lowest among non-Hispanic black participants (18.8%), and was not found to differ by sex. The type of supplement most commonly used was multivitamins and multiminerals (18.3%). Ascorbic acid (28.6%), retinol (25.8%), vitamin D (25.6%), calcium (21.1%), and iron (19.3%) were the primary supplemental nutrients consumed. Supplement use was associated with families with higher incomes; a smoke-free environment; not being certified by the US Department of Agriculture Special Supplemental Nutrition Program for Women, Infants and Children in the last 12 months; lower child body mass index; and less daily recreational screen time (television, video games, computers, etc) (P<.005). The highest prevalence of supplement use (P<.005) was in children who were underweight or at risk for underweight (P<.005). More than 30% of children in the United States take dietary supplements regularly, most often multivitamins and multiminerals. Given such extensive use, nutrient intakes from dietary supplements must be included to obtain accurate estimates of overall nutrient intake in children.

The use of dietary supplement among soldiers from the macedonian special operations regiment.

PubMed

Kjertakov, Metodija; Hristovski, Robert; Racaj, Muhamet

2013-01-01

To determine the prevalence and type of dietary supplement used, reasons for use, and sources of supplement information among Macedonian elite Soldiers. Anonymous self-reported questionnaires containing questions about demographic characteristics and dietary supplementation practices were distributed to 134 Soldiers, of whom 80 were recruited from the Ranger Battalion (R) and 54 from the Special Force Battalion (SF). The Soldiers completed and returned 132 questionnaires. Overall, 66.6% of the Soldiers, including 70.3% of SF and 64.1% of R, reported using supplements within the 3 months before the survey. On average, each of these Soldiers used 3.7 ? 2.9 supplements. The most commonly used supplements were multivitamins (50.0%) and vitamin C (47.7%). The most frequently cited reason for using supplements was to improve general health (51.6%). Primary sources of supplement information were friends (42.0%) and books/magazines (40.9%). Dietary supplement use was found to be common and widespread among this military subpopulation. Given this, and the fact that the majority of the Soldiers do not receive accurate information about supplements, educational intervention regarding the safety and efficacy of these products is needed if unnecessary or harmful supplementation practices are to be prevented. 2013.

AOAC SMPR 2014.007: Authentication of selected Vaccinium species (Anthocyanins) in dietary ingredients and dietary supplements

USDA-ARS?s Scientific Manuscript database

This AOAC Standard Method Performance Requirements (SMPR) is for authentication of selected Vaccinium species in dietary ingredients and dietary supplements containing a single Vaccinium species using anthocyanin profiles. SMPRs describe the minimum recommended performance characteristics to be used...

Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

PubMed

Gibson, James E; Taylor, David A

2005-09-01

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

Identification and Quantification of Gingerols and Related Compounds in Ginger Dietary Supplements Using High Performance Liquid Chromatography-Tandem Mass Spectrometry

PubMed Central

TAO, YI; LI, WENKUI; LIANG, WENZHONG; VAN BREEMEN, RICHARD B.

2009-01-01

Dietary supplements containing preparations of ginger roots/rhizomes (Zingiber officinale Roscoe) are being used by consumers, and clinical trials using ginger dietary supplements have been carried out to evaluate their anti-inflammatory or anti-emetic properties with inconsistent results. Chemical standardization of these products is needed for quality control and to facilitate the design of clinical trials and the evaluation of data from these studies. To address this issue, methods based on liquid chromatography-tandem mass spectrometry (LC-MS-MS) were developed for the detection, characterization and quantitative analysis of gingerol-related compounds in botanical dietary supplements containing ginger roots/rhizomes. During negative ion electrospray with collision induced-dissociation, the cleavage of the C4-C5 bond with a neutral loss of 194 u and benzylic cleavage leading to the neutral loss of 136 u were found to be class characteristic fragmentation patterns of the pharmacologically active gingerols or shogaols, respectively. Based on these results, an assay using LC-MS-MS with neutral loss scanning (loss of 194 u or 136 u) was developed that is suitable for the fingerprinting of ginger dietary supplements based on the selective detection of gingerols, shogaols, paradols, and gingerdiones. In addition, a quantitative assay based on LC-MS-MS with selected reaction monitoring was developed for the quantitative analysis of 6-gingerol, 8-gingerol, 10-gingerol, 6-shogaol, 8-shogaol, and 10-shogaol in ginger dietary supplements. After method validation, the quantities of these compounds in three commercially available ginger dietary supplements were determined. This assay showed excellent sensitivity, accuracy and precision and may be used to address the need for quality control and standardization of ginger dietary supplements. PMID:19817455

Pregnant Canadian Women Achieve Recommended Intakes of One-Carbon Nutrients through Prenatal Supplementation but the Supplement Composition, Including Choline, Requires Reconsideration.

PubMed

Masih, Shannon P; Plumptre, Lesley; Ly, Anna; Berger, Howard; Lausman, Andrea Y; Croxford, Ruth; Kim, Young-In; O'Connor, Deborah L

2015-08-01

Folate, vitamin B-6, vitamin B-12, and choline are involved in one-carbon metabolism and play critical roles in pregnancy including prevention of birth defects and promotion of neurodevelopment. However, excessive intakes may adversely affect disease susceptibility in offspring. Intakes of these nutrients during pregnancy are not well characterized. Our aim was to determine dietary and supplemental intakes and major dietary sources of one-carbon nutrients during pregnancy. In pregnant women (n = 368) at ≤16 wk postconception, supplement use >30 d before pregnancy was assessed by maternal recall and supplement and dietary intakes in early (0-16 wk) and late pregnancy (23-37 wk) were assessed by food-frequency questionnaire. Preconception, 60.1% (95% CI: 55.8, 64.3) of women used B vitamin-containing supplements. This increased to 92.8% (95% CI: 89.6, 95.2) in early and 89.0% (95% CI: 85.0, 92.3) in late pregnancy. Median supplemental folic acid, vitamin B-12, and vitamin B-6 were 1000 μg/d, 2.6 μg/d, and 1.9 mg/d, respectively. Forty-one percent and 50% of women had dietary intakes of folate and vitamin B-6 less than the estimated average requirement (520 mg/d dietary folate equivalents and 1.6 mg/d, respectively). Eight-seven percent of women had choline intakes less than the Adequate Intake (450 mg/d). Dietary intakes did not change appreciably during pregnancy. Fruits and vegetables and fortified foods contributed ∼57% to total dietary folate intake. Fruits and vegetables contributed ∼32% to total dietary vitamin B-6 intake and dairy and egg products contributed ∼37% to total dietary vitamin B-12 intake. Vitamin supplements were an important source of one-carbon nutrients during pregnancy in our sample. Without supplements, many women would not have consumed quantities of folate and vitamin B-6 consistent with recommendations. Given the importance of choline in pregnancy, further research to consider inclusion in prenatal supplements is warranted. This trial was registered at clinicaltrials.gov as NCT02244684. © 2015 American Society for Nutrition.

Leveraging corporate social responsibility to improve consumer safety of dietary supplements sold for weight loss and muscle building.

PubMed

Kulkarni, Anvita; Huerto, Ryan; Roberto, Christina A; Austin, S Bryn

2017-03-01

The potential dangers associated with dietary supplements sold for weight loss and muscle building are well documented and increasingly garnering the attention of the media, public, and government leaders. Public health professionals have an opportunity to improve population health in the context of dietary supplement use by translating scientific evidence into action. In this commentary, we discuss the potential to motivate corporate social responsibility (CSR) among manufacturers and retailers of dietary supplements sold for weight loss and muscle building. We examine levers available to public health professionals for generating voluntary corporate self-regulation by reviewing examples from successful CSR initiatives in other domains of public health and offering recommendations highlighting effective advocacy strategies. We encourage public health professionals to use one or multiple advocacy strategies to improve consumer protections for dietary supplements sold for weight loss and muscle building.

Development of Safe and Effective Botanical Dietary Supplements

PubMed Central

2015-01-01

Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082

The Dangerous Mix of Adolescents and Dietary Supplements for Weight Loss and Muscle Building: Legal Strategies for State Action.

PubMed

Pomeranz, Jennifer L; Barbosa, Grant; Killian, Caroline; Austin, S Bryn

2015-01-01

Adolescents use dietary supplements marketed for weight loss or muscle building, but these are not recommended by physicians. These products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans' use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.

Chromatographic fingerprint analysis of yohimbe bark and related dietary supplements using UHPLC/UV/MS.

PubMed

Sun, Jianghao; Chen, Pei

2012-03-05

A practical ultra high-performance liquid chromatography (UHPLC) method was developed for fingerprint analysis of and determination of yohimbine in yohimbe barks and related dietary supplements. Good separation was achieved using a Waters Acquity BEH C(18) column with gradient elution using 0.1% (v/v) aqueous ammonium hydroxide and 0.1% ammonium hydroxide in methanol as the mobile phases. The study is the first reported chromatographic method that separates corynanthine from yohimbine in yohimbe bark extract. The chromatographic fingerprint analysis was applied to the analysis of 18 yohimbe commercial dietary supplement samples. Quantitation of yohimbine, the traditional method for analysis of yohimbe barks, were also performed to evaluate the results of the fingerprint analysis. Wide variability was observed in fingerprints and yohimbine content among yohimbe dietary supplement samples. For most of the dietary supplements, the yohimbine content was not consistent with the label claims. Copyright © 2011. Published by Elsevier B.V.

Herbal Products and Supplements

MedlinePlus

... called a botanical product) is a type of dietary supplement that contains one or more herbs. Herbal health ... effective by the FDA. But the FDA defines dietary supplements as a category of food, not as drugs. ...

Herbs, Supplements and Alternative Medicines

MedlinePlus

... manage diabetes. Still, more and more people use dietary supplements. And studies show that people with diabetes are ... while another study found that 31 percent used dietary supplements . Certain ethnic groups, such as Hispanics, Native Americans, ...

Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms

PubMed Central

Jacobs, Elizabeth T.; Baron, John A.; Marshall, James R.; Byers, Tim

2012-01-01

Nutritional supplementation is now a multibillion-dollar industry, and about half of all US adults take supplements. Supplement use is fueled in part by the belief that nutritional supplements can ward off chronic disease, including cancer, although several expert committees and organizations have concluded that there is little to no scientific evidence that supplements reduce cancer risk. To the contrary, there is now evidence that high doses of some supplements increase cancer risk. Despite this evidence, marketing claims by the supplement industry continue to imply anticancer benefits. Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk. PMID:22534785

Multiple dietary supplements do not affect metabolic and cardiovascular health

PubMed Central

Holloszy, John O.; Fontana, Luigi

2014-01-01

Dietary supplements are widely used for health purposes. However, little is known about the metabolic and cardiovascular effects of combinations of popular over-the-counter supplements, each of which has been shown to have anti-oxidant, anti-inflammatory and pro-longevity properties in cell culture or animal studies. This study was a 6-month randomized, single-blind controlled trial, in which 56 non-obese (BMI 21.0-29.9 kg/m2) men and women, aged 38 to 55 yr, were assigned to a dietary supplement (SUP) group or control (CON) group, with a 6-month follow-up. The SUP group took 10 dietary supplements each day (100 mg of resveratrol, a complex of 800 mg each of green, black, and white tea extract, 250 mg of pomegranate extract, 650 mg of quercetin, 500 mg of acetyl-l-carnitine, 600 mg of lipoic acid, 900 mg of curcumin, 1 g of sesamin, 1.7 g of cinnamon bark extract, and 1.0 g fish oil). Both the SUP and CON groups took a daily multivitamin/mineral supplement. The main outcome measures were arterial stiffness, endothelial function, biomarkers of inflammation and oxidative stress, and cardiometabolic risk factors. Twenty-four weeks of daily supplementation with 10 dietary supplements did not affect arterial stiffness or endothelial function in nonobese individuals. These compounds also did not alter body fat measured by DEXA, blood pressure, plasma lipids, glucose, insulin, IGF-1, and markers of inflammation and oxidative stress. In summary, supplementation with a combination of popular dietary supplements has no cardiovascular or metabolic effects in non-obese relatively healthy individuals. PMID:24659610

Dietary supplementation with monosodium glutamate is safe and improves growth performance in postweaning pigs.

PubMed

Rezaei, Reza; Knabe, Darrell A; Tekwe, Carmen D; Dahanayaka, Sudath; Ficken, Martin D; Fielder, Susan E; Eide, Sarah J; Lovering, Sandra L; Wu, Guoyao

2013-03-01

Dietary intake of glutamate by postweaning pigs is markedly reduced due to low feed consumption. This study was conducted to determine the safety and efficacy of dietary supplementation with monosodium glutamate (MSG) in postweaning pigs. Piglets were weaned at 21 days of age to a corn and soybean meal-based diet supplemented with 0, 0.5, 1, 2, and 4 % MSG (n = 25/group). MSG was added to the basal diet at the expense of cornstarch. At 42 days of age (21 days after weaning), blood samples (10 mL) were obtained from the jugular vein of 25 pigs/group at 1 and 4 h after feeding for hematological and clinical chemistry tests; thereafter, pigs (n = 6/group) were euthanized to obtain tissues for histopathological examinations. Feed intake was not affected by dietary supplementation with 0-2 % MSG and was 15 % lower in pigs supplemented with 4 % MSG compared with the 0 % MSG group. Compared with the control, dietary supplementation with 1, 2 and 4 % MSG dose-dependently increased plasma concentrations of glutamate, glutamine, and other amino acids (including lysine, methionine, phenylalanine and leucine), daily weight gain, and feed efficiency in postweaning pigs. At day 7 postweaning, dietary supplementation with 1-4 % MSG also increased jejunal villus height, DNA content, and antioxidative capacity. The MSG supplementation dose-dependently reduced the incidence of diarrhea during the first week after weaning. All variables in standard hematology and clinical chemistry tests, as well as gross and microscopic structures, did not differ among the five groups of pigs. These results indicate that dietary supplementation with up to 4 % MSG is safe and improves growth performance in postweaning pigs.

Systematic review of herbs and dietary supplements for glycemic control in diabetes.

PubMed

Yeh, Gloria Y; Eisenberg, David M; Kaptchuk, Ted J; Phillips, Russell S

2003-04-01

To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.

Investigation of dietary supplements prevalence as complementary therapy: Comparison between hospitalized psoriasis patients and non-psoriasis patients, correlation with disease severity and quality of life.

PubMed

Yousefzadeh, Hadis; Mahmoudi, Mahmoud; Banihashemi, Mahnaz; Rastin, Maryam; Azad, Farahzad Jabbari

2017-08-01

Psoriasis patients are often displeased with traditional medical treatments and they may self-prescribe dietary supplements as an alternative or complementary treatments. We aimed to investigate the prevalence of self-medication of dietary supplements among psoriasis and non-psoriasis cases and its impact on disease severity and quality of life. This case-control study evaluated 252 records of psoriasis patients and 245 non-psoriasis cases. Dietary supplementation over last 30days and characteristics, including age, age at onset of disease, co-morbidities, smoking and education were recorded. Psoriasis area and severity index (PASI) and dermatology quality of life index (DLQI) were calculated. P value less than 0.05 was considered as significant level. This study consisted 138 psoriasis (females; 54) and 138 non-psoriasis cases (females; 50), aged between 21 and 91 years. Among psoriasis patients, 72% reported using at least one of dietary supplements, which was different from non-psoriasis cases (25.36%, P=0.01). Multivitamin/mineral supplements (MVM) were the most frequent used dietary supplements (26.81%) and the most common reasons for the consumption of these supplements were to maintain and improve health. The consumption of folic acid (21.73%), omega-3 fatty acids or fish oil (10.14%), herbs (12.31%) and vitamin E (1.44%) had the most frequencies after MVM. No significant differences in PASI and DLQI were found among patients with consumption of different supplements (P>0.05). There was non-significant and negative correlation between education and use of supplements (P=0.21, r=-0.02). Self-medicating of MVM over last 30days was prevalent among studied psoriasis patients. They took dietary supplements in order to improve and maintain their health. Copyright © 2017 Elsevier Ltd. All rights reserved.

UHPLC/HRMS analysis of African mango (Irvingia gabonensis) seeds, seed extracts, and African mango based dietary supplements

USDA-ARS?s Scientific Manuscript database

Dietary Supplements based on extract from Irvingia gabonensis (African Mango, or AM) seeds are one of the popular herbal weight loss dietary supplements in the US market. The extract from the AM seeds is believed to be a natural and healthy way to lose weight and improve overall health. However, the...

Quantitative determination of vinpocetine in dietary supplements

PubMed Central

French, John M. T.; King, Matthew D.

2017-01-01

Current United States regulatory policies allow for the addition of pharmacologically active substances in dietary supplements if derived from a botanical source. The inclusion of certain nootropic drugs, such as vinpocetine, in dietary supplements has recently come under scrutiny due to the lack of defined dosage parameters and yet unproven short- and long-term benefits and risks to human health. This study quantified the concentration of vinpocetine in several commercially available dietary supplements and found that a highly variable range of 0.6–5.1 mg/serving was present across the tested products, with most products providing no specification of vinpocetine concentrations. PMID:27319129

Regulatory and ethical issues with dietary supplements.

PubMed

Harris, I M

2000-11-01

Dietary supplements are commonly used, and many are effective or hold promise for treating various conditions. However, they do not require Food and Drug Administration (FDA) approval. Impurities and adulterants have been found in the products, mostly due to the lack of requirements for good manufacturing practices. In addition, as no standardization is required, the active ingredient may be absent or highly variable among manufacturers. The FDA published its 10-year plan for dietary supplements that addresses safety, labeling, boundaries, enforcement, research, and outreach. This endeavor, if put into place, will be instrumental in providing consumers with more confidence in the safety, composition, and labeling of dietary supplements.

Primary constituents of blue cohosh: quantification in dietary supplements and potential for toxicity.

PubMed

Rader, Jeanne I; Pawar, Rahul S

2013-05-01

Dietary supplements containing dried roots or extracts of the roots and/or rhizomes of blue cohosh (Caulophyllum thalictroides) are widely available. This botanical has a long history of use by Native Americans and its use continues to the present day. The primary constituents of blue cohosh are its alkaloids and saponins. The structures of the alkaloids magnoflorine, baptifoline, anagyrine, and N-methylcytisine have been known for many years. The last 10 years have seen a great increase in isolation and identification of the large number of saponins present in blue cohosh. Important developments in nuclear magnetic resonance techniques have contributed substantially to the increase in elucidation of the structures of the complex saponins. Several authors have described quantitative methods for both the alkaloids and saponins in blue cohosh. Such methods have made it possible to quantify these constituents in dietary supplements containing this botanical ingredient. Concentrations of both alkaloids and saponins vary substantially in dietary supplements of blue cohosh. The nicotinic alkaloid, N-methylcytisine, a potent toxicant, has been found in all dietary supplements of blue cohosh analyzed. The teratogenic alkaloid anagyrine has been found in some but not all dietary supplements.

Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ — Hawaii, 2013

PubMed Central

Johnston, David I.; Chang, Arthur; Viray, Melissa; Chatham-Stephens, Kevin; He, Hua; Taylor, Ethel; Wong, Linda L.; Schier, Joshua; Martin, Colleen; Fabricant, Daniel; Salter, Monique; Lewis, Lauren; Park, Sarah Y.

2015-01-01

Dietary supplements are increasingly marketed to and consumed by the American public for a variety of purported health benefits. On 9 September 2013, the Hawaii Department of Health (HDOH) was notified of a cluster of acute hepatitis and fulminant hepatic failure among individuals with exposure to the dietary supplement OxyELITE Pro™ (OEP). HDOH conducted an outbreak investigation in collaboration with federal partners. Physicians were asked to report cases, defined as individuals with acute onset hepatitis of unknown etiology on or after 1 April 2013, a history of weight-loss/muscle-building dietary supplement use during the 60 days before illness onset, and residence in Hawaii during the period of exposure. Reported cases’ medical records were reviewed, questionnaires were administered, and a product investigation, including chemical analyses and trace back, was conducted. Of 76 reports, 44 (58%) met case definition; of these, 36 (82%) reported OEP exposure during the two months before illness. No other common supplements or exposures were observed. Within the OEP-exposed subset, two patients required liver transplantation, and a third patient died. Excessive product dosing was not reported. No unique lot numbers were identified; there were multiple mainland distribution points, and lot numbers common to cases in Hawaii were also identified in continental states. Product analysis found consumed products were consistent with labeled ingredients; the mechanism of hepatotoxicity was not identified. We report one of the largest statewide outbreaks of dietary supplement-associated hepatotoxicity. The implicated product was OEP. The increasing popularity of dietary supplements raises the potential for additional clusters of dietary supplement-related adverse events. PMID:26538199

Dietary Lecithin Supplementation Can Improve the Quality of the M. Longissimus thoracis

PubMed Central

D’Souza, Darryl N.; Blake, Bronwyn L.; Williams, Ian H.; Mullan, Bruce P.; Pethick, David W.; Dunshea, Frank R.

2015-01-01

Simple Summary Meat tenderness and texture can be influenced by the connective tissue content. Dietary lecithin offers a means of improving fat digestibility of pigs and reducing the connective tissue of pork. This feeding study confirmed that dietary lecithin decreased the chewiness and improved the fatty acid composition of pork without impacting on growth performance of pigs. Therefore, dietary lecithin supplementation has the potential to improve the quality attributes of pork. Abstract Forty crossbred (Large White × Landrace × Duroc) female pigs (16.4 kg ± 0.94 kg) were used to investigate the effect of dietary lecithin supplementation on growth performance and pork quality. Pigs were randomly allocated to a commercial diet containing either 0, 3, 15 or 75 g lecithin/kg of feed during the grower and finisher growth phase. Pork from pigs consuming the diets containing 15 g and 75 g lecithin/kg had lower hardness (P < 0.001) and chewiness (P < 0.01) values compared to the controls. Dietary lecithin supplementation at 75 g/kg significantly increased (P < 0.05) the linoleic acid and reduced (P < 0.05) the myristic acid levels of pork compared to the control and the 3 g/kg and 15 g/kg lecithin supplemented treatments. Pigs fed the 75 g/kg lecithin supplemented diet had lower plasma cholesterol (P < 0.05) at slaughter compared to pigs fed the control diet and the 3 g/kg and 15 g/kg lecithin supplemented treatments. These data indicate that dietary lecithin supplementation has the potential to improve the quality attributes of pork from female pigs. PMID:26610579

Dietary Chromium Picolinate Supplementation Affects Growth, Whole-Body Composition, and Gene Expression Related to Glucose Metabolism and Lipogenesis in Juvenile Blunt Snout Bream, Megalobrama amblycephala.

PubMed

Ren, Mingchun; Mokrani, Ahmed; Liang, Hualiang; Ji, Ke; Xie, Jun; Ge, Xianping; Liu, Bo

2018-01-18

An 11-week feeding trial was carried out to investigate the effects of supplemented chromium picolinate (Cr-Pic) on the growth, whole-body composition, and relative mRNA expression related to lipogenesis and glucose metabolism in juvenile blunt snout bream. Seven isonitrogenous and isoenergetic diets with graded Cr supplementation levels were fed to triplicate groups. The final weight (FW), feed conversion ratio (FCR), and specific growth rate (SGR) were improved with increasing dietary Cr supplementation levels up to 0.4 mg/kg, and thereafter showed relatively constant. However, 12.0 mg/kg dietary Cr supplementation decreased growth and feed utilization. Based on SGR and FCR, the optimal dietary Cr supplementation level for the juvenile was estimated to be 0.28 mg/kg. Significantly higher plasma insulin levels were found in juvenile fed diets with 0.4 and 0.8 mg/kg Cr supplementation compared to those fed diet sans supplemented Cr. Plasma glucose levels decreased with increasing dietary Cr supplementation, and the lowest value was remarked in the group added 3.2 mg/kg of Cr. Adding 0.4-0.8 mg/kg Cr enhanced insulin receptor substrate 1 (IRS-1), phosphoinositide-3-kinase (PI3K), and pyruvate kinase (PK) and inhibited expression of phosphoenolpyruvate carboxykinase (PEPCK), glucose-6-phosphatase (G6Pase), and glycogen synthase (GS) mRNA levels. High dietary Cr (12.0 mg/kg) supplementation resulted in high G6Pase and PEPCK expression. The highest content of whole-body lipid was remarked in fish fed with 0.4 mg/kg dietary Cr, which related to the enhanced gene expression related to lipogenesis; thereafter, mRNA levels showed a diminishing trend. These findings indicate that optimum dietary Cr-Pic supplementation has a positive effect on growth and blood glucose homeostasis by modifying the mRNA levels related to glucose metabolism and lipogenesis in juvenile blunt snout bream.

Anthocyanin analyses of Vaccinium fruit dietary supplements

USDA-ARS?s Scientific Manuscript database

Vaccinium fruit ingredients within dietary supplements were identified by comparisons with anthocyanin analyses of known Vaccinium profiles (demonstration of anthocyanin fingerprinting). Available Vaccinium supplements were purchased and analyzed; their anthocyanin profiles (based on HPLC separation...

Prevalence, Adverse Events, and Factors Associated with Dietary Supplement and Nutritional Supplement Use by US Navy and Marine Corps Personnel

DTIC Science & Technology

2016-04-12

personnel. Objective The aim of this cross-sectional study was to investigate dietary and nutri- tional supplement use in Navy and Marine Corps personnel...been published regularly,7-10 and a recent study of a nationally representative sample estimated that 23,005 emergency department visits and 2,154...informa- tion on dietary supplement use by service members.21 To this end, previous studies were conducted in Army,17 Air Force,18 and Coast Guard19

Do Studies Evaluating QT/QTc Interval Prolongation with Dietary Supplements Meet FDA Standards: A Systematic Review.

PubMed

Nguyen, Tinh An; Kurian, Amy; Leong, Jessica; Patel, Umang M; Shah, Sachin A

2017-07-04

Dietary supplement use is continuously increasing, but the safety evaluation of these products remains partial. While dietary supplements have no mandate for assessing cardiovascular safety, all new drug entities (NDE) are required to undergo a thorough QT/corrected QT (QTc) assessment to determine their propensity to impact cardiac repolarization. Independent investigators and manufacturers of dietary supplements voluntarily initiate safety studies; however, the quality of these studies is controversial. We sought to compare studies evaluating the QT/QTc effects of dietary supplements based on the International Conference of Harmonization (ICH)-E14 recommendations for NDE. Twenty-six published dietary supplement studies assessed QT/QTc interval prolongation. Sample sizes ranged from nine subjects to 206 among the 15 crossover studies, six parallel design studies, and five observational studies. A plan to account for electrocardiogram (ECG) morphological abnormalities was included in 10 studies, and two studies reported cardiovascular adverse events. Eight studies found a significant change in QT/QTc intervals. The majority of studies included in this review contained many of the critical elements recommended by the ICH E14, which includes the U.S. Food and Drug Administration guidance document for QT/QTc interval assessment. Compared with the thorough QT (TQT) standards, studies are typically well performed but can be bolstered by some study design changes. More than 30% of the included studies showed some degree of ECG changes, suggesting the need for continued cardiovascular safety assessment of dietary supplements.

[A new method for safety monitoring of natural dietary supplements--quality profile].

PubMed

Wang, Juan; Wang, Li-Ping; Yang, Da-Jin; Chen, Bo

2008-07-01

A new method for safety monitoring of natural dietary supplements--quality profile was proposed. It would convert passive monitoring of synthetic drug to active, and guarantee the security of natural dietary supplements. Preliminary research on quality profile was completed by high performance liquid chromatography (HPLC) and mass spectrometry (MS). HPLC was employed to analyze chemical constituent profiles of natural dietary supplements. The separation was completed on C18 column with acetonitrile and water (0.05% H3PO4) as mobile phase, the detection wavelength was 223 nm. Based on HPLC, stability of quality profile had been studied, and abnormal compounds in quality profile had been analyzed after addition of phenolphthalein, sibutramine, rosiglitazone, glibenclamide and gliclazide. And by MS, detector worked with ESI +, capillary voltage: 3.5 kV, cone voltage: 30 V, extractor voltage: 4 V, RF lens voltage: 0.5 V, source temperature: 105 degrees C, desolvation temperature: 300 degrees C, desolvation gas flow rate: 260 L/h, cone gas flow rate: 50 L/h, full scan mass spectra: m/z 100-600. Abnormal compound in quality profile had been analyzed after addition of N-mono-desmethyl sibutramine. Quality profile based on HPLC had good stability (Similarity > 0.877). Addition of phenolphthalein, sibutramine, rosiglitazone, glibenclamide and gliclazide in natural dietary supplements could be reflected by HPLC, and addition of N-mono-desmethyl sibutramine in natural dietary supplements could be reflected by MS. Quality profile might monitor adulteration of natural dietary supplements, and prevent addition of synthetic drug after "approval".

Anaphylactic reaction to a dietary supplement containing willow bark.

PubMed

Boullata, Joseph I; McDonnell, Patrick J; Oliva, Cynthia D

2003-06-01

To report a case of anaphylaxis resulting from the use of a willow bark-containing dietary supplement in a patient with a history of an aspirin allergy. A 25-year-old white woman presented to the emergency department of a community teaching hospital with anaphylaxis requiring epinephrine, diphenhydramine, methylprednisolone, and volume resuscitation to which she responded favorably. Medication history revealed that she had ingested 2 capsules of Stacker 2 (NVE Pharmaceuticals, Newton, NJ), a dietary supplement promoted for weight loss, prior to experiencing her initial symptoms. Among other active ingredients, this product contains willow bark. Of significance is that this patient also reported a history of allergy to acetylsalicylic acid. No other causes for anaphylaxis were identified. She continued to receive routine supportive care and the remaining hospital course was uncomplicated. Dietary supplements, including herbal products, are used by many individuals who consider them to be inherently safe despite limited regulatory oversight by the Food and Drug Administration. While there may be value to specific botanical ingredients, a potential for adverse effects also exists. The popular product consumed by our patient is used for weight loss and contains willow bark, a source of salicylates. Based on the Naranjo probability scale, it is probable that this case of anaphylaxis was due to this dietary supplement. The use of any willow bark-containing dietary supplement may present a risk of anaphylactic reaction to patients with a history of allergy to salicylates. Clinicians need to recognize the potential for adverse effects from dietary supplements.

Vitamin and Mineral Supplements Have a Nutritionally Significant Impact on Micronutrient Intakes of Older Adults Attending Senior Centers

USDA-ARS?s Scientific Manuscript database

Background: Older adults frequently report use of vitamin and mineral (VM) supplements, though the impact of supplements on dietary adequacy remains largely unknown. Despite possible improvements in dietary intake, concern remains over potential excessive nutrient consumption from VM supplement us...

Use of Nonvitamin, Nonmineral Dietary Supplements among College Students.

ERIC Educational Resources Information Center

Newberry, Heather; Beerman, Kathy; Duncan, Sam; McGuire, Michelle; Hillers, Virginia

2001-01-01

Assessed college students' use of nonvitamin, nonmineral (NVNM) dietary supplements. Student surveys indicated that nearly half of the respondents took NVNM supplements, most frequently echinacea, ginseng, and St. John's wort. Over 80 percent had acceptable body mass index values. Users and nonusers of NVNM supplements did not differ significantly…

Consumer usage and reasons for using dietary supplements: report of a series of surveys.

PubMed

Dickinson, Annette; Blatman, Judy; El-Dash, Neale; Franco, Julio C

2014-01-01

Consumer usage of dietary supplements is prevalent in the United States, and total usage is higher than reported in recent National Health and Nutrition Examination Surveys (NHANES), because these surveys capture usage only in the 30 days prior to the respondent's interview and do not capture occasional and seasonal use throughout the year. We report data from a series of consumer surveys on the full extent of dietary supplement use, on the reasons for supplement use, and on the products most commonly taken, as well as other health habits of supplement users. The Council for Responsible Nutrition (CRN), a trade association of the dietary supplement industry, has contracted with Ipsos Public Affairs to conduct consumer surveys annually since 2000. The surveys have been administered online since 2007 to about 2000 subjects each year. We report 5 years of data (2007 to 2011) on the prevalence of dietary supplement use, as well as more detailed data from the 2011 survey on the products used, the reasons for using supplements, and other health habits of supplement users. The prevalence of supplement use fluctuated within the range of 64% to 69% from 2007 to 2011, and the prevalence of regular supplement use ranged from 48% to 53%, with no statistically significant differences from year to year. Over the 5-year period, the percentage of respondents who said that they regularly used a variety of supplements increased from 28% to 36%, and the increase from 2010 to 2011 was statistically significant. The percentage of respondents who said that they regularly used only a multivitamin, as opposed to a variety of supplements, declined from 24% to 17%, and the decrease from 2007 to 2008 was statistically significant. Detailed results from the 2011 survey confirm that supplement use increases with age and is higher in women than in men. Vitamin or mineral supplements were used by 67% of all respondents in 2011, specialty supplements by 35%, botanicals by 23%, and sports supplements by 17%. Among supplement users, multivitamins were the most commonly used supplement (71%), followed by omega-3 or fish oil (33%), calcium (32%), vitamin D (32%), and vitamin C (32%). The reasons most often cited for supplement use were for overall health and wellness (58%) and to fill nutrient gaps in the diet (42%). Supplement users were significantly more likely than nonusers to say that they try to eat a balanced diet, visit their doctor regularly, get a good night's sleep, exercise regularly, and maintain a healthy weight. Annual consumer surveys over a period of 5 years show that dietary supplement use is somewhat more prevalent in the United States than has been reported in the NHANES surveys, when occasional and seasonal use are taken into account, in addition to regular use. Most dietary supplement users take a multivitamin, and many take a variety of products. The primary reasons given for supplement use are for overall health and wellness or to fill nutrient gaps. Users of dietary supplements are more likely than nonusers to adopt a variety of healthy habits, indicating that supplement use is part of an overall approach to living healthy.

The history of efforts to regulate dietary supplements in the USA.

PubMed

Swann, John P

2016-01-01

This review examines the emergence of dietary supplements and how the Food and Drug Administration (FDA) attempted to regulate these, beginning with the arrival of vitamins and how these were managed under the 1906 Food and Drugs Act, and ending with the seismic influence of the 1994 Dietary Supplement Health and Education Act (DSHEA). Included are the impact of major laws, key court decisions, and the construction of the FDA's supplement actions and rules from the 1920s to the 1990s for products that were neither drugs nor typical foods. Stiff resistance to the regulations by supplement manufacturers, trade associations, politicians, and especially the public at large is an important part of this story. The paper closes with the passage of DSHEA and how it literally changed the definition and parameters of control of dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Can fortified foods and snacks increase the energy and protein intake of hospitalised older patients? A systematic review.

PubMed

Mills, S R; Wilcox, C R; Ibrahim, K; Roberts, H C

2018-06-01

Undernutrition affects over 44% of hospitalised older people, who often dislike oral nutritional supplements (ONS). This review summarises the evidence for an alternative strategy, using energy and protein dense meals (via fortification) or snacks (supplementation) to increase the dietary energy and protein intake of older inpatients. A search was conducted through PubMed, EMBASE, CINAHL and the Cochrane database of systematic reviews (May 1996 to May 2016) that used fortification or supplementation to increase the energy or protein intake of patients (mean age ≥60 years) in hospitals or rehabilitation centres. Ten articles (546 patients, mean age 60-83 years) were identified. Compared with usual nutritional care, six studies using either energy or protein based fortification and supplementation significantly increased intake of energy (250-450 kcal day -1 ) or protein (12-16 g day -1 ). Two studies enriched menus with both energy and protein, and significantly increased both energy (698 kcal day -1 and 21 kJ kg -1 ) and protein (16 g and 0.2 g kg -1 ) intake compared to usual care. ONS was similar to supplementation in one study but superior to fortification in another. Four studies reported good acceptability of enriched products and two studies that found they were cost-effective. Compared with usual nutritional care, energy- and protein-based fortification and supplementation could be employed as an effective, well-tolerated and cost-effective intervention to improve dietary intake amongst older inpatients. This strategy may be particularly useful for patients with cognitive impairment who struggle with ONS, and clinical trials are required to compare these approaches and establish their impact on functional outcomes. © 2018 The British Dietetic Association Ltd.

Impact of supplementation with amino acids or their metabolites on muscle wasting in patients with critical illness or other muscle wasting illness: a systematic review.

PubMed

Wandrag, L; Brett, S J; Frost, G; Hickson, M

2015-08-01

Muscle wasting during critical illness impairs recovery. Dietary strategies to minimise wasting include nutritional supplements, particularly essential amino acids. We reviewed the evidence on enteral supplementation with amino acids or their metabolites in the critically ill and in muscle wasting illness with similarities to critical illness, aiming to assess whether this intervention could limit muscle wasting in vulnerable patient groups. Citation databases, including MEDLINE, Web of Knowledge, EMBASE, the meta-register of controlled trials and the Cochrane Collaboration library, were searched for articles from 1950 to 2013. Search terms included 'critical illness', 'muscle wasting', 'amino acid supplementation', 'chronic obstructive pulmonary disease', 'chronic heart failure', 'sarcopenia' and 'disuse atrophy'. Reviews, observational studies, sport nutrition, intravenous supplementation and studies in children were excluded. One hundred and eighty studies were assessed for eligibility and 158 were excluded. Twenty-two studies were graded according to standardised criteria using the GRADE methodology: four in critical care populations, and 18 from other clinically relevant areas. Methodologies, interventions and outcome measures used were highly heterogeneous and meta-analysis was not appropriate. Methodology and quality of studies were too varied to draw any firm conclusion. Dietary manipulation with leucine enriched essential amino acids (EAA), β-hydroxy-β-methylbutyrate and creatine warrant further investigation in critical care; EAA has demonstrated improvements in body composition and nutritional status in other groups with muscle wasting illness. High-quality research is required in critical care before treatment recommendations can be made. © 2014 The British Dietetic Association Ltd.

Gut microbiota analysis of juvenile genetically improved farmed tilapia (Oreochromis niloticus) by dietary supplementation of different resveratrol concentrations.

PubMed

Zheng, Yao; Wu, Wei; Hu, Gengdong; Qiu, Liping; Meng, Shunlong; Song, Chao; Fan, Limin; Zhao, Zhixiang; Bing, Xuwen; Chen, Jiazhang

2018-06-01

The genetically improved farmed tilapia (GIFT, Oreochromis niloticus) is cultured widely for production of freshwater fish in China, while streptococcosis, likely related to pathogenic infections, occurs frequently in juvenile, mother, and operated GIFT. The gut microbiota plays an important role in nutrient digestibility in animals, and resveratrol (RES) has been used in feed for different freshwater fish species. Therefore, understanding changes in the tilapia gut microbiota across different concentrations of dietary RES supplementation is extremely important. The gut microbiota population in tilapia at 45 d after supplementation with different concentrations (0, 0.025, 0.05, 0.1 g/kg) of dietary RES was assessed by 16S rDNA gene sequencing. A total of 5445 operational taxonomic units were identified from all samples, and 14 phyla and 81 families were identified from all fecal samples. The bacteria of the phylum Firmicutes were significantly enriched in the 0.025 g/kg RES group when compared with the controls. Proteobacteria, Firmicutes and Cyanobacteria were the most dominant three phyla in all samples. With the increasing concentrations, the proportion of beneficial microbial taxa (Acetobacteraceae and Methylobacteriaceae) increased, whereas the proportion of harmful microbial taxa decreased, eg. Streptococcaceae except for 0.1 g/kg RES groups. RES did not affect the richness and diversity in tilapia gut microbiota. These findings provide information on the diversity and differences in GIFT gut microbiota database, and may contribute to developing strategies for management of diseases and long-term sustainability of O. niloticus culture. Copyright © 2018. Published by Elsevier Ltd.

[A Systematic Review to Identify Unacceptable Intake Levels of Vitamin B6 among Patients Taking Levodopa].

PubMed

Sato, Yoko; Yasumiishi, Chiaki; Chiba, Tsuyoshi; Umegaki, Keizo

2017-01-01

The interaction of levodopa and vitamin B6 is a well-known issue. This study investigated the incidence of unacceptable intake levels of vitamin B6 among levodopa users by means of a systematic review. We searched two databases (PubMed and "Igaku Chuo Zasshi") for articles about adverse events due to the interaction of levodopa and vitamin B6 published up to August 2017. Of 98 citations retrieved, 11 studies met the selection criteria. The results indicated that a vitamin B6 intake level of more than 50 mg/day could reduce the efficacy of levodopa. The recommended intake of vitamin B6 for Japanese adults is 1.4 mg/day for men and 1.2 mg/day for women. Therefore, the acceptable intake of vitamin B6 for levodopa patients would be within the range of the recommended intake level, which is also within the usual range in foods in Japan, except for dietary supplements or health foods. Levodopa users should be cautious about taking dietary supplements and over-the-counter drugs.

The Content of Mercury in Herbal Dietary Supplements.

PubMed

Brodziak-Dopierała, Barbara; Fischer, Agnieszka; Szczelina, Wioletta; Stojko, Jerzy

2018-01-17

The dietary supplement market in Poland has been growing rapidly, and the number of registered products and their consumption increases steadily. Among the most popular and the easiest to get are herbal supplements, available in any supermarket. The aim of this paper was to investigate the mercury content in the herbal supplements. The dietary supplements that have been examined (24) are available on the Polish market and contain one or more herbal ingredients. Supplements were pulverized in porcelain mortar and identified by AMA 254 atomic absorption spectrometer. The range of variations for all tested supplements was within 0.02-4293.07 μg/kg. The arithmetic mean of the total result was 193.77 μg/kg. A higher mercury content then this mean was found in preparations-bamboo shoots and alga Chlorella pyrenoidosa. The studies have shown that mercury is present in every examined herbal supplement, and its content exceeds in two preparations (with bamboo and alga) the permissible limit of 0.10 mg/kg. There were statistically significant differences in the occurrence of mercury depending on the herbal ingredient in the supplement. The lowest content was found in the preparation with Tanacetum parthenium and the highest with bamboo shoots. The mercury content in the tested herbal supplements was statistically significant in the form of a supplement-a tablet and a capsule. Daily, weekly, monthly, and yearly consumption of mercury with examined supplements was calculated-the results did not exceed the PTWI-provisional tolerable weekly intake of mercury. To increase consumer safety, it is imperative to conduct further research on dietary supplements and implement a stricter quality control of the dietary supplements.

Use of dietary and performance-enhancing supplements among male fitness center members in Riyadh: A cross-sectional study.

PubMed

AlRuthia, Yazed; Balkhi, Bander; Alrasheed, Marwan; Altuwaijri, Ahmed; Alarifi, Mohammad; Alzahrani, Huda; Mansy, Wael

2018-01-01

This study aimed to explore the health beliefs and patterns of dietary supplement usage among fitness center members. This cross-sectional study was conducted in four large indoor fitness centers in Riyadh, Saudi Arabia. This study involved male fitness center members aged ≥18 years with no speech or hearing disabilities. In-person interviews were conducted with fitness center members who agreed to participate using a newly developed questionnaire. Information on participants' sociodemographics (e.g., age and education), smoking status, health status, exercise frequency, average time spent exercising, different supplements used, used supplements sources, and health beliefs regarding dietary supplements were obtained. A total of 445 fitness center members agreed to participate, and 198 of them reported taking dietary supplements. Most participants were between the age of 18 and 25 years (66%), had a college degree (74%), non-smokers (77%), healthy (84%), and perform exercise at least thrice weekly (52%) for at least 1 hour (63%). The percentage of participants who had favorable health views on dietary supplements was significantly higher among the supplement users than among the non-users (P<0.0001). Proteins, multivitamins, amino acids, and omega 3 fatty acids were the most commonly reported supplements used. Almost 30% of the supplement users reported buying them overseas, 28% online, 25% from a pharmacy or supplement store, 19% from a medical clinic, and 17% from peddlers. Public health campaigns are needed to educate the public on the potential harmful effects of supplements if purchased from an unofficial seller or taken without seeking medical advice before using them.

Dietary supplements and disease prevention: a global overview

USDA-ARS?s Scientific Manuscript database

Undernutrition and micronutrient malnutrition are prevalent conditions that affect global public health. Dietary supplements are widely used in many developed countries. However, it remains unclear whether supplementation with individual or combined vitamins, minerals, and other nutrients are effe...

Effects of dietary supplementation of resveratrol on performance, egg quality, yolk cholesterol and antioxidant enzyme activity of laying hens.

PubMed

Feng, Z H; Gong, J G; Zhao, G X; Lin, X; Liu, Y C; Ma, K W

2017-10-01

1. This experiment was conducted to evaluate the effects of dietary supplementation of resveratrol on laying performance, egg quality, egg yolk cholesterol and antioxidant enzyme activities of laying hens. 2. A total of 360 Beijing PINK-1 laying hens (60 weeks old) were randomly distributed among five dietary treatments, each of which included 6 replicates of 12 hens. Dietary treatments were basal diet supplemented with 0 (control), 0.5, 1.0, 2.0 and 4.0 g/kg diet resveratrol. The study lasted for 9 weeks including 1 week of adaptation and 8 weeks of the main experimental period. 3. The results indicated that dietary resveratrol significantly improved feed conversion ratios during 5-8 weeks and 1-8 weeks of the trial. Increasing dietary concentrations of the resveratrol linearly improved Haugh unit and albumen height of eggs. 4. The content of total cholesterol (TC), total triglyceride (TG), low density lipoprotein cholesterol (LDL-C), very low density lipoprotein cholesterol (VLDL-C) in serum and cholesterol in yolk was significantly decreased by dietary resveratrol, and there were significant linear correlations between these indexes and resveratrol supplemental levels. 5. Dietary resveratrol supplementation significantly improved serum Glutathione peroxidase (GSH-Px) enzyme activity and decreased serum malondialdehyde (MDA) content in groups with 2.0 and 4.0 g/kg resveratrol as compared to the control, respectively. However, supplementation of resveratrol did not affect the activity of serum superoxide dismutase (SOD). 6. It is concluded that resveratrol supplementation has a positive effect on performance, lipid-related traits and antioxidant activity of laying hens.

Effects of Dietary Crude Protein Levels and Cysteamine Supplementation on Protein Synthetic and Degradative Signaling in Skeletal Muscle of Finishing Pigs.

PubMed

Zhou, Ping; Zhang, Lin; Li, Jiaolong; Luo, Yiqiu; Zhang, Bolin; Xing, Shen; Zhu, Yuping; Sun, Hui; Gao, Feng; Zhou, Guanghong

2015-01-01

Dietary protein levels and cysteamine (CS) supplementation can affect growth performance and protein metabolism of pigs. However, the influence of dietary protein intake on the growth response of CS-treated pigs is unclear, and the mechanisms involved in protein metabolism remain unknown. Hence, we investigated the interactions between dietary protein levels and CS supplementation and the effects of dietary crude protein levels and CS supplementation on protein synthetic and degradative signaling in skeletal muscle of finishing pigs. One hundred twenty barrows (65.84 ± 0.61 kg) were allocated to a 2 × 2 factorial arrangement with five replicates of six pigs each. The primary variations were dietary crude protein (CP) levels (14% or 10%) and CS supplemental levels (0 or 700 mg/kg). The low-protein (LP) diets (10% CP) were supplemented with enough essential amino acids (EAA) to meet the NRC AA requirements of pigs and maintain the balanced supply of eight EAA including lysine, methionine, threonine, tryptophan, valine, phenylalanine, isoleucine, and leucine. After 41 days, 10 pigs per treatment were slaughtered. We found that LP diets supplemented with EAA resulted in decreased concentrations of plasma somatostatin (SS) (P<0.01) and plasma urea nitrogen (PUN) (P<0.001), while dietary protein levels did not affect other traits. However, CS supplementation increased the average daily gain (P<0.001) and lean percentage (P<0.05), and decreased the feed conversion ratio (P<0.05) and back fat (P<0.05). CS supplementation also increased the concentrations of plasma insulin-like growth factor 1 (IGF-1) (P<0.001), and reduced the concentrations of leptin, SS, and PUN (P<0.001). Increased mRNA abundance of Akt1 and IGF-1 signaling (P<0.001) and decreased mRNA abundance of Forkhead Box O (FOXO) 4 (P<0.01) and muscle atrophy F-box (P<0.001) were observed in pigs receiving CS. Additionally, CS supplementation increased the protein levels for the phosphorylated mammalian target of rapamycin (mTOR), eIF-4E binding protein 1, and ribosomal protein S6 kinase 1 (P<0.001). There were no interactions between dietary protein levels and CS supplementation for all traits. In conclusion, dietary protein levels and CS supplementation influenced growth and protein metabolism through independent mechanisms in pigs. In addition, LP diets supplemented with EAA did not affect growth performance and other traits except the concentrations of SS and PUN probably through maintenance of protein synthesis and degradation signaling. Moreover, CS supplementation improved growth performance by increasing plasma IGF-1 concentrations possibly through alterations of mTOR and Akt/FOXO signaling pathways in skeletal muscle of finishing pigs.

Oxaloacetate supplementation increases lifespan in Caenorhabditis elegans through an AMPK/FOXO-dependent pathway

PubMed Central

Williams, David S.; Cash, Alan; Hamadani, Lara; Diemer, Tanja

2010-01-01

Summary Reduced dietary intake increases lifespan in a wide variety of organisms. It also retards disease progression. We tested whether dietary supplementation of citric acid cycle metabolites could mimic this lifespan effect. We report that oxaloacetate supplementation increased lifespan in Caenorhabditis elegans. The increase was dependent on the transcription factor, FOXO/DAF-16, and the energy sensor, AMP-activated protein kinase, indicating involvement of a pathway that is also required for lifespan extension through dietary restriction. These results demonstrate that supplementation of the citric acid cycle metabolite, oxaloacetate, influences a longevity pathway, and suggest a tractable means of introducing the health-related benefits of dietary restriction. PMID:19793063

Evaluation of Dietary Intakes and Supplement Use in Paralympic Athletes

PubMed Central

Madden, Robyn F.; Shearer, Jane

2017-01-01

Dietary intakes and supplement use in Paralympic athletes remains largely unexplored, and specialized recommendations are lacking. The aim of this study was to evaluate nutrient intakes and supplement use in high-performance athletes with physical disabilities using three-day food records and a validated dietary supplement use questionnaire. A secondary aim examined gender differences in nutrient and supplement intakes. Male (n = 18) and female (n = 22) athletes were recruited from nine Paralympic sports through sporting organizations, coaches, and social media. Athletes generally met able-bodied recommendations for macronutrients. Male and female athletes often failed to meet the Recommended Dietary Allowance (RDA) or Adequate Intake (AI) for vitamin D, vitamin E, pantothenic acid, magnesium, and potassium. On average, females did not meet the RDA for iron and calcium, whereas males did not meet the RDA for vitamin A and folate. Commonly consumed supplements were vitamin D, protein powder, sport bars, and sport drinks. Analysis of diet and supplement use within this population shows several micronutrient deficiencies and irregular use of specific supplements. Athlete support and education is required to optimize nutrition in Paralympic athletes. PMID:29160809

Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products.

PubMed

Fialkow, Jonathan

2016-08-01

Omega-3 fatty acid products are available as prescription formulations (icosapent ethyl, omega-3-acid ethyl esters, omega-3-acid ethyl esters A, omega-3-carboxylic acids) and dietary supplements (predominantly fish oils). Most dietary supplements and all but one prescription formulation contain mixtures of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Products containing both EPA and DHA may raise low-density lipoprotein cholesterol (LDL-C). In clinical trials, the EPA-only prescription product, icosapent ethyl, did not raise LDL-C compared with placebo. To correct a common misconception, it is important to note that omega-3 fatty acid dietary supplements are not US FDA-approved over-the-counter drugs and are not required to demonstrate safety and efficacy prior to marketing. Conversely, prescription products are supported by extensive clinical safety and efficacy investigations required for FDA approval and have active and ongoing safety monitoring programs. While omega-3 fatty acid dietary supplements may have a place in the supplementation of diet, they generally contain lower levels of EPA and DHA than prescription products and are not approved or intended to treat disease. Perhaps due to the lack of regulation of dietary supplements, EPA and DHA levels may vary widely within and between brands, and products may also contain unwanted cholesterol or fats or potentially harmful components, including toxins and oxidized fatty acids. Accordingly, omega-3 fatty acid dietary supplements should not be substituted for prescription products. Similarly, prescription products containing DHA and EPA should not be substituted for the EPA-only prescription product, as DHA may raise LDL-C and thereby complicate the management of patients with dyslipidemia.

Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ - Hawaii, 2013.

PubMed

Johnston, David I; Chang, Arthur; Viray, Melissa; Chatham-Stephens, Kevin; He, Hua; Taylor, Ethel; Wong, Linda L; Schier, Joshua; Martin, Colleen; Fabricant, Daniel; Salter, Monique; Lewis, Lauren; Park, Sarah Y

2016-01-01

Dietary supplements are increasingly marketed to and consumed by the American public for a variety of purported health benefits. On 9 September 2013, the Hawaii Department of Health (HDOH) was notified of a cluster of acute hepatitis and fulminant hepatic failure among individuals with exposure to the dietary supplement OxyELITE Pro™ (OEP). HDOH conducted an outbreak investigation in collaboration with federal partners. Physicians were asked to report cases, defined as individuals with acute onset hepatitis of unknown etiology on or after 1 April 2013, a history of weight-loss/muscle-building dietary supplement use during the 60 days before illness onset, and residence in Hawaii during the period of exposure. Reported cases' medical records were reviewed, questionnaires were administered, and a product investigation, including chemical analyses and traceback, was conducted. Of 76 reports, 44 (58%) met case definition; of these, 36 (82%) reported OEP exposure during the two months before illness. No other common supplements or exposures were observed. Within the OEP-exposed subset, two patients required liver transplantation, and a third patient died. Excessive product dosing was not reported. No unique lot numbers were identified; there were multiple mainland distribution points, and lot numbers common to cases in Hawaii were also identified in continental states. Product analysis found consumed products were consistent with labeled ingredients; the mechanism of hepatotoxicity was not identified. We report one of the largest statewide outbreaks of dietary supplement-associated hepatotoxicity. The implicated product was OEP. The increasing popularity of dietary supplements raises the potential for additional clusters of dietary supplement-related adverse events. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Dietary supplements for body-weight reduction: a systematic review.

PubMed

Pittler, Max H; Ernst, Edzard

2004-04-01

Compliance with conventional weight-management programs is notoriously poor, and a plethora of over-the-counter slimming aids are sold with claims of effectiveness. The objective of the study was to assess the evidence from rigorous clinical trials, systematic reviews, and meta-analyses on the effectiveness of dietary supplements in reducing body weight. The study was a systematic review. Literature searches were conducted on Medline, Embase, Amed, Cinahl, and the Cochrane Library until March 2003. Hand searches of medical journals, the authors' own files, and bibliographies of identified articles were conducted. There were no restrictions regarding the language of publication. The screening of studies, selection, validation, data extraction, and the assessment of methodologic quality were performed independently by the 2 reviewers. To be included, trials were required to be randomized and double-blind. Systematic reviews and meta-analyses of dietary supplements were included if they were based on the results of randomized, double-blind trials. Five systematic reviews and meta-analyses and 25 additional trials were included and reviewed. Data on the following dietary supplements were identified: chitosan, chromium picolinate, Ephedra sinica, Garcinia cambogia, glucomannan, guar gum, hydroxy-methylbutyrate, plantago psyllium, pyruvate, yerba maté, and yohimbe. The reviewed studies provide some encouraging data but no evidence beyond a reasonable doubt that any specific dietary supplement is effective for reducing body weight. The only exceptions are E. sinica- and ephedrine-containing supplements, which have been associated with an increased risk of adverse events. The evidence for most dietary supplements as aids in reducing body weight is not convincing. None of the reviewed dietary supplements can be recommended for over-the-counter use.

Biological Reactive Intermediates (BRIs) Formed from Botanical Dietary Supplements

PubMed Central

Dietz, Birgit M.; Bolton, Judy L.

2013-01-01

The use of botanical dietary supplements is increasingly popular, due to their natural origin and the perceived assumption that they are safer than prescription drugs. While most botanical dietary supplements can be considered safe, a few contain compounds, which can be converted to reactive biological reactive intermediates (BRIs) causing toxicity. For example, sassafras oil contains safrole, which can be converted to a reactive carbocation forming genotoxic DNA adducts. Alternatively, some botanical dietary supplements contain stable BRIs such as simple Michael acceptors that react with chemosensor proteins such as Keap1 resulting in induction of protective detoxification enzymes. Examples include curcumin from turmeric, xanthohumol from hops, and Z-ligustilide from dang gui. Quinones (sassafras, kava, black cohosh), quinone methides (sassafras), and epoxides (pennyroyal oil) represent BRIs of intermediate reactivity, which could generate both genotoxic and/or chemopreventive effects. The biological targets of BRIs formed from botanical dietary supplements and their resulting toxic and/or chemopreventive effects are closely linked to the reactivity of BRIs as well as dose and time of exposure. PMID:20970412

LC-QTOF-MS Analysis and Activity Profiles of Popular Antioxidant Dietary Supplements in Terms of Quality Control

PubMed Central

Baj, Tomasz; Sawicki, Rafal; Wanat, Aleksandra; Wojtanowski, Krzysztof Kamil; Ginalska, Grazyna; Zgorka, Grazyna; Szymanska, Jolanta

2017-01-01

The dietary supplements with claimed antioxidant activity constitute a substantial part of the dietary supplement market. In this study, we performed the LC-QTOF-MS analysis and investigated the activity profiles of popular antioxidant dietary supplements from different chemical groups in terms of quality control. The commonly used antioxidant tests and statistical analysis revealed that substantial part of the results was comparable if 1 g sample was considered, but while comparing single and daily doses, significant differences in antioxidant values were noticed in all assays. The best antioxidant activity was obtained in ORAC assay (from 142 to 13814 μM of Trolox equivalents per 1 g of sample), and the strongest correlation occurred between TPC and ORAC. The LC-QTOF-MS analysis revealed that catechins were present in samples having the best antioxidant activity and that dietary supplements showing the weakest activity contained very small amount of any chemical constituents. PMID:28642814

[Dietary supplements as a treatment for cervical cancer: a systematic review].

PubMed

Arellano Ortiz, Ana Lidia; Jiménez Vega, Florinda; Salcedo Vargas, Mauricio

2013-11-01

Cervical cancer and cervical intraepithelial neoplasia (CIN) require a careful selection of conventional and complementary therapies. The inclusion of dietary supplements within the aforementioned treatments set the tone within treatments. However, there are no reports of what kind of supplements could be used to provide a better response to the disease in these patients. In this review, we analyze clinical trials of the past 20 years that evaluated dietary supplements on this population, with the objective to raise awareness on which of them are viable to be administered. We performed a search for clinical trials that used a dietary supplement in women with cervical cancer and some degree of NIC analyzing them how to use the supplement, the conventional treatment, deficiency of the nutrient or compound to be evaluated, the characteristics of the population, the clinical trial and the supplement, as well as dosage and their effects. Twenty were in total the number of studies reviewed. The articles were classified according to the nature of the supplement: Retinoids, vitamin E, probiotics, indoles, multivitamin, folic acid and selenium. Some supplements were found to be effective in the treatment of cervical cancer and CIN. However, their effect depends on specific factors of the disease. The correct management of dietary supplements is an effective aid to help the patient with cancer and therefore, it is important to define what complementary therapies can be used for this population. Copyright AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

Low Dose Ferrous Gluconate Supplement Fails to Alter the Iron Status of Female Officers-In-Training

DTIC Science & Technology

2005-07-01

guidelines are that total dietary fat intake should contribute no more than 28% of dietary energy with no more than 10% being from saturated fatty...13 3.4 Does alcohol, dietary iron intake , initial iron status or inflammation influence the effect of the supplement...13 3.4.2 Dietary iron intake

Adverse Effects of Nutraceuticals and Dietary Supplements.

PubMed

Ronis, Martin J J; Pedersen, Kim B; Watt, James

2018-01-06

Over 70% of Americans take some form of dietary supplement every day, and the supplement industry is currently big business, with a gross of over $28 billion. However, unlike either foods or drugs, supplements do not need to be registered or approved by the US Food and Drug Administration (FDA) prior to production or sales. Under the Dietary Supplement Health and Education Act of 1994, the FDA is restricted to adverse report monitoring postmarketing. Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast, a small number of these products have the potential to produce significant toxicity. In addition, patients often do not disclose supplement use to their physicians. Therefore, the risk of adverse drug-supplement interactions is significant. An overview of the major supplement and nutraceutical classes is presented here, together with known toxic effects and the potential for drug interactions.

Decision-making patterns for dietary supplement purchases among women aged 25 to 45 years.

PubMed

Miller, Carla K; Russell, Teri; Kissling, Grace

2003-11-01

Women frequently consume dietary supplements but the criteria used to select supplements have received little investigation. This research identified the decision-making criteria used for dietary supplements among women aged 25 to 45 years who consumed a supplement at least four times per week. Participants (N=51) completed an in-store shopping interview that was audiotaped, transcribed, and analyzed qualitatively for the criteria used to make supplement selections. Qualitative analysis revealed 10 key criteria and the number of times each person used each criterion was quantified. Cluster analysis identified five homogeneous subgroups of participants based on the criteria used. These included brand shopper, bargain shopper, quality shopper, convenience shopper, and information gatherer. Supplement users vary in the criteria used to make point-of-purchase supplement selections. Dietetics professionals can classify supplement users according to the criteria used to tailor their nutrition counseling and better meet the educational needs of consumers.

Differences by race/ethnicity in older adults’ beliefs about the relative importance of dietary supplements versus prescription medications: Results from the SURE study

PubMed Central

Albright, Cheryl L.; Schembre, Susan M.; Steffen, Alana D.; Wilkens, Lynne R.; Monroe, Kristine R.; Yonemori, Kim M.; Murphy, Suzanne P.

2012-01-01

Dietary supplement use is widespread among adults across races/ethnicities, yet reasons for use may vary across these groups. The SUpplement REporting (SURE) study quantified dietary supplement use and reasons for taking supplements in a multiethnic sample of adults who took at least one supplement. This study explored socio-demographic differences, including by race/ethnicity, associated with specific reasons/motivations for taking dietary supplements, including perceived importance of taking supplements relative to prescription medications. The study time period was March 2005 to August 2006. Participants (n=397) were older adults (age = 52–88 y) recruited from the Multiethnic Cohort Study in Hawaii and Los Angeles, with equal representation of males and females from six ethnic groups (white, Japanese-American, Native Hawaiian, African-American, US-born Latino, and foreign-born Latino). Subgroups of participants were compared by chi-square tests and logistic regression. The most common reasons for taking supplements were to maintain a healthy life, recommended by a health professional, and to prevent a disease/medical problem. A majority (76%) of participants reported that their dietary supplements were as important as prescription medications, with foreign-born Latinos and Japanese-Americans being most likely to state this belief. The relative importance of supplements was not associated with excessive use, but 27% of participants exceeded the upper limit for a nutrient. It is crucial for health professionals to better understand why individuals take supplements and the importance that they attach to their use. This information could lead to better monitoring and education efforts in order to prevent overuse of supplements and possible interactions with medications. PMID:22818730

Health Culture and Running: Non-Elite Runners' Understandings of Doping and Supplementation.

PubMed

Henning, April D

2015-01-01

Participants at the non-elite level of road running often take up the sport for purposes of health, as a way of taking responsibility for their own well-being. Often, these runners use dietary supplements as a way to improve health and to potentially enhance running performance. Supplements are distinct from banned performance enhancing drugs (PEDs), as they are legal and widely available, though very loosely regulated. Research demonstrates that the line between supplements and banned PEDs is increasingly blurry as cases of cross-contaminated and mislabeled supplements continue to be found. Such products may pose health risks to unsuspecting consumers. Despite anti-doping agencies' warnings to elite runners about these risks, non-elite runners are rarely told by any sport or anti-doping body to be wary of supplements. They are, however, inundated with media coverage of doping scandals usually involving only a few of the substances banned in sport. In short, these runners are often left to navigate supplement use on their own and many conflate supplement availability with safety. This article explores these routine dietary supplement practices among non-elite runners. Drawing from interviews with 28 non-elite runners in New York City, I discuss the perceptions and understandings of doping and dietary supplement use within the context of health culture. Interview data reveal that the social acceptance of dietary supplements and their widespread use among the broader public reinforce the notion among non-elite runners that such products are objectively safe and healthy. I argue that based on their assumptions of supplement safety, non-elite runners view dietary supplements as distinctly different from PEDs and that this difference encourages their use as health and performance aids.

Health Culture and Running: Non-Elite Runners’ Understandings of Doping and Supplementation

PubMed Central

Henning, April D.

2016-01-01

Participants at the non-elite level of road running often take up the sport for purposes of health, as a way of taking responsibility for their own well-being. Often, these runners use dietary supplements as a way to improve health and to potentially enhance running performance. Supplements are distinct from banned performance enhancing drugs (PEDs), as they are legal and widely available, though very loosely regulated. Research demonstrates that the line between supplements and banned PEDs is increasingly blurry as cases of cross-contaminated and mislabeled supplements continue to be found. Such products may pose health risks to unsuspecting consumers. Despite anti-doping agencies’ warnings to elite runners about these risks, non-elite runners are rarely told by any sport or anti-doping body to be wary of supplements. They are, however, inundated with media coverage of doping scandals usually involving only a few of the substances banned in sport. In short, these runners are often left to navigate supplement use on their own and many conflate supplement availability with safety. This article explores these routine dietary supplement practices among non-elite runners. Drawing from interviews with 28 non-elite runners in New York City, I discuss the perceptions and understandings of doping and dietary supplement use within the context of health culture. Interview data reveal that the social acceptance of dietary supplements and their widespread use among the broader public reinforce the notion among non-elite runners that such products are objectively safe and healthy. I argue that based on their assumptions of supplement safety, non-elite runners view dietary supplements as distinctly different from PEDs and that this difference encourages their use as health and performance aids. PMID:28782003

Doxycycline Compliance at Bagram Air Field

DTIC Science & Technology

2014-05-01

doxycycline absorption. In 2008, the Institute of Medicine issued a report entitled ·’Use of Dietary Supplements by Military Personnel" that reported 34...absorption by tetracycline. Br J Clin Pharmacal. 1975 February; 2(1): 94- 96. 19. 0. M. e. Greenwood MRC, "Use of Dietary Supplements by Military...Personnel.Institute of Medicine (US) Committee on Dietary Supplement Use by Military Personnel," National Academies Press, Washington (DC), 2008. 20

Research highlights from the UIC/NIH Center for Botanical Dietary Supplements Research for Women’s Health: Black cohosh from the field to the clinic

PubMed Central

Farnsworth, Norman R; Mahady, Gail B.

2009-01-01

In 1999, the Department of Medicinal Chemistry and Pharmacognosy at the College of Pharmacy, University of Illinois (UIC) at Chicago was funded to establish a Botanical Dietary Supplements Research Center from the National Institutes of Health (NIH). The emphasis of the UIC/NIH Center for Botanical Dietary Supplements Research (CBDSR) is botanical dietary supplements (BDS) for women's health. Center’s research has focused on BDS that may improve women's health and quality of life, specifically in the areas of menopause, premenstrual syndrome, and persistent urinary tract infections. Center investigators have overcome many challenges associated with botanical dietary supplements research, including acquiring and identifying plant species for investigation, isolating and identifying active constituents, elucidating the mechanisms of action of these botanicals, and conducting phase I and phase II clinical studies. Black cohosh [Actaea racemosa L. (Ranunculaceae)] has been used as a model to illustrate the steps involved in taking a botanical dietary supplement from the field, all the way to clinical trials. Bioassays are described that were necessary to elucidate the pertinent biological studies of plant extracts and their mechanisms of action. The Center has used an innovative multidisciplinary approach to this type of research, and thus has been very successful in fulfilling its specific aims. PMID:20161501

Dietary Supplement of Large Yellow Tea Ameliorates Metabolic Syndrome and Attenuates Hepatic Steatosis in db/db Mice

PubMed Central

Teng, Yun; Li, Daxiang; Guruvaiah, Ponmari; Xu, Na; Xie, Zhongwen

2018-01-01

Yellow tea has been widely recognized for its health benefits. However, its effects and mechanism are largely unknown. The current study investigated the mechanism of dietary supplements of large yellow tea and its effects on metabolic syndrome and the hepatic steatosis in male db/db mice. Our data showed that dietary supplements of large yellow tea and water extract significantly reduced water intake and food consumption, lowered the serum total and low-density lipoprotein cholesterol and triglyceride levels, and significantly reduced blood glucose level and increased glucose tolerance in db/db mice when compared to untreated db/db mice. In addition, the dietary supplement of large yellow tea prevented the fatty liver formation and restored the normal hepatic structure of db/db mice. Furthermore, the dietary supplement of large yellow tea obviously reduced the lipid synthesis related to gene fatty acid synthase, the sterol regulatory element-binding transcription factor 1 and acetyl-CoA carboxylase α, as well as fatty acid synthase and sterol response element-binding protein 1 expression, while the lipid catabolic genes were not altered in the liver of db/db mice. This study substantiated that the dietary supplement of large yellow tea has potential as a food additive for ameliorating type 2 diabetes-associated symptoms. PMID:29329215

78 FR 39736 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug... information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' to OMB... collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary...

[Nutrition and dietary supplements in neurological diseases].

PubMed

Erbguth, F; Himmerich, H

2014-12-01

"Healthy" diets and supplements are widely used for prevention and disease modification in vascular, inflammatory and degenerative neurological diseases. Apart from a large number of cross-sectional and prospective cohort studies, there are only few interventional studies on individual dietary measures. A recent study confirmed the stroke preventive effect of a Mediterranean diet rich in olive oil and nuts; a ketogenic diet reduces seizure frequency in epilepsy. Supplementation of riboflavin, magnesium and coenzyme Q10 are probably effective in migraine prophylaxis. Creatine can improve muscle strength in muscular dystrophy and myositis. There is insufficient evidence to recommend any of the many dietary supplements, such as vitamins, omega-3 fatty acids and other substances for the prevention or improvement of all other neurological diseases. This review critically evaluates the present data on the role of nutrition and dietary supplements in neurological diseases.

Threonine supplementation reduces dietary protein and improves lipid metabolism in Pekin ducks.

PubMed

Jiang, Y; Tang, J; Xie, M; Wen, Z G; Qiao, S Y; Hou, S S

2017-12-01

1. This study was conducted to investigate the efficiency of threonine (Thr) supplementation on reducing dietary crude protein (CP) content and the effects of Thr on lipid metabolism in Pekin ducks. The effects of dietary CP concentration (160, 190 and 220 g/kg) and Thr supplemental concentration (0, 0.7, 1.4, 2.1 and 2.8 g/kg) on growth performance, carcass, liver lipid and plasma profiles were determined in Pekin ducks from 1-21 d of age. 2. A total of 720-d-old male Pekin ducks were randomly allotted to 1 of 15 dietary treatments with 6 replicate cages of 8 birds per cage for each treatment according to average body weight. 3. Dietary Thr supplementation improved growth performance and breast muscle percentage at all CP diets, and ducks fed Thr-supplemented diets had higher plasma concentrations of some plasma amino acids. Thr supplementation reduced the concentrations of total lipid, triglyceride, cholesterol in liver, and plasma low density lipoprotein cholesterin concentration at 160 and 190 g/kg CP, whereas it increased triglyceride concentration at 160 g/kg CP. 4. Thr requirements based on quadratic broken-line model estimation were 6.6 and 7.0 g/kg for optimal average daily gain (ADG), and 6.7 and 7.3 g/kg for breast muscle percentage of Pekin ducks from 1-21 d of age at 190 and 220 g/kg CP, respectively. The dietary Thr requirements and estimated ADG (55.18 vs. 55.86 g/d/bird) and breast muscle percentage (2.79% vs. 2.75%) of Pekin ducks did not differ between 190 and 220 g/kg CP according to the t-test results. 5. Dietary CP level could be reduced to 190 g/kg in Pekin ducks from 1-21 d of age with Thr supplementation to balance dietary amino acids, and Thr supplementation prevented excess liver lipid deposition in this instance.

Examination of Vitamin Intakes among US Adults by Dietary Supplement Use

PubMed Central

Bailey, Regan Lucas; Fulgoni, Victor L.; Keast, Debra R.; Dwyer, Johanna T.

2013-01-01

Background More than half of US adults use dietary supplements. Some reports suggest that supplement users have higher vitamin intakes from foods than nonusers, but this observation has not been examined using nationally representative survey data. Objective The purpose of this analysis was to examine vitamin intakes from foods by supplement use and how dietary supplements contribute to meeting or exceeding the Dietary Reference Intakes for selected vitamins using data from the National Health and Nutrition Examination Survey among adults (aged ≥19 years) in 2003–2006 (n=8,860). Results Among male users, mean intakes of folate and vitamins A, E, and K from food sources were significantly higher than among nonusers. Among women, mean intakes of folate and vitamins A, C, D, and E from foods were higher among users than nonusers. Total intakes (food and supplements) were higher for every vitamin we examined among users than the dietary vitamin intakes of nonusers. Supplement use helped lower the prevalence of intakes below the Estimated Average Requirement for every vitamin we examined, but for folic acid and vitamins A, B-6, and C, supplement use increased the likelihood of intakes above the Tolerable Upper Intake Level. Conclusions Supplement use was associated with higher mean intakes of some vitamins from foods among users than nonusers, but it was not associated with the prevalence of intakes less than the Estimated Average Requirement from foods. Those who do not use vitamin supplements had significantly higher prevalence of inadequate vitamin intakes; however, the use of supplements can contribute to excess intake for some vitamins. PMID:22709770

The role of gangliosides in brain development and the potential benefits of perinatal supplementation.

PubMed

Ryan, Jennifer M; Rice, Gregory E; Mitchell, Murray D

2013-11-01

The maternal diet provides critical nutrients that can influence fetal and infant brain development and function. This review highlights the potential benefits of maternal dietary ganglioside supplementation on fetal and infant brain development. English-language systematic reviews, preclinical studies, and clinical studies were obtained through searches on PubMed. Reports were selected if they included benefits and harms of maternal ganglioside supplementation during pregnancy or ganglioside-supplemented formula after pregnancy. The potential benefits of ganglioside supplementation were explored by investigating the following: (1) their role in neural development, (2) their therapeutic use in neural injury and disease, (3) their presence in human breast milk, and (4) their use as a dietary supplement during or after pregnancy. Preclinical studies indicate that ganglioside supplementation at high doses (1% of total dietary intake) can significantly increase cognitive development and body weight when given prenatally. However, lower ganglioside supplementation doses have no beneficial cognitive effects, even when given throughout pregnancy and lactation. In human clinical trials, infants given formula supplemented with gangliosides showed increased cognitive development and an increase in ganglioside content. Ganglioside supplementation may promote brain development and function in offspring when administered at the optimum dosage. We propose that prenatal maternal dietary supplementation with gangliosides throughout pregnancy may promote greater long-term effects on brain development and function. Before this concept can be encouraged in preconception clinics, future research and clinical trials are needed to confirm the ability of dietary gangliosides to improve cognitive development, but available results already encourage this area of research. © 2013.

Current dietary supplement use of Australian military veterans of Middle East operations.

PubMed

van der Pols, Jolieke C; Kanesarajah, Jeeva; Bell, Alison; Lui, Chi-Wai

2017-12-01

To assess patterns and levels of dietary supplement use among Australian Defence Forces, previously deployed to the Middle East Area of Operations. A cross-sectional study. Participants of a large survey self-completed questions about dietary supplement use, health status, personal and job-related characteristics, and lifestyle factors. Frequency of current use of supplements was assessed in three categories (bodybuilding, energy and weight loss). Middle East Area of Operations post-deployment health survey. Current and ex-serving Australian Defence Force personnel (n 14 032) who deployed to the Middle East between 2001 and 2009. Bodybuilding supplements were used by 17·5 % of participants, energy supplements by 24·5 % and weight-loss supplements by 7·6 %. Overall, 32·3 % of participants used any of these supplements. Bodybuilding and energy supplements were more often used by men, younger persons and those in the Army, while weight-loss supplements were more commonly used by women and Navy personnel. Supplements in all three categories were more commonly used by persons in lower ranks, active service and combat roles. Users of bodybuilding supplements had healthier lifestyles and better health status, while users of energy and weight-loss supplements had less healthy lifestyles and poorer mental and physical health status. Overall, 11·7 % of participants used supplements containing caffeine and 3·6 % used a creatine-containing product. Use of dietary supplements among Australian Defence Force personnel is common, and patterned by lifestyle factors and health status.

Dietary supplementation of organic selenium could improve performance, antibody response, and yolk oxidative stability in laying hens fed on diets containing oxidized fat.

PubMed

Laika, M; Jahanian, R

2015-06-01

The present study was carried out to investigate the effect of dietary supplementation of organic selenium (Se) on performance, egg quality indices, and yolk oxidative stability in laying hens fed diets with different fat sources. A total of 270 Hy-line W-36 Leghorn hens of 47 weeks of age were randomly distributed into the 5 replicate cages of 9 dietary treatments. Experimental diets consisted of a 3 × 3 factorial arrangement of treatments with three different fat sources (soybean oil, SO; yellow grease, YG; and palm fat powder, PFP) and three different levels of supplemental Se (0, 0.2, and 0.4 mg/kg of diet) as supplied by zinc-L-selenomethionine (ZnSeMet) complex, which fed during a 77-day feeding trial including 7 days for adaptation and 70 days as the main recording period. Results showed that the highest (P < 0.05) egg weights assigned to the hens fed on SO-supplemented diets. Hen-day egg production was affected by both dietary fat source (P < 0.01) and Se level (P < 0.05) throughout the trial period. Regardless of dietary fat source, dietary supplementation of ZnSeMet improved (P < 0.05) egg mass during all trial periods. Moreover, the significant (P < 0.05) fat  source× Se interactions were observed for egg mass, so that dietary supplementation with 0.4 mg/kg Se was more effective in diets supplemented with YG. Although feed intake was not affected by experimental diets during the first 35-day period, dietary inclusion of PFP reduced feed intake during both second 35-day (P < 0.01) and entire trial period (P < 0.05). The best (P < 0.01) feed conversion ratio during the first 35-day period was assigned to the birds fed on SO-diets, followed by those fed YG-diets. Dietary supplementation of ZnSeMet improved (P < 0.05) feed efficiency during the first 35-day period. Supplementation of ZnSeMet into the diets increased yolk index, with more impact in hens fed on YG-diets. The highest concentration of yolk malondialdehyde was observed in YG-fed groups, and ZnSeMet supplementation of diets decreased (P < 0.05) yolk malondialdehyde. The highest (P<0.01) glutathione peroxidase activity was observed for hens fed on diets supplemented by YG, followed by those on SO-diets. Although different fat sources had no effect on antibody titer against Newcastle disease virus, supplemental ZnSeMet improved (P < 0.05) antibody response. The present findings indicate that dietary supplementation of ZnSeMet could improve performance parameters and egg oxidative stability in laying hens, with the highest impact in diets containing oxidized (high peroxide values) fat sources.

Response of growing goslings to dietary supplementation with methionine and betaine.

PubMed

Yang, Z; Wang, Z Y; Yang, H M; Zhao, F Z; Kong, L L

2016-12-01

An experiment with a 2 × 3 factorial design with two concentrations of dietary betaine (0 and 600 mg/kg) and three dietary concentrations of methionine (0, 600 and 1200 mg/kg) was conducted using goslings to estimate growth, nutrient utilisation and digestibility of amino acids from 21 to 70 d of age. Three hundred geese were randomised at 18 d of age into 6 groups with 5 replicates per treatment and 10 geese per replicate. Increasing dietary concentrations of methionine gave a linear increase in body weight and average daily gain. The coefficient of crude fat retention increased as dietary methionine increased and there was a significant non-linear response to increasing dietary methionine. Similarly, increasing supplemental methionine gave linear increases in the digestibility of methionine and cysteine. The results of this study indicated that optimal dietary supplementation of methionine could increase growth performance and methionine and cysteine utilisation in growing goslings. Betaine supplementation had no apparent sparing effect on methionine needs for growth performance, but did improve the apparent cysteine digestibility.

Selenium, Chromium, and Vitamin D: What Dietitians Need to Know Regarding Dietary Supplements

USDA-ARS?s Scientific Manuscript database

Accurate nutrient data for dietary supplement composition are essential for determining supplements’ contribution to total dietary intake. To plan a nationwide adult multivitamin/mineral (MVM) study, the USDA Nutrient Data Laboratory (NDL) obtained prevalence information for the most common labeled...

Evidence for Dietary Fibre Modification in the Recovery and Prevention of Reoccurrence of Acute, Uncomplicated Diverticulitis: A Systematic Literature Review

PubMed Central

Dahl, Camilla; Crichton, Megan; Jenkins, Julie; Nucera, Romina; Mahoney, Sophie; Marx, Wolfgang

2018-01-01

In practice, nutrition recommendations vary widely for inpatient and discharge management of acute, uncomplicated diverticulitis. This systematic review aims to review the evidence and develop recommendations for dietary fibre modifications, either alone or alongside probiotics or antibiotics, versus any comparator in adults in any setting with or recently recovered from acute, uncomplicated diverticulitis. Intervention and observational studies in any language were located using four databases until March 2017. The Cochrane Risk of Bias tool and GRADE were used to evaluate the overall quality of the evidence and to develop recommendations. Eight studies were included. There was “very low” quality evidence for comparing a liberalised and restricted fibre diet for inpatient management to improve hospital length of stay, recovery, gastrointestinal symptoms and reoccurrence. There was “very low” quality of evidence for using a high dietary fibre diet as opposed to a standard or low dietary fibre diet following resolution of an acute episode, to improve reoccurrence and gastrointestinal symptoms. The results of this systematic review and GRADE assessment conditionally recommend the use of liberalised diets as opposed to dietary restrictions for adults with acute, uncomplicated diverticulitis. It also strongly recommends a high dietary fibre diet aligning with dietary guidelines, with or without dietary fibre supplementation, after the acute episode has resolved. PMID:29382074

Knowledge and use of dietary supplements by students of College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria

PubMed Central

Aina, Bolajoko A.; Ojedokun, Oluwayemisi A.

2014-01-01

Rationale: Nutritional supplements are preparations intended to supplement the diet and provide nutrients. They include vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet. Many health professionals including dietitians, physicians and pharmacists are supplement users. Objectives: The objectives of the present study were to determine knowledge and use of dietary supplements among students of College of Medicine, University of Lagos who are potential health professionals. Methodology: A self-administered questionnaire with a mix of open and close ended questions was employed to collect data in this study. It was distributed to 300 students that were in their final year in various departments of the college. Findings: Response rate was 89%. About 86% of the students have used dietary supplement before while half of them (50%) have used it in the past 12 months. The common types of dietary supplements used in the past 12 months are the vitamins. The reasons for use by the students were good health, poor diet, to boost immunity, weight gain and doctor's prescription. Most of the students were occasional and once in a while users. Conclusions: Majority of the students were aware of dietary supplement use and most of them were occasional users. PMID:25031497

US Dietary Supplement Labeling Rules and the Possibility of Medical Cost Reduction.

PubMed

Amagase, Harunobu

2015-01-01

US dietary supplements classified as foods are regulated under the Dietary Supplement Health and Education Act (DSHEA) and other rules. After the DSHEA established in 1994, the supplement market grew by about 4 times and reached $32 billion as of 2012. One of the major reasons for this market expansion is that consumers can recognize functions of the supplements by the structure/function (S/F) claims. S/F claims must not be false or misleading, and must be based upon reliable scientific evidence, especially clinical studies. At the same time, disclaimers must be shown on the package, which are "These statements have not been evaluated by the Food and Drug Administration (FDA). These products are not intended to diagnose, treat, cure or prevent any disease." Both the FDA and Federal Trade Commission (FTC) are responsible for label claims and advertisement of dietary supplements. S/F claims are not medical claims, but these may have impact on people's mindset to be healthier. Recent research shows utilizing dietary supplements in 4 major areas with 10 popular ingredients could hypothetically reduce medical costs by over $50 billion in the US in the period of 2013-2020. Predicted fewer health problems and reduced medical cost information will further increase awareness of supplement usage and thus may raise quality of life. These may reduce the medical cost significantly, if the products are used appropriately with sufficient consumer education.

Dietary supplements for aquatic sports.

PubMed

Derave, Wim; Tipton, Kevin D

2014-08-01

Many athletes use dietary supplements, with use more prevalent among those competing at the highest level. Supplements are often self-prescribed, and their use is likely to be based on an inadequate understanding of the issues at stake. Supplementation with essential micronutrients may be useful when a diagnosed deficiency cannot be promptly and effectively corrected with food-based dietary solutions. When used in high doses, some supplements may do more harm than good: Iron supplementation, for example, is potentially harmful. There is good evidence from laboratory studies and some evidence from field studies to support health or performance benefits from appropriate use of a few supplements. The available evidence from studies of aquatic sports is small and is often contradictory. Evidence from elite performers is almost entirely absent, but some athletes may benefit from informed use of creatine, caffeine, and buffering agents. Poor quality assurance in some parts of the dietary supplements industry raises concerns about the safety of some products. Some do not contain the active ingredients listed on the label, and some contain toxic substances, including prescription drugs, that can cause health problems. Some supplements contain compounds that will cause an athlete to fail a doping test. Supplement quality assurance programs can reduce, but not entirely eliminate, this risk.

Issues in Nutrition: Dietary Supplements.

PubMed

Thompson, Margaret E; Noel, Mary Barth

2017-01-01

The majority of American adults report use of one or more dietary supplements every day or occasionally. The Dietary Supplement Health and Education Act of 1994 defines dietary supplements and regulates their manufacture and distribution. One of the most commonly used supplements is vitamin D. Measurement of serum levels of vitamin D must be undertaken with the caveats that different laboratories define normal levels differently, and that there is rarely a clinical correlation with the actual level. Patients should understand that supplements should not be used to excess, as there are toxicities and other adverse effects associated with most of them. There currently is considerable research being performed on probiotics and how the gut microbiome affects health and disease states. Protein supplements may be useful in reducing mortality rates in elderly patients but they do not appear to increase quality of life. If used, protein supplements should contain essential amino acids. Casein and whey supplements, derived from dairy sources, help transport essential amino acids to tissues. Although there have been many studies investigating the role of vitamin supplements in disease prevention, there have been few conclusive positive results. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Vitamin Supplement Use and Risk for Breast Cancer: The Shanghai Breast Cancer Study.

PubMed Central

Dorjgochoo, Tsogzolmaa; Shrubsole, Martha J.; Shu, Xiao Ou; Lu, Wei; Ruan, Zhixian; Zhen, Ying; Dai, Qi; Gu, Kai; Gao, Yu-Tang; Zheng, Wei

2008-01-01

Objective: The influence of vitamin supplements on risk for breast cancer is unclear. Also the interactive effects of vitamins from dietary and supplemental sources are unknown. This study investigated the association between self-reported vitamin supplement use (A, B, C, E and multivitamin) and breast cancer among urban Chinese women. It also examined the combined effect of vitamin supplements in relation to particular dietary vitamin intakes on breast cancer risk. Methods: Study subjects were identified from The Shanghai Breast Cancer Study (SBCS) and was a population-based case-control study conducted in Shanghai in 1996-1998 (Phase I) and 2002-2004 (Phase II). Participants were aged 25 to 64 and 20 to 70 years for phase I and for phase II, respectively. The analyses included 3,454 incident breast cancer cases and 3,474 controls. Unconditional logistic regression models were used to determine adjusted odds ratios (ORs) for breast cancer risk associated with vitamin supplement use. Results: Overall, the breast cancer risk was not related to intakes of any vitamin supplement. However, an approximately 20% reduction in breast cancer risk was observed with use of vitamin E supplement among women with low-dietary vitamin E intake (OR=0.8; 95% confidence interval (CI), 0.6-0.9) with a significant does-response inverse association (P trend =0.01 for duration). Modest risk reduction was observed among vitamin B supplement users with low dietary intake of the same vitamin (OR=0.9; 95% CI, 0.6-1.0). However, vitamin B supplement was adversely associated with breast cancer risk among those with high dietary vitamin B intake with a significant dose-response effect (P trend =0.04 for duration). Conclusions: This study suggests that vitamins E and B supplement may confer a prevention of breast cancer among women who have low dietary intake of those vitamins. PMID:17917808

Multivitamin/Mineral Supplements

MedlinePlus

... of folic acid from fortified foods and/or dietary supplements to reduce the risk of birth defects of the brain and spine ... of vitamin B12 from fortified foods and/or dietary supplements because they ... MVM is unlikely to pose any risks to health. But if you consume fortified foods ...