A Review of the Efficacy, Safety, and Clinical Implications of Naturally Derived Dietary Supplements for Dyslipidemia.

PubMed

Thaipitakwong, Thanchanit; Aramwit, Pornanong

2017-02-01

Dyslipidemia is recognized as a major cause of cardiovascular disease. A number of evidence-based guidelines recommend conventional synthetic drugs as standard therapy for dyslipidemia in clinical practice. However, antihyperlipidemic drugs have some serious side effects. Naturally derived dietary supplements are becoming attractive as an alternative strategy because of their high efficacy and safety, as supported by numerous data. Moreover, they could be considered an initial treatment for dyslipidemia. The aims of this literature review were to demonstrate the efficacy, safety, and clinical implications of dietary supplements for treating dyslipidemia. We reviewed the literature, including data from in vitro, in vivo, and human studies, and clinical guideline recommendations. We classified dietary supplements by their proposed mechanisms of action on lipid metabolism and also collected daily dosage recommendations, interactions with concurrent drugs and/or foods, dosage forms, and examples of commercially available products. Various types of naturally derived dietary supplements exhibit lipid-improving properties. Efficacy and safety are acceptable; however, their use in clinical practice will require further well-designed investigations and the support of scientific data.

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

Caffeine-based food supplements and beverages: Trends of consumption for performance purposes and safety concerns.

PubMed

Bessada, Sílvia M F; Alves, Rita C; Oliveira, M Beatriz P P

2018-07-01

Nowadays, daily food supplementation regarding the improvement of physical and mental performance is a growing trend in sport practitioners, young students and active people. Food supplements are foodstuffs, labeled under food law and not obliged to safety assessments before their commercialization. Several products are commercialized claiming ergogenic effects as marketing strategies. Caffeine is often one of their main ingredients, as it increases both physical performance and concentration. This manuscript presents a general overview of the current caffeine-based food supplements and energy drinks available in the Portuguese market, as well as the consuming trends regarding their ergogenic effects, performance purposes, and active ingredients. Product claims, recommended daily intakes, caffeine pharmacology, and safety concerns aspects are also discussed aspects. Copyright © 2018 Elsevier Ltd. All rights reserved.

76 FR 14641 - Defense Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS Case 2010-D022... contract clause that clearly identifies any items being purchased that are critical safety items so that.... SUPPLEMENTARY INFORMATION: I. Background This DFARS case was initiated at the request of the Defense Contract...

Mission impossible? Regulatory and enforcement issues to ensure safety of dietary supplements.

PubMed

Petroczi, A; Taylor, G; Naughton, D P

2011-02-01

Dietary supplements are widely used across all ages and user groups and constitute a considerable business sector in most developed countries. Hazards relating to concentration, composition, individual contaminants and supplement interactions present an increasing public health concern. The aim of this paper is to review the literature for reported supplement contaminations (occurs in ca 25% of supplements, with anabolic steroids being the most common) and complement these findings with notifications logged in the EU's Rapid Alert System for Food and Feed (RASFF) through imports or market surveillance, typically logged for poor quality control issues. Notifications in the RASFF have steadily increased by sixfold for supplements in the past 7 years with the USA and China being the major transgressors. Finland and Italy lead in detections, mainly notifying unpermitted substances and contaminants in sexual-enhancing or weight-loss supplements. This paper highlights the paucity of enforcement. Regulating supplements as a foodstuff and not a medicine, coupled with the fact that a significant proportion of the supplement market is distributed via the Internet (hence absent from routine border control and surveillance), make ensuring and enforcing safety a very challenging task. The need for better quality control, compliance and public awareness is evident. Copyright © 2010 Elsevier Ltd. All rights reserved.

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

PubMed Central

Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

2015-01-01

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states. PMID:25569274

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.

PubMed

Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

2015-01-01

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.

PubMed

Cohen, Pieter A; Bloszies, Clayton; Yee, Caleb; Gerona, Roy

2016-01-01

The amphetamine isomer β-methylphenylethylamine (BMPEA) was first synthesized in the early 1930s, but its efficacy and safety in humans has not been studied. Recently, the United States Food and Drug Administration (FDA) detected BMPEA in dietary supplements labelled as containing Acacia rigidula. Over a year after the FDA reported its findings, we analyzed Acacia rigidula dietary supplements to determine if BMPEA had been removed. Supplements were analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry. Diluted methanolic extract from each supplement was run three times and each data set obtained was analyzed using Agilent MassHunter Qualitative Analysis. The presence of BMPEA was confirmed by accurate mass, retention time and mass spectra match against a reference standard. Quantification of BMPEA was determined using an eight-point calibration curve of spiked standard to a matrix blank. Twenty-one brands of Acacia rigidula supplements were analyzed. More than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA. The stimulant was present at quantities such that consumers following recommended maximum daily servings would consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Use and safety perceptions regarding herbal supplements: a study of older persons in southeast Idaho.

PubMed

Snyder, Frank J; Dundas, Mary L; Kirkpatrick, Carol; Neill, Karen S

2009-01-01

Herbal supplements (HS) are used by older persons and are often perceived as safe, although there is limited research that examines why this perception exists. A questionnaire was developed and pilot tested to investigate the use and perceived safety of HS among a convenience sample of 112 adults aged 60 to 92 in southeast Idaho. Fifty-five percent of the participants (n = 62) reported using HS in the past. Ninety-five percent (n = 59) of those using HS and 75% (n = 37) of nonusers reported they believed most or some HS were safe. Perception of herbal supplement safety was greatly influenced by family and friends, and HS users had a greater perception of safety than nonusers (p < or = .001). The top reasons for perceived safety given by HS users were that HS: (1) can be purchased without a prescription, (2) can be purchased in many locations, and (3) are natural.

Clinical safety assessment of oral higenamine supplementation in healthy, young men.

PubMed

Bloomer, R J; Schriefer, J M; Gunnels, T A

2015-10-01

Higenamine, an herbal agent also known as norcoclaurine, is thought to stimulate β-androgenic receptors and possess lipolytic activity. It is currently making its way into the dietary supplement market. To our knowledge, no studies have been conducted to determine the safety profile of oral higenamine when used alone and in conjunction with other commonly used lipolytic agents. Forty-eight men were assigned to ingest either a placebo, higenamine, caffeine, or higenamine + caffeine + yohimbe bark extract daily for a period of 8 weeks. Before and after 4 and 8 weeks of supplementation, the following variables were measured: resting respiratory rate, heart rate, blood pressure, urinalysis, complete blood count, metabolic panel, liver enzyme activity, and lipid panel. No interaction effects were noted for any variable (p > 0.05), with no changes of statistical significance occurring across time for any of the four conditions (p > 0.05). This is the first study to determine the safety profile of oral higenamine intake in human subjects. Our data indicate that 8 weeks of daily higenamine supplementation, either alone or in conjunction with caffeine and yohimbe bark extract, does not result in a statistically significant change in any of the measured outcome variables. Additional studies, inclusive of a larger sample size, are needed to extend these initial findings. © The Author(s) 2015.

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children.

PubMed

Tan, Tina P; Ba, Zhaoyong; Sanders, Mary E; D'Amico, Frank J; Roberts, Robert F; Smith, Keisha H; Merenstein, Daniel J

2017-02-01

Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12-supplemented yogurt on the gut microbiota of the children. Sixty children ages 1 to 5 years were randomly assigned to consume 4 ounces of either BB-12-supplemented yogurt or nonsupplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. A total of 186 nonserious adverse events were reported, with no significant differences between the control and BB-12 groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. BB-12-supplemented yogurt is safe and well-tolerated when consumed by healthy children. The present study will form the basis for future randomized clinical trials investigating the potential effects of BB-12-supplemented yogurt in different disease states.

Seventy day safety assessment of an orally ingested, l-glutamine-containing oat and yeast supplement for horses.

PubMed

Lindinger, Michael I; Anderson, Scott C

2014-10-01

We describe a safety assessment of an oral supplement designed to nutritionally support the gastrointestinal system of horses. The supplement comprised a mixture of essential (l-threonine) and conditionally essential (l-glutamine) amino acids, polar lipids, oat bran rich in beta glucans and yeast extract. Young (1-2years) horses of both sexes were allocated to control (n=7) and treatment groups (n=7) and studied for 9weeks. Horses in the treatment group received the supplement daily for 8weeks. After 8weeks of supplementation, horses were studied for one additional week. Outcome measures included body mass, weight gain, results of clinical examination, hematology and plasma chemistry. There were no adverse events associated with supplementation and horses in both groups showed normal weight gain, clinical signs, hematology and chemistry. l-Glutamine, which is not yet listed as GRAS, was considered with respect to its potential for nutritional support and safety when ingested orally. It is concluded that this oral supplement, when ingested by horses at twice the recommended daily level, was safe and does not pose a health risk when used in accordance with good feeding practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

PubMed

Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

2016-01-01

It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt in healthy children

PubMed Central

Tan, Tina P.; Ba, Zhaoyong; Sanders, Mary Ellen; D’Amico, Frank J.; Roberts, Robert F.; Smith, Keisha Herbin; Merenstein, Daniel J.

2016-01-01

Objectives Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration (FDA) has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12® (BB-12®)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12®-supplemented yogurt on the gut microbiota of the children. Methods Sixty children aged 1–5 years were randomly assigned to consume four ounces of either BB-12®-supplemented yogurt or non-supplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. Results A total of 186 non-serious adverse events were reported, with no significant differences between the control and BB-12® groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. Conclusions BB-12®-supplemented yogurt is safe and well-tolerated when consumed by healthy children. This study will form the basis for future randomized clinical trials investigating the potential effects of BB-12®-supplemented yogurt in different disease states. PMID:28114246

Assessment of health claims, content, and safety of herbal supplements containing Ginkgo biloba

PubMed Central

Fransen, Heidi P.; Pelgrom, Sylvia M.G.J.; Stewart-Knox, Barbara; de Kaste, Dries; Verhagen, Hans

2010-01-01

Background European Regulation 1924/2006 states that all health claims made on foods need to be substantiated scientifically. Objective To apply the PASSCLAIM criteria for the scientific substantiation of health claims on foods to herbal supplements containing Ginkgo biloba. Evaluation of three selected claimed health effects for G. biloba (improvement of blood circulation, improvement of symptoms of old age, and improvement of memory) was achieved through review of publicly available scientific data. A total of 35 human intervention studies were evaluated. Commercially available products claimed to contain mainly G. biloba (N=29) were randomly sampled in the Netherlands and analyzed for their content on ginkgo extract. Also, a toxicological risk assessment was performed. Results The three selected health claims investigated could not be substantiated. This was mainly because of a lack of data from studies in healthy volunteers. In most studies results performed with a 24% standardized G. biloba extract were described. However, our chemical analysis showed that 25 of the 29 sampled products did not contain the required minimum 24% standardized extract. Moreover, in most preparations the content of substances typical for G. biloba did not conform to what was declared on the label. Since toxicity data for G. biloba are very limited, a safety limit could not be established. Conclusions Evidence is lacking for three health claims of herbal products with G. biloba. Neither safety nor efficacy can be guaranteed at the recommended daily dose. The multidisciplinary approach described in this paper provides good insight into issues that are relevant for the evaluation of health claims for herbal food supplements. PMID:20927202

[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".

Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

PubMed

Vujić, Mario; Pollak, Lea

2015-12-01

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

Effects of daily iron supplementation in primary-school–aged children: systematic review and meta-analysis of randomized controlled trials

PubMed Central

Low, Michael; Farrell, Ann; Biggs, Beverley-Ann; Pasricha, Sant-Rayn

2013-01-01

Background: Anemia is an important public health and clinical problem. Observational studies have linked iron deficiency and anemia in children with many poor outcomes, including impaired cognitive development; however, iron supplementation, a widely used preventive and therapeutic strategy, is associated with adverse effects. Primary-school–aged children are at a critical stage in intellectual development, and optimization of their cognitive performance could have long-lasting individual and population benefits. In this study, we summarize the evidence for the benefits and safety of daily iron supplementation in primary-school–aged children. Methods: We searched electronic databases (including MEDLINE and Embase) and other sources (July 2013) for randomized and quasi-randomized controlled trials involving daily iron supplementation in children aged 5–12 years. We combined the data using random effects meta-analysis. Results: We identified 16 501 studies; of these, we evaluated 76 full-text papers and included 32 studies including 7089 children. Of the included studies, 31 were conducted in low- or middle-income settings. Iron supplementation improved global cognitive scores (standardized mean difference 0.50, 95% confidence interval [CI] 0.11 to 0.90, p = 0.01), intelligence quotient among anemic children (mean difference 4.55, 95% CI 0.16 to 8.94, p = 0.04) and measures of attention and concentration. Iron supplementation also improved age-adjusted height among all children and age-adjusted weight among anemic children. Iron supplementation reduced the risk of anemia by 50% and the risk of iron deficiency by 79%. Adherence in the trial settings was generally high. Safety data were limited. Interpretation: Our analysis suggests that iron supplementation safely improves hematologic and nonhematologic outcomes among primary-school–aged children in low- or middle-income settings and is well-tolerated. PMID:24130243

Implementing a "quality by design" approach to assure the safety and integrity of botanical dietary supplements.

PubMed

Khan, Ikhlas A; Smillie, Troy

2012-09-28

Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined.

Green tea polyphenols supplementation and Tai Chi exercise for postmenopausal osteopenic women: safety and quality of life report

PubMed Central

2010-01-01

Background Evidence suggests that both green tea polyphenols (GTP) and Tai Chi (TC) exercise may benefit bone health in osteopenic women. However, their safety in this population has never been systematically investigated. In particular, there have been hepatotoxicity concerns related to green tea extract. This study was to evaluate the safety of 24 weeks of GTP supplementation combined with TC exercise in postmenopausal osteopenic women, along with effects on quality of life in this population. Methods 171 postmenopausal women with osteopenia were randomly assigned to 4 treatment arms for 24 weeks: (1) Placebo (500 mg starch/day), (2) GTP (500 mg GTP/day), (3) Placebo + TC (placebo plus TC training at 60 min/session, 3 sessions/week), and (4) GTP + TC (GTP plus TC training). Safety was examined by assessing liver enzymes (aspartate aminotransferase, alanine aminotransferase), alkaline phosphatase, and total bilirubin at baseline and every 4 weeks. Kidney function (urea nitrogen and creatinine), calcium, and inorganic phosphorus were also assessed at the same times. Qualify of life using SF-36 questionnaire was evaluated at baseline, 12, and 24 weeks. A mixed model of repeated measures ANOVA was applied for analysis. Results 150 subjects completed the study (12% attrition rate). The compliance rates for study agents and TC exercise were 89% and 83%, respectively. Neither GTP supplementation nor TC exercise affected liver or kidney function parameters throughout the study. No adverse event due to study treatment was reported by the participants. TC exercise significantly improved the scores for role-emotional and mental health of subjects, while no effect on quality of life was observed due to GTP supplementation. Conclusions GTP at a dose of 500 mg/day and/or TC exercise at 3 hr/week for 24 weeks appear to be safe in postmenopausal osteopenic women, particularly in terms of liver and kidney functions. TC exercise for 24 weeks (3 hr/wk) significantly improved

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.

Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus-Infected Children and Young Adults.

PubMed

Schall, Joan I; Hediger, Mary L; Zemel, Babette S; Rutstein, Richard M; Stallings, Virginia A

2016-09-01

There is uncertainty whether long-term daily dosing with vitamin D3 (cholecalciferol) supplementation (vitD3) above the 4000-IU/d dietary reference intake upper tolerable limit in children and adults is safe. As part of a randomized placebo-controlled trial, we determined if supplementation with 7000-IU/d vitD3 for 12 months in human immunodeficiency virus (HIV)-Infected subjects was safe and/or associated with metabolic outcomes. A total of 58 HIV-infected subjects-aged 9-24.9 years and stratified by mode of HIV acquisition (perinatal or behavioral)-were recruited, randomized to 7000-IU/d vitD3 or placebo, and followed at 3, 6, and 12 months with physical examinations, blood and urine sampling for measures of 25(OH)D (serum 25-hydroxyvitamin D), metabolic status, safety measures, and HIV immune status. Safety was defined by a low incidence (<5%) of the study-defined serious adverse events-that is, elevated serum calcium plus 25(OH)D >160 ng/mL-and no changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status. Randomization groups did not differ in demographic characteristics, vitamin D status, or HIV disease status at baseline. Over the 12 months, serum 25(OH)D increased with supplementation. No subject experienced a serious adverse safety event; none had 25(OH)D >80 ng/mL at any time. There were no clinically significant changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status. Safety of daily 7000-IU vitD3 supplementation in children and young adults with HIV was comprehensively monitored over 12 months. High-dose daily vitD3 supplementation was efficacious in improving vitamin D status, and there were no safety events. © 2015 American Society for Parenteral and Enteral Nutrition.

Safety assessment of green tea based beverages and dried green tea extracts as nutritional supplements.

PubMed

Dekant, Wolfgang; Fujii, Kenkichi; Shibata, Eiichiro; Morita, Osamu; Shimotoyodome, Akira

2017-08-05

The safety of green tea infusions and green tea extract (GTE)-based products is reviewed regarding catechins. Epigallocatechin 3-gallate (EGCG), the major catechin present in green tea, is suspected of being responsible for liver toxicity reported in humans consuming food supplements. Intake of EGCG with green tea infusions and GTE-based beverages is up to about 450mg EGCG/person/day in Europe and higher in Asia. Consumption of green tea is not associated with liver damage in humans, and green tea infusion and GTE-based beverages are considered safe in the range of historical uses. In animal studies, EGCG's potency for liver effects is highly dependent on conditions of administration. Use of NOAELs from bolus administration to derive a tolerable upper intake level applying the margin of safety concept results in acceptable EGCG-doses lower than those from one cup of green tea. NOAELs from toxicity studies applying EGCG with diet/split of the daily dose are a better point of departure for risk characterization. In clinical intervention studies, liver effects were not observed after intakes below 600mg EGCG/person/day. Thus, a tolerable upper intake level of 300mg EGCG/person/day is proposed for food supplements; this gives a twofold safety margin to clinical studies that did not report liver effects and a margin of safety of 100 to the NOAELs in animal studies with dietary administration of green tea catechins. Copyright © 2017 Elsevier B.V. All rights reserved.

Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

PubMed

Kaiser, Lee D; Melemed, Allen S; Preston, Alaknanda J; Chaudri Ross, Hilary A; Niedzwiecki, Donna; Fyfe, Gwendolyn A; Gough, Jacqueline M; Bushnell, William D; Stephens, Cynthia L; Mace, M Kelsey; Abrams, Jeffrey S; Schilsky, Richard L

2010-12-01

Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications. Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials. A total of 107,884 adverse events and 136,608 concomitant medication records were reviewed for the analysis. Of these, four grade 1 to 2 and nine grade 3 and higher events were identified as drug effects that were not included in the previously established safety profiles and could potentially have been missed using subsampling. These events were frequently detected in subsamples of 400 patients or larger. Furthermore, none of the concomitant medication records contributed to labeling changes for the supplemental indications. Our study found that applying the optimized methodologic approach, described herein, has a high probability of detecting new drug safety signals. Focusing data collection on signals that cause physicians to modify or discontinue treatment ensures that safety issues of the highest concern for patients and regulators are captured and has significant potential to relieve strain on the clinical trials system.

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.

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

Joshi, Anjali; Heimdahl, Mats P. E.; Miller, Steven P.; Whalen, Mike W.

2006-01-01

System safety analysis techniques are well established and are used extensively during the design of safety-critical systems. Despite this, most of the techniques are highly subjective and dependent on the skill of the practitioner. Since these analyses are usually based on an informal system model, it is unlikely that they will be complete, consistent, and error free. In fact, the lack of precise models of the system architecture and its failure modes often forces the safety analysts to devote much of their effort to gathering architectural details about the system behavior from several sources and embedding this information in the safety artifacts such as the fault trees. This report describes Model-Based Safety Analysis, an approach in which the system and safety engineers share a common system model created using a model-based development process. By extending the system model with a fault model as well as relevant portions of the physical system to be controlled, automated support can be provided for much of the safety analysis. We believe that by using a common model for both system and safety engineering and automating parts of the safety analysis, we can both reduce the cost and improve the quality of the safety analysis. Here we present our vision of model-based safety analysis and discuss the advantages and challenges in making this approach practical.

Provider and patient expectations for dietary supplement discussions.

PubMed

Tarn, Derjung M; Guzmán, Jennifer R; Good, Jeffrey S; Wenger, Neil S; Coulter, Ian D; Paterniti, Debora A

2014-09-01

Dietary supplement use in the United States is common. Patients can procure supplements without a prescription, and often do not disclose supplement use to their healthcare providers. Providers and patients may be uncertain about what would be appropriate or helpful in discussions of supplements during routine office visits. To explore provider and patient expectations for discussions of dietary supplements. Semi-structured interviews were conducted with a purposeful sample of healthcare providers from three specialties and their patients who reported taking supplements. Thirty-five outpatient providers (14 primary care, six integrative medicine, and 15 complementary and alternative medicine (CAM) providers) and 107 of their patients. Qualitative analysis of transcripts using grounded theory and iterative review. Both providers and patients raised twelve common topics about dietary supplements that they felt were important to discuss during office visits, such as: supplements taken; supplement risks (interactions, safety/harm, side effects/adverse events); treatment benefits; efficacy; alternative treatments; and patient expectations/preferences for treatment. Some topics were mentioned more frequently by providers than patients, such as how to take, reason for taking, and evidence for use. Providers raised several topics that were mentioned infrequently by patients. Supplement costs and regulations were not brought up by any patients, even though consideration of these topics could influence patient decisions to take supplements. Complementary healthcare providers brought up topics not mentioned by primary care providers, such as the importance of supplement brands and supplement mega-dosing. Patients and providers have concordant views about the need to discuss patient supplement use and ensure patient safety. Patients may undervalue, be unaware of, or discount information about cost or regulations that could affect their decision-making about supplement use

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

Highway Safety Manual applied in Missouri - freeway/software.

DOT National Transportation Integrated Search

2016-06-01

AASHTOs Highway Safety Manual (HSM) facilitates the quantitative safety analysis of highway facilities. In a 2014 : supplement, freeway facilities were added to the original HSM manual which allows the modeling of highway : interchanges. This repo...

A Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Effectiveness and Safety of a Thermogenic Supplement in Addition to an Energy-Restricted Diet in Apparently Healthy Females.

PubMed

Kendall, Kristina L; Hyde, Parker N; Fairman, Ciaran M; Hollaway, Kaitlyn M; Mumford, Petey W; Haun, Cody T; Mobley, Brooks; Kephart, Wesley C; Tribby, Aaron C; Kimber, Dylan; Moon, Jordan R; Beck, Darren T; Roberts, Michael D; Young, Kaelin C

2017-11-02

The increasing interest in weight loss has seen a concurrent rise in the supplemental use of thermogenics to aid weight loss efforts. To date, the effectiveness and safety of supplemental proprietary blend thermogenics, in conjunction with high-protein energy-restricted diets have not been thoroughly evaluated. The purpose of this study was to investigate the efficacy of a low-calorie, high-protein diet with and without the concomitant use of a thermogenic supplement on body weight and body composition in apparently healthy females. Subjects were divided into three groups, Bizzy Diet+FitMiss Burn (BURN, N = 12), Bizzy Diet+Placebo (PLA, N = 13), and Control (CON, N = 14), and underwent two testing sessions separated by approximately 3 weeks. Resting blood pressure (BP), resting heart rate (RHR), clinical safety markers, body weight (BW), and body composition were assessed during each testing session. Repeated measures analysis of variance (ANOVA) revealed a significant effect for time relative to BW, total body fat mass (FM), leg FM, and trunk FM. Post hoc analysis revealed that the BURN and PLA groups experienced significant decreases in both BW and total body FM compared to CON (p <.05). There were no significant interactions for BP, RHR, or clinical safety markers over the course of the study. The Bizzy Diet, both with and without the addition of FitMiss Burn thermogenic, appears to be safe for short-term use and may lead to greater improvement in body composition and BW in an apparently healthy female population.

Safety and T Cell Modulating Effects of High Dose Vitamin D3 Supplementation in Multiple Sclerosis

PubMed Central

Smolders, Joost; Peelen, Evelyn; Thewissen, Mariëlle; Cohen Tervaert, Jan Willem; Menheere, Paul; Hupperts, Raymond; Damoiseaux, Jan

2010-01-01

Background A poor vitamin D status has been associated with a high disease activity of multiple sclerosis (MS). Recently, we described associations between vitamin D status and peripheral T cell characteristics in relapsing remitting MS (RRMS) patients. In the present study, we studied the effects of high dose vitamin D3 supplementation on safety and T cell related outcome measures. Methodology/Principal Findings Fifteen RRMS patients were supplemented with 20 000 IU/d vitamin D3 for 12 weeks. Vitamin D and calcium metabolism were carefully monitored, and T cell characteristics were studied by flowcytometry. All patients finished the protocol without side-effects, hypercalcaemia, or hypercalciuria. The median vitamin D status increased from 50 nmol/L (31–175) at week 0 to 380 nmol/L (151–535) at week 12 (P<0.001). During the study, 1 patient experienced an exacerbation of MS and was censored from the T cell analysis. The proportions of (naïve and memory) CD4+ Tregs remained unaffected. Although Treg suppressive function improved in several subjects, this effect was not significant in the total cohort (P = 0.143). An increased proportion of IL-10+ CD4+ T cells was found after supplementation (P = 0.021). Additionally, a decrease of the ratio between IFN-γ+ and IL-4+ CD4+ T cells was observed (P = 0.035). Conclusion/Significance Twelve week supplementation of high dose vitamin D3 in RRMS patients was well tolerated and did not induce decompensation of calcium metabolism. The skewing towards an anti-inflammatory cytokine profile supports the evidence on vitamin D as an immune-modulator, and may be used as outcome measure for upcoming randomized placebo-controlled trials. Trial Registration Clinicaltrials.gov NCT00940719 PMID:21179201

Effect of supplementation with rebamipide for Helicobacter pylori eradication therapy: a systematic review and meta-analysis.

PubMed

Nishizawa, Toshihiro; Nishizawa, Yuko; Yahagi, Naohisa; Kanai, Takanori; Takahashi, Masahiko; Suzuki, Hidekazu

2014-12-01

Several studies have reported that the application of rebamipide during the eradication of Helicobacter pylori can improve the eradication rate. However, the efficacy and safety are controversial. The present study systematically evaluated whether rebamipide improves the eradication rate of H. pylori by conducting a meta-analysis based on randomized controlled trials (RCTs). Literature searches were conducted in the following database: PubMed, the Cochrane Library, and the Igaku-chuo-zasshi database in Japan. A meta-analysis of all RCTs comparing rebamipide supplementation with non-rebamipide-containing therapy was performed. We identified six randomized trials (611 patients). Pooled H. pylori eradication rates by per-protocol analysis were 73.3% and 61.4% for patients with or without rebamipide, respectively. The odds ratio was 1.74 (95% confidence interval. 1.19-2.53). Supplementation with rebamipide might be effective in increasing the H. pylori eradication rates of proton-pump inhibitor-amoxicillin dual therapy. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

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

Safety of dietary supplementation with arginine in adult humans.

PubMed

McNeal, Catherine J; Meininger, Cynthia J; Wilborn, Colin D; Tekwe, Carmen D; Wu, Guoyao

2018-06-01

Previous studies with animals and humans have shown beneficial effects of dietary supplementation with L-arginine (Arg) on reducing white fat and improving health. At present, a long-term safe level of Arg administration to adult humans is unknown. The objective of this study was to conduct a randomized, placebo-controlled, clinical trial to evaluate the safety and tolerability of oral Arg in overweight or obese but otherwise healthy adults with a body mass index of ≥ 25 kg/m 2 . A total of 142 subjects completed a 7-day wash-in period using a 12 g Arg/day dose. All the remaining eligible 101 subjects who tolerated the wash-in dose (45 men and 56 women) were assigned randomly to ingest 0, 15 or 30 g Arg (as pharmaceutical-grade Arg-HCl) per day for 90 days. Arg was taken daily in at least two divided doses by mixing with a flavored beverage. At Days 0 and 90, blood pressures of study subjects were recorded, their physical examinations were performed, and their blood and 24-h urine samples were obtained to measure: (1) serum concentrations of amino acids, glucose, fatty acids, and related metabolites; and (2) renal, hepatic, endocrine and metabolic parameters. Our results indicate that the serum concentration of Arg in men or women increased (P < 0.05) progressively with increasing oral Arg doses from 0 to 30 g/day. Dietary supplementation with 30 g Arg/day reduced (P < 0.05) systolic blood pressure and serum glucose concentration in females, as well as serum concentrations of free fatty acids in both males and females. Based on physiological and biochemical variables, study subjects tolerated oral administration of 15 and 30 g Arg/day without adverse events. We conclude that a long-term safe level of dietary Arg supplementation is at least 30 g/day in adult humans.

Review of the ethnobotany, chemistry, biological activity and safety of the botanical dietary supplement Morinda citrifolia (noni).

PubMed

Pawlus, Alison D; Kinghorn, Douglas A

2007-12-01

Morinda citrifolia, commonly called noni, has a long history as a medicinal plant and its use as a botanical dietary supplement has grown tremendously in recent years. This has prompted a concomitant increase in research on the phytochemical constituents and biological activity of noni. A relatively large number of scientific publications on noni have been published in recent years, including a number of review articles. The goals of this review are to provide an updated categorization of the phytochemical constituents found in noni and to provide perspective for its extensive utilization as a major botanical dietary supplement. Included herein are a comprehensive list of known ethnobotanical uses and common names of M. citrifolia, a brief summary of relevant biological studies and a discussion of the safety of noni as a supplement.

Supplemental Hazard Analysis and Risk Assessment - Hydrotreater

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lowry, Peter P.; Wagner, Katie A.

A supplemental hazard analysis was conducted and quantitative risk assessment performed in response to an independent review comment received by the Pacific Northwest National Laboratory (PNNL) from the U.S. Department of Energy Pacific Northwest Field Office (PNSO) against the Hydrotreater/Distillation Column Hazard Analysis Report issued in April 2013. The supplemental analysis used the hazardous conditions documented by the previous April 2013 report as a basis. The conditions were screened and grouped for the purpose of identifying whether additional prudent, practical hazard controls could be identified, using a quantitative risk evaluation to assess the adequacy of the controls and establish amore » lower level of concern for the likelihood of potential serious accidents. Calculations were performed to support conclusions where necessary.« less

The efficacy and safety of selective leukocytapheresis in the treatment of ulcerative colitis: a meta-analysis.

PubMed

Zhu, Mingming; Xu, Xitao; Nie, Fang; Tong, Jinlu; Xiao, Shudong; Ran, Zhihua

2011-08-01

The use of selective leukocytapheresis for the treatment of ulcerative colitis (UC) has been evaluated in several open and controlled trials, with varying outcomes. A meta-analysis was performed to better assess the efficacy and safety of selective leukocytapheresis as supplemental therapy compared with conventional pharmacotherapy in patients with UC. All randomized trials comparing selective leukocytapheresis supplementation with conventional pharmacotherapy were included from electronic databases and reference lists. A meta-analysis that pooled the outcome effects of leukocytapheresis and pharmacotherapy was performed. A fixed effect model or random effect model was selected depending on the heterogeneity test of the trials. Nine randomized controlled trials met the inclusion criteria contributing a total of 686 participants. Compared with conventional pharmacotherapy, leukocytapheresis supplementation presented a significant benefit in promoting a response rate (OR, 2.88, 95% CI: 1.60-5.18) and remission rate (OR, 2.04; 95% CI, 1.36-3.07) together with significant higher steroid-sparing effects (OR, 10.49; 95% CI, 3.44-31.93) in patients with active moderate-to-severe UC by intention-to-treat analysis. Leukocytapheresis was more effective in maintaining clinical remission for asymptomatic UC patients than conventional therapy (OR, 8.14; 95% CI, 2.22-29.90). The incidence of mild-moderate adverse effects was much less frequent in the leukocytapheresis groups than conventional pharmacotherapy groups (OR, 0.16; 95% CI, 0.04-0.60). Few severe adverse events were observed. Current data indicate that leukocytapheresis supplementation may be more efficacious on improving response and remission rates and tapering corticosteroid dosage with excellent tolerability and safety than conventional pharmacotherapy in patients with UC. In addition, more high-quality randomized controlled trials are required to confirm the higher efficacy of leukocytapheresis in patients with UC.

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 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.

49 CFR 388.8 - Supplemental agreements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Supplemental agreements. 388.8 Section 388.8... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS COOPERATIVE AGREEMENTS WITH STATES § 388.8 Supplemental agreements. The terms specified in this part may be supplemented from time to...

49 CFR 388.8 - Supplemental agreements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Supplemental agreements. 388.8 Section 388.8... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS COOPERATIVE AGREEMENTS WITH STATES § 388.8 Supplemental agreements. The terms specified in this part may be supplemented from time to...

49 CFR 388.8 - Supplemental agreements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false Supplemental agreements. 388.8 Section 388.8... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS COOPERATIVE AGREEMENTS WITH STATES § 388.8 Supplemental agreements. The terms specified in this part may be supplemented from time to...

Safety Evaluation and Plasma Carotenoid Accumulation in Healthy Adult Subjects after 12 Weeks of Paprika Oleoresin Supplementation.

PubMed

Umigai, Naofumi; Murakami, Katsura; Shimizu, Ryoma; Takeda, Ryuji; Azuma, Takayuki

2018-02-01

Paprika oleoresin is obtained by solvent extraction from Capsicum annuum L. fruits and contains multiple carotenoids, such as capsanthin, β-carotene, zeaxanthin, and β-cryptoxanthin, which are considered protective against various diseases. Herein, we investigated the effect of paprika oleoresin supplementation on plasma carotenoid accumulation and evaluated the safety of the oleoresin. We used a double-blinded, placebo-controlled comparative clinical study design and tested the effects of varying doses in healthy adult subjects. In total, 33 subjects were randomly divided into three groups to take capsules containing 0, 20, or 100 mg of paprika oleoresin daily for 12 consecutive weeks. Plasma carotenoid concentrations were measured at 0, 4, 8, and 12 weeks, and the safety of paprika oleoresin capsules was investigated using analyses of blood biochemistry, hematology, and urine contents. In these experiments, β-cryptoxanthin and zeaxanthin dose-dependently accumulated in plasma within the dose range of the study over 12 consecutive weeks of paprika oleoresin supplementation. Moreover, β-cryptoxanthin accumulated to higher levels than the other paprika oleoresin carotenoids. In contrast, capsanthin was not detected in plasma before or during the 12-week treatment period. Finally, no adverse events were associated with intake of paprika oleoresin (20 and 100 mg/day) in safety evaluations. Paprika oleoresin is a suitable source of carotenoids, especially β-cryptoxanthin.

[Chromium supplementation in patients with type 2 diabetes and high risk of type 2 diabetes: a meta-analysis of randomized controlled trials].

PubMed

San Mauro-Martin, Ismael; Ruiz-León, Ana María; Camina-Martín, María Alicia; Garicano-Vilar, Elena; Collado-Yurrita, Luis; Mateo-Silleras, Beatriz de; Redondo Del Río, María De Paz

2016-02-16

Chromium is an essential trace mineral for carbohydrate and lipid metabolism, which is currently prescribed to control diabetes mellitus. Results of previous systematic reviews and meta-analyses of chromium supplementation and metabolic profiles in diabetes have been inconsistent. The objective of this meta-analysis was to assess the effects on metabolic profiles and safety of chromium supplementation in type 2 diabetes mellitus and cholesterol. Literature searches in PubMed, Scopus and Web of Science were made by use of related terms-keywords and randomized clinical trials during the period of 2000-2014. Thirteen trials fulfilled the inclusion criteria and were included in this systematic review. Total doses of Cr supplementation and brewer's yeast ranged from 42 to 1,000 μg/day, and duration of supplementation ranged from 30 to 120 days. The analysis indicated that there was a significant effect of chromium supplementation in diabetics on fasting plasma glucose with a weighted average effect size of -29.26 mg/dL, p = 0.01, CI 95% = -52.4 to -6.09; and on total cholesterol with a weighted average effect size of -6.7 mg/dL, p = 0.01, CI 95% = -11.88 to -1.53. The available evidence suggests favourable effects of chromium supplementation on glycaemic control in patients with diabetes.

Fish oil supplementation and insulin sensitivity: a systematic review and meta-analysis.

PubMed

Gao, Huanqing; Geng, Tingting; Huang, Tao; Zhao, Qinghua

2017-07-03

Fish oil supplementation has been shown to be associated with a lower risk of metabolic syndrome and benefit a wide range of chronic diseases, such as cardiovascular disease, type 2 diabetes and several types of cancers. However, the evidence of fish oil supplementation on glucose metabolism and insulin sensitivity is still controversial. This meta-analysis summarized the exist evidence of the relationship between fish oil supplementation and insulin sensitivity and aimed to evaluate whether fish oil supplementation could improve insulin sensitivity. We searched the Cochrane Library, PubMed, Embase database for the relevant studies update to Dec 2016. Two researchers screened the literature independently by the selection and exclusion criteria. Studies were pooled using random effect models to estimate a pooled SMD and corresponding 95% CI. This meta-analysis was performed by Stata 13.1 software. A total of 17 studies with 672 participants were included in this meta-analysis study after screening from 498 published articles found after the initial search. In a pooled analysis, fish oil supplementation had no effects on insulin sensitivity compared with the placebo (SMD 0.17, 95%CI -0.15 to 0.48, p = 0.292). In subgroup analysis, fish oil supplementation could benefit insulin sensitivity among people who were experiencing at least one symptom of metabolic disorders (SMD 0.53, 95% CI 0.17 to 0.88, p < 0.001). Similarly, there were no significant differences between subgroups of methods of insulin sensitivity, doses of omega-3 polyunsaturated fatty acids (n-3 PUFA) of fish oil supplementation or duration of the intervention. The sensitivity analysis indicated that the results were robust. Short-term fish oil supplementation is associated with increasing the insulin sensitivity among those people with metabolic disorders.

Probiotics Supplementation Therapy for Pathological Neonatal Jaundice: A Systematic Review and Meta-Analysis.

PubMed

Chen, Zhe; Zhang, Lingli; Zeng, Linan; Yang, Xiaoyan; Jiang, Lucan; Gui, Ge; Zhang, Zuojie

2017-01-01

Background: Neonatal jaundice is a relatively prevalent disease and affects approximately 2.4-15% newborns. Probiotics supplementation therapy could assist to improve the recovery of neonatal jaundice, through enhancing immunity mainly by regulating bacterial colonies. However, there is limited evidence regarding the effect of probiotics on bilirubin level in neonates. Therefore, this study aims at systematically evaluating the efficacy and safety of probiotics supplement therapy for pathological neonatal jaundice. Methods: Databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Database (Wan Fang), Chinese Biomedical Literature Database (CBM), VIP Database for Chinese Technical Periodicals (VIP) were searched and the deadline is December 2016. Randomized controlled trials (RCTs) of probiotics supplementation for pathological neonatal jaundice in publications were extracted by two reviewers. The cochrane tool was applied to assessing the risk of bias of the trials. The extracted information of RCTs should include efficacy rate, serum total bilirubin level, time of jaundice fading, duration of phototherapy, duration of hospitalization, adverse reactions. The main outcomes of the trials were analyzed by Review Manager 5.3 software. The relative risks (RR) or mean difference (MD) with a 95% confidence interval (CI) was used to measure the effect. Results: 13 RCTs involving 1067 neonatal with jaundice were included in the meta-analysis. Probiotics supplementation treatment showed efficacy [RR: 1.19, 95% CI (1.12, 1.26), P < 0.00001] in neonatal jaundice. It not only decreased the total serum bilirubin level after 3day [MD: -18.05, 95% CI (-25.51, -10.58), P < 0.00001], 5day [MD: -23.49, 95% CI (-32.80, -14.18), P < 0.00001], 7day [MD: -33.01, 95% CI (-37.31, -28.70), P < 0.00001] treatment, but also decreased time of jaundice fading [MD: -1.91, 95% CI (-2.06, -1.75), P < 0.00001], as well as the duration of

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Potential harmful effects of dietary supplements in sports medicine.

PubMed

Deldicque, Louise; Francaux, Marc

2016-11-01

The purpose of this article is to collect the most recent data regarding the safety of well-known or emerging dietary supplements used by athletes. From January 2014 to April 2016, about 30 articles have been published in the field. New data show that 90% of sports supplements contain trace of estrogenic endocrine disruptors, with 25% of them having a higher estrogenic activity than acceptable. About 50% of the supplements are contaminated by melamine, a source of nonprotein nitrogen. Additional data accumulate toward the safety of nitrate ingestion. In the last 2 years, the safety of emerging supplements such as higenamine, potentially interesting to lose weight, creatine nitrate and guanidinoacetic acid has been evaluated but still needs further investigation. The consumption of over-the-counter supplements is very popular in athletes. Although most supplements may be considered as safe when taking at the recommended doses, athletes should be aware of the potential risks linked to the consumption of supplements. In addition to the risks linked to overdosage and cross-effects when combining different supplements at the same time, inadvertent or deliberate contamination with stimulants, estrogenic compounds, diuretics or anabolic agents may occur.

Efficacy of Ginseng Supplements on Fatigue and Physical Performance: a Meta-analysis

PubMed Central

2016-01-01

We conducted a meta-analysis to investigate the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement as reported by randomized controlled trials (RCTs). RCTs that investigated the efficacy of ginseng supplements on fatigue reduction and physical performance enhancement compared with placebos were included. The main outcome measures were fatigue reduction and physical performance enhancement. Out of 155 articles meeting initial criteria, 12 RCTs involving 630 participants (311 participants in the intervention group and 319 participants in the placebo group) were included in the final analysis. In the fixed-effect meta-analysis of four RCTs, there was a statistically significant efficacy of ginseng supplements on fatigue reduction (standardized mean difference, SMD = 0.34; 95% confidence interval [CI] = 0.16 to 0.52). However, ginseng supplements were not associated with physical performance enhancement in the fixed-effect meta-analysis of eight RCTs (SMD = −0.01; 95% CI = −0.29 to 0.27). We found that there was insufficient clinical evidence to support the use of ginseng supplements on reducing fatigue and enhancing physical performance because only few RCTs with a small sample size have been published so far. Further lager RCTs are required to confirm the efficacy of ginseng supplements on fatigue reduction. PMID:27822924

Maca (Lepidium meyenii) and yacon (Smallanthus sonchifolius) in combination with silymarin as food supplements: in vivo safety assessment.

PubMed

Valentová, Katerina; Stejskal, David; Bartek, Josef; Dvorácková, Svatava; Kren, Vladimír; Ulrichová, Jitka; Simánek, Vilím

2008-03-01

Yacon and maca are native Andean crops with growing popularity as food supplements often in combination with other components, e.g. silymarin. There are however no published data on their toxicity and safety in humans. The aim of our randomized placebo-controlled 90-day study was to evaluate the effects of yacon and maca in combination with silymarin on plasma and lipoprotein lipids, serum glucose and safety parameters in patients suffering from the metabolic syndrome. No adverse effects were found in volunteers using silymarin (0.8 g/day), silymarin+yacon (0.8+2.4 g/day) and silymarin+maca (0.6+0.2 g/day). A moderate AST level and diastolic blood pressure increase was found in volunteers using maca (0.6 g/day). In conclusion, the combination silymarin+yacon appears to be promising as a nutraceutical in the prevention of diseases with a proatherogenic lipoprotein profile and liver steatosis. The effect of maca on AST level and blood pressure must be considered when using high doses of maca powder. This effect could be reversed by supplementation with silymarin.

Efficacy and safety of protein supplements for U.S. Armed Forces personnel: consensus statement.

PubMed

Pasiakos, Stefan M; Austin, Krista G; Lieberman, Harris R; Askew, E Wayne

2013-11-01

To provide evidence-based guidance regarding the efficacy and safety of dietary protein supplement (PS) use by members of the U.S. Armed Forces, a panel of internationally recognized experts in the fields of protein metabolism and dietary supplement research was convened by the Department of Defense Center Alliance for Dietary Supplement Research and the U.S. Army Medical Research and Material Command. To develop a consensus statement, potential benefits, risks, and strategies to optimize military performance through PS use were considered in the context of specific warfighter populations and occupational demands. To maintain muscle mass, strength, and performance during periods of substantial metabolic demand and concomitant negative energy balance the panel recommended that warfighters consume 1.5-2.0 g · kg(-1) · d(-1) of protein. However, if metabolic demand is low, such as in garrison, protein intake should equal the current Military Dietary Reference Intake (0.8-1.5 g · kg(-1) · d(-1)). Although PS use generally appears to be safe for healthy adults, warfighters should be educated on PS quality, given quality-control and contamination concerns with commercial dietary supplements. To achieve recommended protein intakes, the panel strongly urges consumption of high-quality protein-containing whole foods. However, when impractical, the use of PSs (20-25 g per serving or 0.25-0.3 g · kg(-1) per meal), particularly after periods of strenuous physical activity (e.g., military training, combat patrols, and exercise), is acceptable. The committee acknowledges the need for further study of protein requirements for extreme, military-specific environmental conditions and whether unique metabolic stressors associated with military service alter protein requirements for aging warfighters.

Supplement use by women during pregnancy: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

PubMed

Freeman, Marlene P; Sosinsky, Alexandra Z; Moustafa, Danna; Viguera, Adele C; Cohen, Lee S

2016-06-01

Women of reproductive age commonly use integrative treatments. However, the reproductive safety for most complementary products lacks systematic study. We aimed to study the use of supplements by women in a prospective pregnancy registry. The Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics was established to evaluate the reproductive safety of atypical antipsychotics. Exposed and control participants were systematically queried about the use of vitamins and supplements. Slightly greater than half (53.2 %) of the participants eligible for analysis (N = 534) were using at least one vitamin or supplement at the time of enrollment, not including prenatal vitamins or folic acid. The most common supplements used were omega-3 fatty acids (38.0 %), vitamin D (11.0 %), calcium (8.2 %), and iron (4.7 %). Probiotics and melatonin were used by 2.6 and 0.9 %, respectively. In this prospective pregnancy registry, we found that over half of the participants were taking supplements or vitamins other than prenatal vitamins and folic acid. These findings underscore the need for active query on the part of health care providers about the use of supplements during pregnancy, and the need to obtain rigorous reproductive safety and efficacy data for supplements used by pregnant women and reproductive aged women.

30 CFR 75.361 - Supplemental examination.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.361 Supplemental examination. (a) Except... examine the area for hazardous conditions, determine whether the air is traveling in its proper direction...

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Documented safety analysis. 830.204 Section 830.204 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.204 Documented safety analysis... approval from DOE for the methodology used to prepare the documented safety analysis for the facility...

Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial.

PubMed

Smilowitz, Jennifer T; Moya, Jackelyn; Breck, Melissa A; Cook, Chelsea; Fineberg, Annette; Angkustsiri, Kathleen; Underwood, Mark A

2017-05-30

Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation of breastfed, healthy, term infants with this organism, has not been reported. The IMPRINT Study, a Phase I clinical trial, was initiated to determine the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001). Eighty mother-infant dyads were enrolled in either lactation support plus B. infantis supplementation (BiLS) or lactation support alone (LS). Starting with Day 7 postnatal, BiLS infants were fed 1.8-2.8 × 10 10  CFU B. infantis EVC001 daily in breast milk for 21 days. Mothers collected fecal samples, filled out health questionnaires, and kept daily logs about their infants' feeding and gastrointestinal symptoms from birth until Day 61 postnatal. Safety and tolerability were determined from maternal reports. There were no differences in the mean gestational age at birth, weight 1 and 2 months postnatal, and breast milk intake between groups. The mean Log 10 change in fecal Bifidobacterium from Day 6 to Day 28 was higher (p = 0.0002) for BiLS (6.6 ± 2.8 SD) than for LS infants (3.5 ± 3.5 SD). Daily stool number was higher (p < 0.005) for LS and lower (p < 0.05) for BiLS infants during supplementation than at Baseline. During supplementation, watery stools decreased and soft stools increased by 36% over baseline in BiLS infants (p < 0.05) with no significant changes in stool consistency for the LS infants. None of the safety and tolerability endpoints, including flatulence, bloody stool, body temperature, ratings of gastrointestinal symptoms, use of antibiotics or gas-relieving medications, infant colic, jaundice, number

[ERGOGENIC SPORT SUPPLEMENTS FOR ATHLETES].

PubMed

Arieli, Rakefet; Lahav, Yair

2016-06-01

Use of performance-enhancing supplements occurs at all levels of sports, from recreational athletes to professional athletes. Although some supplements do enhance athletic performance, many have no proven benefits and have adverse effects. Nutritional supplements are categorized into the following categories: I. Apparently Effective. II. Possibly Effective. III. Too Early To Tell. IV. Apparently Ineffective. This article will review 4 ergogenic supplements which are categorized in the first category--"Apparently Effective"--1) Buffer agents 2) Creatine 3) Caffeine and 4 Nitric Oxide. Given the widespread use of performance enhancing supplements, physicians, and dietitians should be prepared to counsel athletes about their effectiveness, safety and legality.

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.

Probiotics Supplementation Therapy for Pathological Neonatal Jaundice: A Systematic Review and Meta-Analysis

PubMed Central

Chen, Zhe; Zhang, Lingli; Zeng, Linan; Yang, Xiaoyan; Jiang, Lucan; Gui, Ge; Zhang, Zuojie

2017-01-01

Background: Neonatal jaundice is a relatively prevalent disease and affects approximately 2.4–15% newborns. Probiotics supplementation therapy could assist to improve the recovery of neonatal jaundice, through enhancing immunity mainly by regulating bacterial colonies. However, there is limited evidence regarding the effect of probiotics on bilirubin level in neonates. Therefore, this study aims at systematically evaluating the efficacy and safety of probiotics supplement therapy for pathological neonatal jaundice. Methods: Databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Database (Wan Fang), Chinese Biomedical Literature Database (CBM), VIP Database for Chinese Technical Periodicals (VIP) were searched and the deadline is December 2016. Randomized controlled trials (RCTs) of probiotics supplementation for pathological neonatal jaundice in publications were extracted by two reviewers. The cochrane tool was applied to assessing the risk of bias of the trials. The extracted information of RCTs should include efficacy rate, serum total bilirubin level, time of jaundice fading, duration of phototherapy, duration of hospitalization, adverse reactions. The main outcomes of the trials were analyzed by Review Manager 5.3 software. The relative risks (RR) or mean difference (MD) with a 95% confidence interval (CI) was used to measure the effect. Results: 13 RCTs involving 1067 neonatal with jaundice were included in the meta-analysis. Probiotics supplementation treatment showed efficacy [RR: 1.19, 95% CI (1.12, 1.26), P < 0.00001] in neonatal jaundice. It not only decreased the total serum bilirubin level after 3day [MD: −18.05, 95% CI (−25.51, −10.58), P < 0.00001], 5day [MD: -23.49, 95% CI (−32.80, −14.18), P < 0.00001], 7day [MD: −33.01, 95% CI (−37.31, −28.70), P < 0.00001] treatment, but also decreased time of jaundice fading [MD: −1.91, 95% CI (−2.06, −1.75), P < 0.00001], as well as

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.

International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine.

PubMed

Kreider, Richard B; Kalman, Douglas S; Antonio, Jose; Ziegenfuss, Tim N; Wildman, Robert; Collins, Rick; Candow, Darren G; Kleiner, Susan M; Almada, Anthony L; Lopez, Hector L

2017-01-01

Creatine is one of the most popular nutritional ergogenic aids for athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations which may help explain the observed improvements in high intensity exercise performance leading to greater training adaptations. In addition to athletic and exercise improvement, research has shown that creatine supplementation may enhance post-exercise recovery, injury prevention, thermoregulation, rehabilitation, and concussion and/or spinal cord neuroprotection. Additionally, a number of clinical applications of creatine supplementation have been studied involving neurodegenerative diseases (e.g., muscular dystrophy, Parkinson's, Huntington's disease), diabetes, osteoarthritis, fibromyalgia, aging, brain and heart ischemia, adolescent depression, and pregnancy. These studies provide a large body of evidence that creatine can not only improve exercise performance, but can play a role in preventing and/or reducing the severity of injury, enhancing rehabilitation from injuries, and helping athletes tolerate heavy training loads. Additionally, researchers have identified a number of potentially beneficial clinical uses of creatine supplementation. These studies show that short and long-term supplementation (up to 30 g/day for 5 years) is safe and well-tolerated in healthy individuals and in a number of patient populations ranging from infants to the elderly. Moreover, significant health benefits may be provided by ensuring habitual low dietary creatine ingestion (e.g., 3 g/day) throughout the lifespan. The purpose of this review is to provide an update to the current literature regarding the role and safety of creatine supplementation in exercise, sport, and medicine and to update the position stand of International Society of Sports Nutrition (ISSN).

47 CFR 87.321 - Supplemental eligibility.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 5 2014-10-01 2014-10-01 false Supplemental eligibility. 87.321 Section 87.321 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aviation Support Stations § 87.321 Supplemental eligibility. Each applicant must certify as to its...

47 CFR 87.321 - Supplemental eligibility.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 5 2012-10-01 2012-10-01 false Supplemental eligibility. 87.321 Section 87.321 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aviation Support Stations § 87.321 Supplemental eligibility. Each applicant must certify as to its...

47 CFR 87.321 - Supplemental eligibility.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 5 2013-10-01 2013-10-01 false Supplemental eligibility. 87.321 Section 87.321 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aviation Support Stations § 87.321 Supplemental eligibility. Each applicant must certify as to its...

47 CFR 87.321 - Supplemental eligibility.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Supplemental eligibility. 87.321 Section 87.321 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aviation Support Stations § 87.321 Supplemental eligibility. Each applicant must certify as to its...

47 CFR 87.239 - Supplemental eligibility.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Supplemental eligibility. 87.239 Section 87.239 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aeronautical Multicom Stations § 87.239 Supplemental eligibility. Each applicant for a multicom may be required...

47 CFR 87.527 - Supplemental eligibility.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Supplemental eligibility. 87.527 Section 87.527 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only...

47 CFR 87.527 - Supplemental eligibility.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 5 2014-10-01 2014-10-01 false Supplemental eligibility. 87.527 Section 87.527 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only...

47 CFR 87.527 - Supplemental eligibility.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 5 2013-10-01 2013-10-01 false Supplemental eligibility. 87.527 Section 87.527 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only...

47 CFR 87.527 - Supplemental eligibility.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 5 2012-10-01 2012-10-01 false Supplemental eligibility. 87.527 Section 87.527 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only...

47 CFR 87.527 - Supplemental eligibility.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false Supplemental eligibility. 87.527 Section 87.527 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only...

Dietary supplements for dysmenorrhoea.

PubMed

Pattanittum, Porjai; Kunyanone, Naowarat; Brown, Julie; Sangkomkamhang, Ussanee S; Barnes, Joanne; Seyfoddin, Vahid; Marjoribanks, Jane

2016-03-22

Dysmenorrhoea refers to painful menstrual cramps and is a common gynaecological complaint. Conventional treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptive pills (OCPs), which both reduce myometrial activity (contractions of the uterus). A suggested alternative approach is dietary supplements. We used the term 'dietary supplement' to include herbs or other botanical, vitamins, minerals, enzymes, and amino acids. We excluded traditional Chinese medicines. To determine the efficacy and safety of dietary supplements for treating dysmenorrhoea. We searched sources including the Cochrane Gynaecology and Fertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, PsycINFO (all from inception to 23 March 2015), trial registries, and the reference lists of relevant articles. We included randomised controlled trials (RCTs) of dietary supplements for moderate or severe primary or secondary dysmenorrhoea. We excluded studies of women with an intrauterine device. Eligible comparators were other dietary supplements, placebo, no treatment, or conventional analgesia. Two review authors independently performed study selection, performed data extraction and assessed the risk of bias in the included trials. The primary outcomes were pain intensity and adverse effects. We used a fixed-effect model to calculate odds ratios (ORs) for dichotomous data, and mean differences (MDs) or standardised mean differences (SMDs) for continuous data, with 95% confidence intervals (CIs). We presented data that were unsuitable for analysis either descriptively or in additional tables. We assessed the quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. We included 27 RCTs (3101 women). Most included studies were conducted amongst cohorts of students with primary dysmenorrhoea in their late teens or early twenties. Twenty-two studies were

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.

Raspberry ketone in food supplements--High intake, few toxicity data--A cause for safety concern?

PubMed

Bredsdorff, Lea; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev; Hallas-Møller, Torben; Pilegaard, Kirsten

2015-10-01

Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic effects and potential effects on reproduction/development. Taking into account the high intake via supplements, the compound's toxic potential should be clarified with further experimental studies. In UK the pure compound is regarded as novel food requiring authorisation prior to marketing but raspberry ketone is not withdrawn from Internet sites from this country. Copyright © 2015 Elsevier Inc. All rights reserved.

A safety assessment of Coriolus versicolor biomass as a food supplement

PubMed Central

Barros, Ana B.; Ferrão, Jorge; Fernandes, Tito

2016-01-01

Background Coriolus versicolor (CV) is a common mushroom with antitumor, anti-inflammatory, antioxidant, antiviral, antibacterial, and immunomodulatory properties. The existence of these properties has been extensively proven mainly using CV extract; research on the biomass form is scarce. Objective The aim of this study was to investigate the safety of the CV biomass form, as it is commonly used as a food supplement. Design CV biomass powder was dissolved in distilled water and administered daily (2.5, 5.0, and 7.5 g/kg live weight) in single doses by gavage to both female and male Charles River albino rats. Results No adverse or lethal effects were observed as a consequence of the daily administration of CV biomass. In addition, compared with the control group, no abnormal findings were observed at necropsy and histopathological examination. Conclusions A safe profile of CV biomass for human consumption can be inferred from the absence of any remarkable adverse effects in rats. PMID:26969586

A safety assessment of Coriolus versicolor biomass as a food supplement.

PubMed

Barros, Ana B; Ferrão, Jorge; Fernandes, Tito

2016-01-01

Coriolus versicolor (CV) is a common mushroom with antitumor, anti-inflammatory, antioxidant, antiviral, antibacterial, and immunomodulatory properties. The existence of these properties has been extensively proven mainly using CV extract; research on the biomass form is scarce. The aim of this study was to investigate the safety of the CV biomass form, as it is commonly used as a food supplement. CV biomass powder was dissolved in distilled water and administered daily (2.5, 5.0, and 7.5 g/kg live weight) in single doses by gavage to both female and male Charles River albino rats. No adverse or lethal effects were observed as a consequence of the daily administration of CV biomass. In addition, compared with the control group, no abnormal findings were observed at necropsy and histopathological examination. A safe profile of CV biomass for human consumption can be inferred from the absence of any remarkable adverse effects in rats.

Effect of soy isoflavone supplementation on plasma lipoprotein(a) concentrations: A meta-analysis.

PubMed

Simental-Mendía, Luis E; Gotto, Antonio M; Atkin, Stephen L; Banach, Maciej; Pirro, Matteo; Sahebkar, Amirhossein

Soy supplementation has been shown to reduce total and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol. However, contradictory effects of soy isoflavone supplementation on lipoprotein(a) [Lp(a)] have been reported suggesting the need for a meta-analysis to be undertaken. The aim of the study was to investigate the impact of supplementation with soy isoflavones on plasma Lp(a) levels through a systematic review and meta-analysis of eligible randomized placebo-controlled trials. The search included PubMed-Medline, Scopus, ISI Web of Knowledge, and Google Scholar databases (by March 26, 2017), and quality of studies was evaluated according to Cochrane criteria. Quantitative data synthesis was performed using a random-effects model, with standardized mean difference and 95% confidence interval as summary statistics. Meta-regression and leave-one-out sensitivity analysis were performed to assess the modifiers of treatment response. Ten eligible studies comprising 11 treatment arms with 973 subjects were selected for the meta-analysis. Meta-analysis did not suggest any significant alteration of plasma Lp(a) levels after supplementation with soy isoflavones (standardized mean difference: 0.08, 95% confidence interval: -0.05, 0.20, P = .228). The effect size was robust in the leave-one-out sensitivity analysis. In meta-regression analysis, neither dose nor duration of supplementation with soy isoflavones was significantly associated with the effect size. This meta-analysis of the 10 available randomized placebo-controlled trials revealed no significant effect of soy isoflavones treatment on plasma Lp(a) concentrations. Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Effectiveness and safety of nutritional supplements in the treatment of hereditary retinal dystrophies: a systematic review

PubMed Central

Brito-García, N; del Pino-Sedeño, T; Trujillo-Martín, M M; Coco, R M; Rodríguez de la Rúa, E; del Cura-González, I; Serrano-Aguilar, P

2017-01-01

The hereditary retinal dystrophies (HRDs) are a group of genetically determined disorders that result in loss of the visual function. There is a lack of standard pharmacological treatments or widely accepted nutritional recommendations. The objective of this review is to summarise the scientific evidence on the effectiveness and safety of nutritional supplements for the treatment of HRDs. We conducted a scientific literature search on Medline and PreMedline, EMBASE, SCI-EXPANDED, SSCI, and The Cochrane Library up to August 2014. Experimental, quasi-experimental and controlled observational studies were selected. Eight studies were ultimately included, seven on retinitis pigmentosa (RP) and one on Best disease. Vitamin A, vitamin E, docosahexaenoic acid (DHA), lutein and β-carotene were assessed. A 15 000 IU daily dose of vitamin A was reported to have shown a small protective effect on the progression of RP, as was the use of the carotenoids lutein and β-carotene. Different DHA doses has no effect on RP or Best disease. No supplement showed severe adverse effects in the selected studies although strong evidence of toxicity exists for high doses of vitamin A and β-carotene in certain populations. The selected studies concluded that there may be a small beneficial effect of vitamin A, lutein and β-carotene on the progression of RP. The limited evidence available indicates some well-designed additional studies on combined supplements strategies may achieve more robust conclusions. Moreover, the scarcity of evidence available on the treatment of HRD other than RP with nutritional supplements supports the need for further research efforts. PMID:27935602

Dietary supplements for athletes: emerging trends and recurring themes.

PubMed

Maughan, R J; Greenhaff, P L; Hespel, P

2011-01-01

Dietary supplements are widely used at all levels of sport. Changes in patterns of supplement use are taking place against a background of changes in the regulatory framework that governs the manufacture and distribution of supplements in the major markets. Market regulation is complicated by the increasing popularity of Internet sales. The need for quality control of products to ensure they contain the listed ingredients in the stated amount and to ensure the absence of potentially harmful substances is recognized. This latter category includes compounds prohibited under anti-doping regulations. Several certification programmes now provide testing facilities for manufacturers of both raw ingredients and end products to ensure the absence of prohibited substances. Athletes should carry out a cost-benefit analysis for any supplement they propose to use. For most supplements, the evidence is weak, or even completely absent. A few supplements, including caffeine, creatine, and bicarbonate, are supported by a strong research base. Difficulties arise when new evidence appears to support novel supplements: in recent years, β-alanine has become popular, and the use of nitrate and arginine is growing. Athletes seldom wait until there is convincing evidence of efficacy or of safety, but caution is necessary to minimize risk.

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.

A Tiered Approach for the Evaluation of the Safety of Botanicals Used as Dietary Supplements: An Industry Strategy.

PubMed

Roe, Amy L; McMillan, Donna A; Mahony, Catherine

2018-06-08

Exposure to botanicals in dietary supplements is increasing across many geographies; with increased expectations from consumers, regulators, and industry stewards centered on quality and safety of these products. We present a tiered approach to assess the safety of botanicals, and an in silico decision tree to address toxicity data gaps. Tier 1 describes a Threshold of Toxicologic Concern (TTC) approach that can be used to assess the safety of conceptual levels of botanicals. Tier 2 is an approach to document a history of safe human use for botanical exposures higher than the TTC. An assessment of botanical-drug interaction (BDI) may also be necessary at this stage. Tier 3 involves botanical chemical constituent identification and safety assessment and the in silico approach as needed. Our novel approaches to identify potential hazards and establish safe human use levels for botanicals is cost and time efficient and minimizes reliance on animal testing. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Drugs and driving : a selected bibliography : supplement one.

DOT National Transportation Integrated Search

1978-01-01

This report presents a first supplement to Drugs and Driving: A : Selected Bibliography (HS - 802 188), a bibliography of literature : dealing with the relationship between drug use (other than alcohol alone) : and highway safety. This supplement bot...

European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

PubMed

Coppens, Patrick; da Silva, Miguel Fernandes; Pettman, Simon

2006-04-03

This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including

DHA supplementation and pregnancy outcomes123

PubMed Central

Colombo, John; Gajewski, Byron J; Gustafson, Kathleen M; Mundy, David; Yeast, John; Georgieff, Michael K; Markley, Lisa A; Kerling, Elizabeth H; Shaddy, D Jill

2013-01-01

Background: Observational studies associate higher intakes of n−3 (omega-3) long-chain polyunsaturated fatty acids (LCPUFAs) during pregnancy with higher gestation duration and birth size. The results of randomized supplementation trials using various n−3 LCPUFA sources and amounts are mixed. Objective: We tested the hypothesis that 600 mg/d of the n−3 LCPUFA docosahexaenoic acid (DHA) can increase maternal and newborn DHA status, gestation duration, birth weight, and length. Safety was assessed. Design: This phase III, double-blind, randomized controlled trial was conducted between January 2006 and October 2011. Women (n = 350) consumed capsules (placebo, DHA) from <20 wk of gestation to birth. Blood (enrollment, birth, and cord) was analyzed for red blood cell (RBC) phospholipid DHA. The statistical analysis was intent-to-treat. Results: Most of the capsules were consumed (76% placebo; 78% DHA); the mean DHA intake for the treated group was 469 mg/d. In comparison with placebo, DHA supplementation resulted in higher maternal and cord RBC-phospholipid-DHA (2.6%; P < 0.001), longer gestation duration (2.9 d; P = 0.041), and greater birth weight (172 g; P = 0.004), length (0.7 cm; P = 0.022), and head circumference (0.5 cm; P = 0.012). In addition, the DHA group had fewer infants born at <34 wk of gestation (P = 0.025) and shorter hospital stays for infants born preterm (40.8 compared with 8.9 d; P = 0.026) than did the placebo group. No safety concerns were identified. Conclusions: A supplement of 600 mg DHA/d in the last half of gestation resulted in overall greater gestation duration and infant size. A reduction in early preterm and very-low birth weight could be important clinical and public health outcomes of DHA supplementation. This trial was registered at clinicaltrials.gov as NCT00266825. PMID:23426033

Creatine Supplementation and Upper Limb Strength Performance: A Systematic Review and Meta-Analysis.

PubMed

Lanhers, Charlotte; Pereira, Bruno; Naughton, Geraldine; Trousselard, Marion; Lesage, François-Xavier; Dutheil, Frédéric

2017-01-01

Creatine is the most widely used supplementation to increase performance in strength; however, the most recent meta-analysis focused specifically on supplementation responses in muscles of the lower limbs without regard to upper limbs. We aimed to systematically review the effect of creatine supplementation on upper limb strength performance. We conducted a systematic review and meta-analyses of all randomized controlled trials comparing creatine supplementation with a placebo, with strength performance measured in exercises shorter than 3 min in duration. The search strategy used the keywords 'creatine', 'supplementation', and 'performance'. Independent variables were age, sex and level of physical activity at baseline, while dependent variables were creatine loading, total dose, duration, time interval between baseline (T0) and the end of the supplementation (T1), and any training during supplementation. We conducted three meta-analyses: at T0 and T1, and on changes between T0 and T1. Each meta-analysis was stratified within upper limb muscle groups. We included 53 studies (563 individuals in the creatine supplementation group and 575 controls). Results did not differ at T0, while, at T1, the effect size (ES) for bench press and chest press were 0.265 (95 % CI 0.132-0.398; p < 0.001) and 0.677 (95 % CI 0.149-1.206; p = 0.012), respectively. Overall, pectoral ES was 0.289 (95 % CI 0.160-0.419; p = 0.000), and global upper limb ES was 0.317 (95 % CI 0.185-0.449; p < 0.001). Meta-analysis of changes between T0 and T1 gave similar results. The meta-regression showed no link with characteristics of population or supplementation, demonstrating the efficacy of creatine independently of all listed conditions. Creatine supplementation is effective in upper limb strength performance for exercise with a duration of less than 3  min, independent of population characteristics, training protocols, and supplementary doses or duration.

47 CFR 80.21 - Supplemental information required.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Supplemental information required. 80.21 Section 80.21 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Applications and Licenses § 80.21 Supplemental information required. Applications must contain supplementary...

Confidence in the efficacy and safety of dietary supplements among United States active duty army personnel.

PubMed

Carvey, Christina E; Farina, Emily K; Lieberman, Harris R

2012-10-10

United States Army Soldiers regularly use dietary supplements (DS) to promote general health, enhance muscle strength, and increase energy, but limited scientific evidence supports the use of many DS for these benefits. This study investigated factors associated with Soldiers' confidence in the efficacy and safety of DS, and assessed Soldiers' knowledge of federal DS regulatory requirements. Between 2006 and 2007, 990 Soldiers were surveyed at 11 Army bases world-wide to assess their confidence in the effectiveness and safety of DS, knowledge of federal DS regulations, demographic characteristics, lifestyle-behaviors and DS use. A majority of Soldiers were at least somewhat confident that DS work as advertised (67%) and thought they are safe to consume (71%). Confidence in both attributes was higher among regular DS users than non-users. Among users, confidence in both attributes was positively associated with rank, self-rated diet quality and fitness level, education, and having never experienced an apparent DS-related adverse event. Fewer than half of Soldiers knew the government does not require manufacturers to demonstrate efficacy, and almost a third incorrectly believed there are effective pre-market federal safety requirements for DS. Despite limited scientific evidence supporting the purported benefits and safety of many popular DS, most Soldiers were confident that DS are effective and safe. The positive associations between confidence and DS use should be considered when developing DS-related interventions or policies. Additionally, education to clarify Soldiers' misperceptions about federal DS safety and efficacy regulations is warranted.

Effects and safety of periconceptional folate supplementation for preventing birth defects

PubMed Central

Maria De-Regil, Luz; Fernández-Gaxiola, Ana C; Dowswell, Therese; Peña-Rosas, Juan Pablo

2014-01-01

Background It has been reported that neural tube defects can be prevented with periconceptional folic acid supplementation. The effects of different doses, forms and schemes of folate supplementation for the prevention of other birth defects and maternal and infant outcomes are unclear. Objectives This review updates and expands a previous Cochrane Review assessing the effects of periconceptional supplementation with folic acid to reduce neural tube defects (NTDs). We examined whether folate supplementation before and during early pregnancy can reduce neural tube and other birth defects (including cleft palate) without causing adverse outcomes for mothers or babies. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (July 2010). Additionally, we searched the international clinical trials registry platform and contacted relevant organisations to identify ongoing and unpublished studies. Selection criteria We included all randomised or quasi-randomised trials evaluating the effect of periconceptional folate supplementation alone, or in combination with other vitamins and minerals, in women independent of age and parity. Data collection and analysis We assessed trials for methodological quality using the standard Cochrane criteria. Two authors independently assessed the trials for inclusion, one author extracted data and a second checked for accuracy. Main results Five trials involving 6105 women (1949 with a history of a pregnancy affected by a NTD and 4156 with no history of NTDs) were included. Overall, the results are consistent in showing a protective effect of daily folic acid supplementation (alone or in combination with other vitamins and minerals) in preventing NTDs compared with no interventions/placebo or vitamins and minerals without folic acid (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.15 to 0.52). Only one study assessed the incidence of NTDs and the effect was not statistically significant (RR 0.08, 95

30 CFR 75.361 - Supplemental examination.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Supplemental examination. 75.361 Section 75.361... MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.361 Supplemental examination. (a)(1...) and 75.220(a)(1)—roof control; (ii) §§ 75.333(h) and 75.370(a)(1)—ventilation, methane; (iii) §§ 75...

Effects of zinc supplementation on diabetes mellitus: a systematic review and meta-analysis

PubMed Central

2012-01-01

The number of people with diabetes and pre-diabetes are exponentially increasing. Studies on humans have shown the beneficial effects of Zinc supplementation in patients with diabetes. The present study aims to systematically evaluate the literature and meta-analyze the effects of Zinc supplementation on diabetes. A systematic review of published studies reporting the effects of Zinc supplementations on diabetes mellitus was undertaken. The literature search was conducted in the following databases; PubMed, Web of Science and SciVerse Scopus. A meta-analysis of studies examining the effects of Zinc supplementation on clinical and biochemical parameters in patients with diabetes was performed. The total number of articles included in the present review is 25, which included 3 studies on type-1 diabetes and 22 studies on type-2 diabetes. There were 12 studies comparing the effects of Zinc supplementation on fasting blood glucose in patients with type-2 diabetes. The pooled mean difference in fasting blood glucose between Zinc supplemented and placebo groups was 18.13mg/dl (95%CI:33.85,2.41; p<0.05). 2-h post-prandial blood sugar also shows a similar distinct reduction in (34.87mg/dl [95%CI:75.44; 5.69]) the Zinc treated group. The reduction in HbA1c was 0.54% (95%CI:0.86;0.21) in the Zinc treated group. There were 8 studies comparing the effects of Zinc supplementation on lipid parameters in patients with type-2 diabetes. The pooled mean difference for total cholesterol between Zinc supplemented and placebo groups was 32.37mg/dl (95%CI:57.39,7.35; p<0.05). Low-density lipoprotein cholesterol also showed a similar distinct reduction in the Zinc treated group, the pooled mean difference from random effects analysis was 11.19mg/dl (95%CI:21.14,1.25; p<0.05). Studies have also shown a significant reduction in systolic and diastolic blood pressures after Zinc supplementation. This first comprehensive systematic review and meta-analysis on the effects of Zinc

Transportation systems safety hazard analysis tool (SafetyHAT) user guide (version 1.0)

DOT National Transportation Integrated Search

2014-03-24

This is a user guide for the transportation system Safety Hazard Analysis Tool (SafetyHAT) Version 1.0. SafetyHAT is a software tool that facilitates System Theoretic Process Analysis (STPA.) This user guide provides instructions on how to download, ...

A point-of-sale communications campaign to provide consumers safety information on drug-dietary supplement interactions: a pilot study.

PubMed

Perlman, Adam I; Lebow, David G; Raphael, Karen; Ali, Ather; Simmons, Leigh Ann

2013-01-01

Concurrent use of dietary supplements with over-the-counter and prescription pharmaceuticals has become increasingly common, and with this trend, so has the incidence of adverse drug-supplement interactions. In the current market, consumers have no way to distinguish between safe and potentially harmful supplements. Thus, the primary objective of this study was to test the hypothesis that messages designed to increase consumers' awareness of potential health risks of concurrent use of dietary supplements with over-the-counter and prescription pharmaceuticals would promote further consideration and action, as evidenced by (a) seeking additional information from an authoritative source or qualified health care professional and (b) changing dietary supplement usage patterns. To test this hypothesis, an innovative consumer information delivery system, referred to as the Buyer Information Network (BuyIN), was utilized. BuyIN uses currently available, Web-enabled point-of-sale (POS) technology to provide up-to-date, evidence-based, health- and safety-related messages to consumers at the retail checkout counter. Results showed that more than one-fourth (27.1%) of consumers (n = 199) who purchased targeted items reported they were aware of the messages. Of this subgroup of aware consumers, 11.2% reported that they sought additional information from a physician or pharmacist, 11.5% reported that they visited the website listed on the coupon, and 10.5% indicated that they changed their dietary supplement usage patterns as a result of the messages. Future research should include a large-scale study of a fully implemented and capable system at multiple test sites around the country, including investigating the utility of BuyIN in different retail settings.

A Point-of-Sale Communications Campaign to Provide Consumers Safety Information on Drug-Dietary Supplement Interactions:A Pilot Study

PubMed Central

Perlman, Adam I.; Lebow, David G.; Raphael, Karen; Ali, Ather; Simmons, Leigh Ann

2013-01-01

Concurrent use of dietary supplements with over-the-counter and prescription pharmaceuticals has become increasingly common, and with this trend, so has the incidence of adverse drug–supplement interactions. In the current market, consumers have no way to distinguish between safe and potentially harmful supplements. Thus, the primary objective of this study was to test the hypothesis that messages designed to increase consumers' awareness of potential health risks of concurrent use of dietary supplements with over-the-counter and prescription pharmaceuticals would promote further consideration and action, as evidenced by (a) seeking additional information from an authoritative source or qualified health care professional and (b) changing dietary supplement usage patterns. To test this hypothesis, an innovative consumer information delivery system, referred to as the Buyer Information Network (BuyIN), was utilized. BuyIN uses currently available, Web-enabled point-of-sale (POS) technology to provide up-to-date, evidence-based, health- and safety-related messages to consumers at the retail checkout counter. Results showed that more than one-fourth (27.1%) of consumers (n = 199) who purchased targeted items reported they were aware of the messages. Of this subgroup of aware consumers, 11.2% reported that they sought additional information from a physician or pharmacist, 11.5% reported that they visited the website listed on the coupon, and 10.5% indicated that they changed their dietary supplement usage patterns as a result of the messages. Future research should include a large-scale study of a fully implemented and capable system at multiple test sites around the country, including investigating the utility of BuyIN in different retail settings. PMID:23356591

Effect of Vitamin D Supplementation on Pain: A Systematic Review and Meta-analysis.

PubMed

Wu, Zhenqiang; Malihi, Zarintaj; Stewart, Alistair W; Lawes, Carlene Mm; Scragg, Robert

2016-01-01

There is conflicting evidence from previous qualitative reviews on the effect of vitamin D supplementation on pain. To determine with quantitative methods if vitamin D supplementation lowers pain levels. Quantitative meta-analysis of published randomized controlled trials (RCTs). This meta-analysis examined all studies involving the effect of vitamin D supplementation on pain score. Electronic sources (Medline, Embase, Cochrane Central Register of Controlled Trials, clinical trials website, and Google scholar) were systematically searched for RCTs of vitamin D supplementation and pain from inception of each database to October 2015. Nineteen RCTs with 3,436 participants (1,780 on vitamin D supplementation and 1,656 on placebo) were included in the meta-analysis. For the primary outcome (mean change in pain score from baseline to final follow-up), 8 trials with 1,222 participants on vitamin D and 1,235 on placebo reported a significantly greater mean decrease in pain score for the vitamin D group compared to placebo (mean difference -0.57, 95% CI: -1.00 to -0.15, P = 0.007). The effect from vitamin D was greater in patients recruited with pre-existing pain (P-value for interaction = 0.03). Fourteen studies (1,548 on vitamin D, 1,430 on placebo) reported the mean pain score at final follow-up outcome, and no statistical difference was observed (mean difference -0.06, 95%CI: -0.44 to 0.33, P = 0.78). In 4 studies which reported pain improvement (209 on vitamin D, 146 on placebo), the effect size although not significant, shows participants in the vitamin D supplementation group were more likely to report pain improvement compared with the placebo group (relative risk 1.38, 95%CI: 0.93 to 2.05, P = 0.11). Only a few studies reported the mean score change from baseline to final follow-up, and we do not have enough data to determine any modifying effect of baseline vitamin D status and different doses of vitamin D supplementation on pain. A significantly greater mean

Parenteral or Enteral Arginine Supplementation Safety and Efficacy.

PubMed

Rosenthal, Martin D; Carrott, Phillip W; Patel, Jayshil; Kiraly, Laszlo; Martindale, Robert G

2016-12-01

Arginine supplementation has the potential to improve the health of patients. Its use in hospitalized patients has been a controversial topic in the nutrition literature, especially concerning supplementation of septic patients. In this article, we review the relevant literature both for and against the use of arginine in critically ill, surgical, and hospitalized patients. The effect of critical illness on arginine metabolism is reviewed, as is its use in septic and critically ill patients. Although mounting evidence supports immunonutrition, there are only a few studies that suggest that this is safe in patients with severe sepsis. The use of arginine has been shown to benefit a variety of critically ill patients. It should be considered for inclusion in combinations of immunonutrients or commercial formulations for groups in whom its benefit has been reported consistently, such as those who have suffered trauma and those in acute surgical settings. The aims of this review are to discuss the role of arginine in health, the controversy surrounding arginine supplementation of septic patients, and the use of arginine in critically ill patients. © 2016 American Society for Nutrition.

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 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 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...

A Synthetic Vision Preliminary Integrated Safety Analysis

NASA Technical Reports Server (NTRS)

Hemm, Robert; Houser, Scott

2001-01-01

This report documents efforts to analyze a sample of aviation safety programs, using the LMI-developed integrated safety analysis tool to determine the change in system risk resulting from Aviation Safety Program (AvSP) technology implementation. Specifically, we have worked to modify existing system safety tools to address the safety impact of synthetic vision (SV) technology. Safety metrics include reliability, availability, and resultant hazard. This analysis of SV technology is intended to be part of a larger effort to develop a model that is capable of "providing further support to the product design and development team as additional information becomes available". The reliability analysis portion of the effort is complete and is fully documented in this report. The simulation analysis is still underway; it will be documented in a subsequent report. The specific goal of this effort is to apply the integrated safety analysis to SV technology. This report also contains a brief discussion of data necessary to expand the human performance capability of the model, as well as a discussion of human behavior and its implications for system risk assessment in this modeling environment.

Acute and chronic safety and efficacy of dose dependent creatine nitrate supplementation and exercise performance.

PubMed

Galvan, Elfego; Walker, Dillon K; Simbo, Sunday Y; Dalton, Ryan; Levers, Kyle; O'Connor, Abigail; Goodenough, Chelsea; Barringer, Nicholas D; Greenwood, Mike; Rasmussen, Christopher; Smith, Stephen B; Riechman, Steven E; Fluckey, James D; Murano, Peter S; Earnest, Conrad P; Kreider, Richard B

2016-01-01

Creatine monohydrate (CrM) and nitrate are popular supplements for improving exercise performance; yet have not been investigated in combination. We performed two studies to determine the safety and exercise performance-characteristics of creatine nitrate (CrN) supplementation. Study 1 participants (N = 13) ingested 1.5 g CrN (CrN-Low), 3 g CrN (CrN-High), 5 g CrM or a placebo in a randomized, crossover study (7d washout) to determine supplement safety (hepatorenal and muscle enzymes, heart rate, blood pressure and side effects) measured at time-0 (unsupplemented), 30-min, and then hourly for 5-h post-ingestion. Study 2 participants (N = 48) received the same CrN treatments vs. 3 g CrM in a randomized, double-blind, 28d trial inclusive of a 7-d interim testing period and loading sequence (4 servings/d). Day-7 and d-28 measured Tendo™ bench press performance, Wingate testing and a 6x6-s bicycle ergometer sprint. Data were analyzed using a GLM and results are reported as mean ± SD or mean change ± 95 % CI. In both studies we observed several significant, yet stochastic changes in blood markers that were not indicative of potential harm or consistent for any treatment group. Equally, all treatment groups reported a similar number of minimal side effects. In Study 2, there was a significant increase in plasma nitrates for both CrN groups by d-7, subsequently abating by d-28. Muscle creatine increased significantly by d-7 in the CrM and CrN-High groups, but then decreased by d-28 for CrN-High. By d-28, there were significant increases in bench press lifting volume (kg) for all groups (PLA, 126.6, 95 % CI 26.3, 226.8; CrM, 194.1, 95 % CI 89.0, 299.2; CrN-Low, 118.3, 95 % CI 26.1, 210.5; CrN-High, 267.2, 95 % CI 175.0, 359.4, kg). Only the CrN-High group was significantly greater than PLA (p < 0.05). Similar findings were observed for bench press peak power (PLA, 59.0, 95 % CI 4.5, 113.4; CrM, 68.6, 95 % CI 11.4, 125.8; CrN-Low, 40.9, 95

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.

Weight Loss Supplements: Boon or Bane?

PubMed Central

Ansari, Reshma Mohamed; Omar, Norfaizatul Shalida

2017-01-01

Dietary health supplements for weight loss seem to be the future nowadays. However, this industry is plagued by lack of regulations and ignorance regarding the constituents of the supplements. Of all the supplements consumed, the ones for weight loss are most commonly found in the market. Reports of liver failure, kidney impairment and worsening of chronic ailments in patients who consume these supplements are surfacing recently which make us question the credibility of these products. The safety of these products lie in the clear stating of the ingredients by the manufacturer, well informed patient, knowledgeable physician and tight regulations from the regulatory board. PMID:28814927

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

Effect of restricted protein diet supplemented with keto analogues in end-stage renal disease: a systematic review and meta-analysis.

PubMed

Jiang, Zheng; Tang, Yi; Yang, Lichuan; Mi, Xuhua; Qin, Wei

2018-04-01

To evaluate the efficacy and safety of the restricted protein diet supplemented with keto analogues when applied in end-stage renal disease (ESRD). The Cochrane Library, PubMed, Embase, CBM and CENTRAL databases were searched and reviewed up to January 2017. Clinical trials were analyzed using RevMan 5.3 software. Five randomized controlled trials were selected and included in this study according to our inclusion and exclusion criteria. Changes in serum albumin, PTH, triglyceride, cholesterol, calcium, phosphorus, hemoglobin, Kt/v and CRP before and after treatment were analyzed. Meta-analysis results indicated that, compared with normal protein diet, low-protein diet (LPD) supplemented with keto analogues (sLPD) could improve serum albumin (P < 0.00001), hyperparathyroidism (P < 0.00001) and hyperphosphatemia (P = 0.008). No differences in triglyceride, cholesterol, hemoglobin, Kt/v and CRP were observed between different protein intake groups. Restricted protein diet supplemented with keto analogues (sLPD) may improve nutritional status and prevent hyperparathyroidism in ESRD patients. The current data were mainly obtained from short-term, single-center trails with small sample sizes and limited nutritional status indexes, indicating a need for further study.

Safety and Health Benefits of Novel Dietary Supplements Consisting Multiple Phytochemicals, Vitamins, Minerals and Essential Fatty Acids in High Fat Diet Fed Rats.

PubMed

Ramprasath, Vanu Ramkumar; Jones, Peter J H

2016-01-01

The objective was to determine safety and efficacy of health supplements "Beyond Tangy Tangerine," a multivitamin/mineral complex and combination of multivitamin/mineral complex, "Osteofx," a bone healthy supplement and "Ultimate Essential Fatty Acids" in Sprague Dawley rats consuming high-fat diets. Initially a pilot study was conducted which confirmed palatability and acceptability of supplements. In a second study, rats (n = 15/group) were randomized to Control; Multivitamin/mineral complex (2 g/kg BW) or Combination (2 g Multivitamin/mineral complex, 1.5 g Bone healthy supplement and 0.34 g Essential fatty acids/kg BW). No differences were observed in BW change, feed intake, organ weights or bone mineral composition with supplementations compared to control. Multivitamin/mineral complex supplementation decreased abdominal white adipose tissue weights (WAT) (p = .005), total (p = .033) and fat mass (p = .040), plasma IL-6 (p = .016) and ALKP (p = .038) and elevated plasma calcium (p < .001), phosphorus (p = .038), total protein (p = .002), albumin (p = .014) and globulin (p = .018), compared to control. Similarly, combination supplementation reduced WAT (p < .001), total (p = .023) and fat mass (p = .045), plasma triglycerides (p = .018), IL-6 (p = .002) and ALKP (p < .001) with increases in plasma calcium (p = .031), phosphorus (p < .001) compared to control. Results indicate that consuming either supplement can be considered safe and improves overall health by reducing inflammation, abdominal fat mass and plasma triglycerides, as well as promote bone health.

Data Call Response for NEPA Supplement Analysis of CMRR

DOE Office of Scientific and Technical Information (OSTI.GOV)

Booth, Steven Richard

The Department of Energy/National Nuclear Security Administration (DOE/NNSA) is proposing to provide analytical chemistry (AC) and materials characterization (MC) capabilities at the Los Alamos National Laboratory (LANL) by using a combination of existing space in two existing buildings: the Radiological Laboratory/Utility/Office Building (RLUOB) and the Plutonium Facility, Building 4 (PF-4) in TA-55. This represents a change from decisions made by DOE as informed by previous National Environmental Policy Act (NEPA) analyses. In accordance with Council on Environmental Quality (CEQ) and DOE requirements, NNSA is preparing a Supplement Analysis (SA) to evaluate the potential environmental impacts of the proposed action. Themore » focus of this analysis is on determining whether the proposal to provide AC and MC laboratory capabilities in existing space in RLUOB and PF-4 rather than building a new nuclear facility (NF) is a substantial change that is relevant to environmental concerns or whether new circumstance or information relevant to environmental concerns and bearing on the proposed action or its impacts are significant. The end result of the analysis is a determination whether the existing Chemistry and Metallurgy Research Building Replacement Environmental Impact Statement (CMRR EIS) should be supplemented, a new EIS should be prepared, or no further NEPA analysis is necessary. This report provides data for incorporation into the Supplement Analysis being written by Leidos, Inc. under contract to NNSA. Responding to the data call requires several areas of expertise. Los Alamos subject matter experts estimate equipments lists, facility modifications, waste quantities, labor needs and radiological doses. Los Alamos NEPA experts assist Leidos in compiling existing data from the LANL Site-Wide Environmental Impact Statement (SWEIS) and CMRR EIS for public and other impacts. Bounding conditions are used to determine NEPA estimates.« less

Confidence in the efficacy and safety of dietary supplements among United States active duty army personnel

PubMed Central

2012-01-01

Background United States Army Soldiers regularly use dietary supplements (DS) to promote general health, enhance muscle strength, and increase energy, but limited scientific evidence supports the use of many DS for these benefits. This study investigated factors associated with Soldiers’ confidence in the efficacy and safety of DS, and assessed Soldiers’ knowledge of federal DS regulatory requirements. Methods Between 2006 and 2007, 990 Soldiers were surveyed at 11 Army bases world-wide to assess their confidence in the effectiveness and safety of DS, knowledge of federal DS regulations, demographic characteristics, lifestyle-behaviors and DS use. Results A majority of Soldiers were at least somewhat confident that DS work as advertised (67%) and thought they are safe to consume (71%). Confidence in both attributes was higher among regular DS users than non-users. Among users, confidence in both attributes was positively associated with rank, self-rated diet quality and fitness level, education, and having never experienced an apparent DS-related adverse event. Fewer than half of Soldiers knew the government does not require manufacturers to demonstrate efficacy, and almost a third incorrectly believed there are effective pre-market federal safety requirements for DS. Conclusions Despite limited scientific evidence supporting the purported benefits and safety of many popular DS, most Soldiers were confident that DS are effective and safe. The positive associations between confidence and DS use should be considered when developing DS-related interventions or policies. Additionally, education to clarify Soldiers’ misperceptions about federal DS safety and efficacy regulations is warranted. PMID:23051046

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

49 CFR 229.307 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 4 2012-10-01 2012-10-01 false Safety analysis. 229.307 Section 229.307 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Locomotive Electronics § 229.307 Safety...

Safety, Health, and Fire Prevention Guide for Hospital Safety Managers

DTIC Science & Technology

1993-03-01

Safety committee S 2-5 Oxygen quality assurance program 0 2-6 Safety and fire prevention library 0 2-7 Safety services to Dental Activities • 2-8...Chapter 2 Safety Management 2-1. Safety policy statement Health Services Command (HSC) Supplement (Suppl) 1 to Army Regulation (AR) 385-10 and the...Management. (b) The medical staff. (c) The nursing service . (d) Logistics. (e) Nutritional care. (f) Preventive medicine. * 2-3 USAEHA TG No. 152 March 1993 (g

10 CFR 830.206 - Preliminary documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Preliminary documented safety analysis. 830.206 Section 830.206 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.206 Preliminary documented safety analysis. If construction begins after December 11, 2000, the contractor...

Deep Borehole Disposal Safety Analysis.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

Effect of restricted protein diet supplemented with keto analogues in chronic kidney disease: a systematic review and meta-analysis.

PubMed

Jiang, Zheng; Zhang, Xiaoyan; Yang, Lichuan; Li, Zi; Qin, Wei

2016-03-01

To evaluate the efficacy and safety of the restricted protein diet (low or very low protein diet) supplemented with keto analogues in the treatment of chronic kidney disease (CKD). The Cochrane library, PubMed, Embase, CBM and CENTRAL databases were searched and reviewed up to April 2015. Clinical trials were analyzed using RevMan 5.3 software. Seven random control trials, one cross-over trial and one non-randomized concurrent control trial were selected and included in this study according to our inclusion and exclusion criteria. The changes of eGFR, BUN, Scr, albumin, PTH, triglyceride, cholesterol, calcium, phosphorus and nutrition indexes (BMI, lean body mass and mid-arm muscular circumference) before and after treatment were analyzed. The meta-analysis results indicated that, comparing with normal protein diet, low protein diet (LPD) or very low protein diet (vLPD) supplemented with keto analogues (s(v)LPD) could significantly prevent the deterioration of eGFR (P < 0.001), hyperparathyroidism (P = 0.04), hypertension (P < 0.01) and hyperphosphatemia (P < 0.001). No differences in BUN, Scr, Albumin, triglyceride, cholesterol, hemoglobin, calcium and nutrition indexes were observed between different protein intake groups. Restricted protein diet supplemented with keto analogues (s(v)LPD) could delay the progression of CKD effectively without causing malnutrition.

Effects of a Pre-workout Supplement on Lean Mass, Muscular Performance, Subjective Workout Experience and Biomarkers of Safety

PubMed Central

Kedia, A. William; Hofheins, Jennifer E.; Habowski, Scott M.; Ferrando, Arny A.; Gothard, M. David; Lopez, Hector L.

2014-01-01

In this prospective, randomized, double-blind, trial conducted in two parts, we examined the effects of a multi-ingredient pre-exercise workout supplement blend of creatine, betaine and a dendrobium extract (MMP) on safety, performance, and body composition in healthy men and women undergoing a supervised program of resistance exercise. Part 1 was an acute hemodynamic safety study wherein forty young, healthy men and women (26.2 ± 5.3 years, 70.4 ± 3.3 inches, 83.7 ± 14.9 kg, 26.0 ± 3.2 kg●m-2) ingest one dose of either the MMP or comparator in a randomized, double-blind, comparator controlled, crossover fashion before having their resting heart rate, blood, ECG and comprehensive blood chemistry and blood counts completed. Systolic (SBP) and diastolic (DBP) blood pressures were generally raised (3.0-5.4 mm Hg, p<0.01) following supplementation with MPP whereas in the comparator group SBP was marginally reduced by 0.3 to 1.2 mm Hg, p>0.05 at all time points) and DBP was increased (3.0 - 3.9 mm Hg, p<0.05 at all time points). No changes in EKG-corrected QT interval were observed, and no serious adverse events were reported. Part 2 was a six-week training study wherein forty-three young, healthy men and women (24.3 ± 2.9 years, 70.5 ± 3.1 inches, 83.8 ± 9.6 kg, 26.1 ± 2.7 kg●m-2) supplemented with daily pre-workout doses of either the MPP or a comparator in a randomized, double-blind, comparator-controlled fashion while following a standardized resistance training program for six weeks. MPP and the comparator were isocaloric and delivered the same amount of caffeine. Significant improvements in visual analog scale (VAS) scores for energy (p<0.024) and concentration (p<0.041) were found along with consistently higher levels of focus accompanied by less fatigue when MPP was consumed in comparison to comparator during upper body muscular strength-endurance tests at weeks 3 and 6. MPP supplementation for 6 weeks did not improve dual-energy x-ray absorptiometry

Effects of a pre-workout supplement on lean mass, muscular performance, subjective workout experience and biomarkers of safety.

PubMed

Kedia, A William; Hofheins, Jennifer E; Habowski, Scott M; Ferrando, Arny A; Gothard, M David; Lopez, Hector L

2014-01-01

In this prospective, randomized, double-blind, trial conducted in two parts, we examined the effects of a multi-ingredient pre-exercise workout supplement blend of creatine, betaine and a dendrobium extract (MMP) on safety, performance, and body composition in healthy men and women undergoing a supervised program of resistance exercise. Part 1 was an acute hemodynamic safety study wherein forty young, healthy men and women (26.2 ± 5.3 years, 70.4 ± 3.3 inches, 83.7 ± 14.9 kg, 26.0 ± 3.2 kg●m(-2)) ingest one dose of either the MMP or comparator in a randomized, double-blind, comparator controlled, crossover fashion before having their resting heart rate, blood, ECG and comprehensive blood chemistry and blood counts completed. Systolic (SBP) and diastolic (DBP) blood pressures were generally raised (3.0-5.4 mm Hg, p<0.01) following supplementation with MPP whereas in the comparator group SBP was marginally reduced by 0.3 to 1.2 mm Hg, p>0.05 at all time points) and DBP was increased (3.0 - 3.9 mm Hg, p<0.05 at all time points). No changes in EKG-corrected QT interval were observed, and no serious adverse events were reported. Part 2 was a six-week training study wherein forty-three young, healthy men and women (24.3 ± 2.9 years, 70.5 ± 3.1 inches, 83.8 ± 9.6 kg, 26.1 ± 2.7 kg●m(-2)) supplemented with daily pre-workout doses of either the MPP or a comparator in a randomized, double-blind, comparator-controlled fashion while following a standardized resistance training program for six weeks. MPP and the comparator were isocaloric and delivered the same amount of caffeine. Significant improvements in visual analog scale (VAS) scores for energy (p<0.024) and concentration (p<0.041) were found along with consistently higher levels of focus accompanied by less fatigue when MPP was consumed in comparison to comparator during upper body muscular strength-endurance tests at weeks 3 and 6. MPP supplementation for 6 weeks did not improve dual-energy x

System safety engineering analysis handbook

NASA Technical Reports Server (NTRS)

Ijams, T. E.

1972-01-01

The basic requirements and guidelines for the preparation of System Safety Engineering Analysis are presented. The philosophy of System Safety and the various analytic methods available to the engineering profession are discussed. A text-book description of each of the methods is included.

Commercially marketed supplements for bodybuilding athletes.

PubMed

Grunewald, K K; Bailey, R S

1993-02-01

We conducted a survey of 624 commercially available supplements targeted towards bodybuilding athletes. Over 800 performance claims were made for these supplements. Supplements include amino acids, boron, carnitine, choline, chromium, dibencozide, ferulic acid, gamma oryzanol, medium chain triglycerides, weight gain powders, Smilax compounds and yohimbine. Many performance claims advertised were not supported by published research studies. In some instances, we found no research to validate the claims; in other cases, research findings were extrapolated to inappropriate applications. For example, biological functions of some non-essential compounds were interpreted as performance claims for the supplements. Claims for others were based on their ability to enhance hormonal release or activity. We suggest that more research be conducted on this group of athletes and their nutritional needs. Furthermore, the effectiveness and safety of supplements merit further investigation.

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.

Updated cost-effectiveness analysis of supplemental glutamine for parenteral nutrition of intensive-care patients

PubMed Central

Pradelli, L; Povero, M; Muscaritoli, M; Eandi, M

2015-01-01

Background/Objectives: Intravenous (i.v.) glutamine supplementation of parenteral nutrition (PN) can improve clinical outcomes, reduce mortality and infection rates and shorten the length of hospital and/or intensive care unit (ICU) stays compared with standard PN. This study is a pharmacoeconomic analysis to determine whether i.v. glutamine supplementation of PN remains both a highly favourable and cost-effective option for Italian ICU patients. Subjects/Methods: A previously published discrete event simulation model was updated by incorporating the most up-to-date and clinically relevant efficacy data (a clinically realistic subgroup analysis from a published meta-analysis), recent cost data from the Italian health-care system and the latest epidemiology data from a large Italian ICU database (covering 230 Italian ICUs and more than 77 000 patients). Sensitivity analyses were performed to test the robustness of the results. Results: Parenteral glutamine supplementation can significantly improve ICU efficiency in Italy, as the additional cost of supplemented treatment is more than completely offset by cost savings in hospital care. Supplementation was more cost-effective (cost-effectiveness ratio (CER)=€35 165 per patient discharged alive) than standard, non-supplemented PN (CER=€40 156 per patient discharged alive), and it resulted in mean cost savings of €4991 per patient discharged alive or €1047 per patient admitted to the hospital. Sensitivity analyses confirmed the robustness of these results. Conclusions: Alanyl-glutamine supplementation of PN is a clinically and economically attractive strategy for ICU patients in Italy and may be applicable to selected ICU patient populations in other countries. PMID:25469466

Updated cost-effectiveness analysis of supplemental glutamine for parenteral nutrition of intensive-care patients.

PubMed

Pradelli, L; Povero, M; Muscaritoli, M; Eandi, M

2015-05-01

Intravenous (i.v.) glutamine supplementation of parenteral nutrition (PN) can improve clinical outcomes, reduce mortality and infection rates and shorten the length of hospital and/or intensive care unit (ICU) stays compared with standard PN. This study is a pharmacoeconomic analysis to determine whether i.v. glutamine supplementation of PN remains both a highly favourable and cost-effective option for Italian ICU patients. A previously published discrete event simulation model was updated by incorporating the most up-to-date and clinically relevant efficacy data (a clinically realistic subgroup analysis from a published meta-analysis), recent cost data from the Italian health-care system and the latest epidemiology data from a large Italian ICU database (covering 230 Italian ICUs and more than 77,000 patients). Sensitivity analyses were performed to test the robustness of the results. Parenteral glutamine supplementation can significantly improve ICU efficiency in Italy, as the additional cost of supplemented treatment is more than completely offset by cost savings in hospital care. Supplementation was more cost-effective (cost-effectiveness ratio (CER)=[euro ]35,165 per patient discharged alive) than standard, non-supplemented PN (CER=[euro ]40,156 per patient discharged alive), and it resulted in mean cost savings of [euro ]4991 per patient discharged alive or [euro ]1047 per patient admitted to the hospital. Sensitivity analyses confirmed the robustness of these results. Alanyl-glutamine supplementation of PN is a clinically and economically attractive strategy for ICU patients in Italy and may be applicable to selected ICU patient populations in other countries.

Randomized controlled trial to determine the effectiveness of an interactive multimedia food safety education program for clients of the special supplemental nutrition program for women, infants, and children.

PubMed

Trepka, Mary Jo; Newman, Frederick L; Davila, Evelyn P; Matthew, Karen J; Dixon, Zisca; Huffman, Fatma G

2008-06-01

Pregnant women and the very young are among those most susceptible to foodborne infections and at high risk of a severe outcome from foodborne infections. To determine if interactive multimedia is a more effective method than pamphlets for delivering food safety education to Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients. A randomized controlled trial of WIC clients was conducted. Self-reported food safety practices were compared between pre- and postintervention questionnaires completed >or=2 months after the intervention. Pregnant WIC clients or female caregivers (usually mothers) of WIC clients who were 18 years of age or older and able to speak and read English were recruited from an inner-city WIC clinic. Participants were randomized to receive food safety pamphlets or complete an interactive multimedia food safety education program on a computer kiosk. Change from pre- to postintervention food safety scores. A mean food safety score was determined for each participant for the pre- and postintervention questionnaires. The scores were used in a two-group repeated measures analysis of variance. Of the 394 participants, 255 (64.7%) completed the postintervention questionnaire. Satisfaction with the program was high especially among those with no education beyond high school. When considering a repeated measures analysis of variance model with the two fixed between-subject effects of group and age, a larger improvement in score in the interactive multimedia group than in the pamphlet group (P=0.005) was found, but the size of the group effect was small (partial eta(2)=0.033). Women aged 35 years or older in the interactive multimedia group had the largest increase in score. The interactive multimedia was well-accepted and resulted in improved self-reported food safety practices, suggesting that interactive multimedia is an effective option for food safety education in WIC clinics.

The Public Health Impact of Herbs and Nutritional Supplements.

PubMed

Cassileth, Barrie R; Heitzer, Marjet; Wesa, Kathleen

2009-08-01

Dietary supplement use has increased exponentially in recent years despite the lack of regulatory oversight and in the face of growing safety concerns. This paper provides an overview of the public health implications and safety concerns associated with dietary supplement use, especially by cancer patients. Botanical research is actively pursued at the Memorial Sloan-Kettering Cancer Center (MSKCC) Integrative Medicine department. Work of the MSKCC Center for the Study of Botanical Immunomodulators is described, and guidelines for cancer patients' use of dietary supplements outlined. Herbs and other botanicals are complex, physiologically active agents, but little is known about most of the popular, widely available dietary supplements. Herb-drug interactions, a major concern, are exacerbated in the cancer setting. Biologically active agents may interfere with chemotherapy and other prescription medications. They may exert anti-coagulant activity at rather inconvenient times such as during surgery, and create other serious problems. Research on the bioavailability, effective dosage, safety and benefits of these complex agents is sorely needed. Oncology professionals and other healthcare providers should educate themselves and their patients about these issues. Probably the largest, continuously-updated free information resource is MSKCC's AboutHerbs website (www.mskcc.org/AboutHerbs).

Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

MedlinePlus

... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

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

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study

PubMed Central

Anton, Stephen D.; Embry, Chelsea; Marsiske, Michael; Lud, Xiaomin; Doss, Hani; Leeuwenburgh, Christiaan; Manini, Todd M.

2014-01-01

Resveratrol has been found to have potent antioxidant, anti-inflammatory, and anticarcinogenic effects. The safety and efficacy of resveratrol supplementation in older adults are currently unknown. We conducted a double-blind, randomized, placebo-controlled trial to examine the safety and metabolic outcomes in 32 overweight, older adults (mean age, 73 ± 7 years). Participants were randomized into one of three treatment groups: (1) placebo, (2) moderate dose resveratrol (300 mg/day), and (3) high dose resveratrol (1000 mg/day). Both resveratrol and placebo were orally ingested in capsule form twice daily for 90 days. Blood chemistry values remained within the normal range, and there were no significant differences in the number of participants reporting adverse events across conditions. Compared to placebo, glucose levels were significantly lower at post-treatment among participants randomized to both resveratrol conditions, with and without adjustment for the corresponding baseline values (ps < 0.05). Glucose values of participants in the treatment groups, however, were not significantly different from baseline levels. These findings suggest that short-term resveratrol supplementation at doses of 300 mg/day and 1000 mg/day does not adversely affect blood chemistries and is well tolerated in overweight, older individuals. These findings support the study of resveratrol for improving cardio-metabolic health in older adults in larger clinical trials. PMID:24866496

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

Cost analysis of Omega-3 supplementation in critically ill patients with sepsis.

PubMed

Kyeremanteng, Kwadwo; Shen, Jennifer; Thavorn, Kednapa; Fernando, Shannon M; Herritt, Brent; Chaudhuri, Dipayan; Tanuseputro, Peter

2018-06-01

Nutritional supplement of omega-3 fatty acids have been proposed to improve clinical outcomes in critically ill patients. While previous work have demonstrated that omega-3 supplementation in patients with sepsis is associated with reduced ICU and hospital length of stay, the financial impact of this intervention is unknown. Perform a cost analysis to evaluate the impact of omega-3 supplementation on ICU and hospital costs. We extracted data related to ICU and hospital length of stay from the individual studies reported in a recent systematic review. The Cochrane Collaboration tool was used to assess the risk of bias in these studies. Average daily ICU and hospital costs per patient were obtained from a cost study by Kahn et al. We estimated the ICU and hospital costs by multiplying the mean length of stay by the average daily cost per patient in ICU or Hospital. Adjustments for inflation were made according to the USD annual consumer price index. We calculated the difference between the direct variable cost of patients with omega-3 supplementation and patients without omega-3 supplementation. 95% confidence intervals were estimated using bootstrap re-sampling procedures with 1000 iterations. A total of 12 RCT involving 925 patients were included in this cost analysis. Septic patients supplemented with omega-3 had both lower mean ICU costs ($15,274 vs. $18,172) resulting in $2897 in ICU savings per patient and overall hospital costs ($17,088 vs. $19,778), resulting in $2690 in hospital savings per patient. Sensitivity analyses were conducted to investigate the impact of different study methods on the LOS. The results were still consistent with the overall findings. Patients with sepsis who received omega-3 supplementation had significantly shorter LOS in the ICU and hospital, and were associated with lower direct variable costs than control patients. The 12 RCTs used in this analysis had a high risk of bias. Large-scaled, high-quality, multi-centered RCTs on the

SRB Safety Analysis

NASA Image and Video Library

2003-09-11

Jeff Thon, an SRB mechanic with United Space Alliance, is lowered into a mockup of a segment of a solid rocket booster. He is testing a technique for vertical SRB propellant grain inspection. The inspection of segments is required as part of safety analysis.

Infusing Reliability Techniques into Software Safety Analysis

NASA Technical Reports Server (NTRS)

Shi, Ying

2015-01-01

Software safety analysis for a large software intensive system is always a challenge. Software safety practitioners need to ensure that software related hazards are completely identified, controlled, and tracked. This paper discusses in detail how to incorporate the traditional reliability techniques into the entire software safety analysis process. In addition, this paper addresses how information can be effectively shared between the various practitioners involved in the software safety analyses. The author has successfully applied the approach to several aerospace applications. Examples are provided to illustrate the key steps of the proposed approach.

The incidence of vitamin, mineral, herbal, and other supplement use in facial cosmetic patients.

PubMed

Zwiebel, Samantha J; Lee, Michelle; Alleyne, Brendan; Guyuron, Bahman

2013-07-01

Dietary supplement use is common in the United States. Some herbal supplements may cause coagulopathy, hypertension, or dry eyes. The goal of this study is to reveal the incidence of herbal supplement use in the cosmetic surgery population. A retrospective chart review of 200 patients undergoing facial cosmetic surgery performed by a single surgeon was performed. Variables studied included patient age, sex, surgical procedure, herbal medication use, and intraoperative variables. Exclusion criteria were age younger than 15 years, noncosmetic procedures such as trauma, and incomplete preoperative medication form. Patients were subdivided into the supplement user group (herbal) and the supplement nonuser group (nonherbal). Statistical analysis included descriptive statistics, t test, and chi-square analysis. The incidence of supplement use was 49 percent in the 200 patients; 24.5 percent of patients used only vitamins or minerals, 2.5 percent of patients used only animal- and plant-based (nonvitamin/mineral) supplements, and 22 percent of patients used both types of supplements. In the herbal group, patients used an average of 2.8 supplements. The herbal and nonherbal groups differed significantly in sex (herbal, 89.8 percent female; nonherbal, 77.5 percent; p < 0.04) and age (herbal, 51.4 years; nonherbal, 38.5 years; p < 0.001). Herbal supplement use is prevalent in the facial cosmetic surgery population, especially in the older female population. Considering the potential ill effects of these products on surgery and recovery, awareness and careful documentation and prohibiting the patients from the consumption of these products will increase the safety and reduce the recovery following cosmetic procedures.

Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial.

PubMed

Shen, Chwan-Li; Mo, Huanbiao; Yang, Shengping; Wang, Shu; Felton, Carol K; Tomison, Michael D; Soelaiman, Ima Nirwana

2016-12-23

Osteoporosis is a major health concern in postmenopausal women, and oxidative stress contributes to the development of bone loss. Cellular studies and ovariectomised rat model mimicking bone loss in postmenopausal women show the bone-protective effect of tocotrienols (TTs) with antioxidant capability. We aim to access the safety and efficacy of TT consumption for bone health in postmenopausal women. In this 12-week randomised double-blinded placebo-controlled trial for the effects of dietary TT supplementation in postmenopausal women, postmenopausal women aged 45 years and older with at least 1 year after menopause and bone mineral density T-score at the spine and/or hip 2.5 or more below the reference values will be randomly assigned to 3 daily supplements: (1) placebo group receiving 860 mg olive oil, (2) low TT group receiving 430 mg of 70% pure TTs (containing 300 mg TT) and (3) high TT group receiving 860 mg of 70% pure TTs (600 mg TT). The primary outcome measure will be urinary N-terminal telopeptide. The secondary outcome measures will be serum bone-specific alkaline phosphatase, receptor activator of nuclear factor-κB ligand, osteoprotegerin, urinary 8-hydroxy-2'-deoxyguanosine and quality of life. At 0, 6 and 12 weeks, the following will be assessed: (1) primary and secondary outcome measures; (2) serum TT and tocopherol concentrations; (3) physical activity and food frequency questionnaires. Liver function will be monitored every 6 weeks for safety. 'Intent-to-treat' principle will be employed for data analysis. A model of repeated measurements with random effect error terms will be applied. Analysis of covariance, χ 2 analysis and regression will be used for comparisons. This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center. The findings of this trial will be submitted to a peer-reviewed journal in the areas of bone or nutrition and international conferences. NCT02058420; results

Herbal Supplements for Prostate Enlargement: Current State of the Evidence.

PubMed

Nabavizadeh, Reza; Zangi, Mahdi; Kim, Michelle M; Yavari Bejestani, Maryam; Tabatabaei, Shahin

2018-02-01

To provide a comprehensive review of the current state of herbal supplement market for lower urinary tract symptoms (LUTS) and correlate the ingredients of each product with available scientific evidence. Twenty-seven products from Amazon.com that were advertised as herbal supplements for LUTS and had listed their active ingredients were selected. Active ingredients were reviewed on Google Scholar. Product price, warranty, and consumer review information were also collected. A total of 58 unique active ingredients were identified. The mean number of ingredients was 8.26 (standard deviation 5.25). Whereas 17 (63%) products had an ingredient with a systematic review to support their use, 20 (74%) had an ingredient with conflicting evidence based on systematic reviews. Out of the supplements that contained ingredients supported by literature, all (100%) products simultaneously had other ingredients with no, conflicting, or refuting evidence. There was no (0%) product that contained only scientifically proven ingredients. There is no scientific study to evaluate these supplements as a whole. Despite the widespread use of herbal supplements for LUTS, there is scant scientific evidence to support their safety and efficacy. Lack of adequate regulation and government support for research and development are some of the factors that disincentivize researchers to study safety and efficacy of these products. We encourage physicians to warn their patients on the lack of adequate evidence to support the safety and efficacy of many of these supplements. Copyright © 2017 Elsevier Inc. All rights reserved.

Social Media Listening for Routine Post-Marketing Safety Surveillance.

PubMed

Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

2016-05-01

Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

Vitamin D Supplementation, Glycemic Control, and Insulin Resistance in Prediabetics: A Meta-Analysis

PubMed Central

Mirhosseini, Naghmeh; Vatanparast, Hassanali; Mazidi, Mohsen; Kimball, Samantha M

2018-01-01

Abstract Diabetes prevention is a public health priority. Vitamin D supplementation may help prevent the development of diabetes in persons at increased risk. We performed a meta-analysis of controlled clinical trials that assessed glycemic outcome measures among adults at risk for type 2 diabetes, including prediabetes, overweight, or obesity. We searched PUBMED/ MEDLINE, CINAHL, and Google Scholar databases for trials published prior to April 2017. Placebo-controlled clinical trials with random allocation to vitamin D with or without calcium supplementation were selected. Data collection included country, study design, inclusion criteria, sample size, form, and dose of vitamin D, supplementation interval, control group, duration, participant characteristics, comorbidities, baseline and follow-up serum 25-hydroxyvitamin D [25(OH)D] concentration, and available outcome measures [glycosylated hemoglobin (HbA1c), fasting plasma glucose, plasma glucose after 2-hour oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR)]. Data synthesis was conducted using random-effect models (PROSPERO registration no. CRD42017055326). Twenty-eight trials, representing 3848 participants, met the eligibility criteria. Compared with the control group, vitamin D supplementation significantly reduced HbA1c level by –0.48% (95% CI, –0.79 to –0.18), fasting plasma glucose level by –0.46 mmol/L (95% CI, –0.74 to –0.19), and HOMA-IR level by –0.39 (95% CI, –0.68 to –0.11). Subgroup analysis revealed that the effects of vitamin D supplementation on different glycemic measures were influenced by age, calcium coadministration, vitamin D deficiency, serum 25(OH)D level after supplementation, and duration of supplementation. Vitamin D supplementation and improved vitamin D status improved glycemic measures and insulin sensitivity and may be useful as part of a preventive strategy for type 2 diabetes.

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.

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.

Packaging and Transportation Safety

DOT National Transportation Integrated Search

1997-01-31

This Guide supplements the Department of Energy (DOE) Order, DOE O 460.1A, PACKAGING AND TRANSPORTATION SAFETY, 10-2-96, by providing clarifying material for the implementation of packaging and transportation safety of hazardous materials. DOE O 460....

Nutritional supplements and the EU: is anyone happy?

PubMed

Eberhardie, Christine

2007-11-01

In 2000 an estimated pound sterling 335 x 106 was spent on food supplements and herbal remedies in the UK. Until recently, The Trades Description Act 1968, the Food Safety Act 1990 and The Food Labelling Regulations 1996 (amended 2004) were the only form of regulation available to protect the public. The medical community has been concerned about the risk to patients of inaccurate dosages and poor-quality products as well as drug-nutrient and nutrient-nutrient interactions. Following growing concern about the type and quality of food supplements and herbal remedies available in the EU, the European Commission has published directives regulating food supplements (2002/46/EC) and herbal remedies (2004/24/EC and 2004/27/EC) available within the EU. The directives came into force in 2005 and limit the number and quality of permitted food supplements through the creation of a 'positive list' of approved supplements. In the present paper the new regulatory frameworks and the implications for the food supplement manufacturers, traditional and complementary therapists, the healthcare professions and patients will be examined. It would appear that there is considerable dissatisfaction with the regulations in their present form. Several questions remain: is regulation the answer; who decides which nutrients go on the positive list; what effect has the regulation had on patient safety and patient choice?

[Isoflavone-containing dietary supplements].

PubMed

Lehmann, Leane; Soukup, Sebastian T; Gerhäuser, Clarissa; Vollmer, Günter; Kulling, Sabine E

2017-03-01

Isoflavones (IFs) from soy and other legumes have weak estrogenic properties. Isolated IFs are available as dietary supplements and advertised to alleviate symptoms of menopause. The present chapter provides an overview of the occurrence, the chemical structure of IFs and their metabolites, the market situation and reviews the current evidence on the efficacy and safety of IF-containing dietary supplements.The biological effectiveness of IFs is attributable to the activation of the estrogen receptor (ER). Studies on the influence of IFs on endogenous estrogen levels in women show inconsistent results. So far, the European Food Safety Authority (EFSA) has rejected all submitted health claims for IFs due to insufficient scientific evidence for any of the postulated health effects. Based on the results of their recent risk assessment, the EFSA concluded that the available human studies did not support the hypothesis of adverse effects of isolated IFs on the human mammary gland, uterus or thyroid in healthy postmenopausal women. However, the assessment does not allow a general statement on the safety of IF-containing dietary supplements. Studies in animal models are often not comparable with the complex interactions in humans due to differences in the metabolism of IFs, in the developmental stage at time of consumption and in the temporarily restricted uptake of IFs during certain stages of life. So far, for none of the advertised functions is unequivocal scientific evidence available. On the basis of available data, potential unwanted side effects cannot be fully excluded. This holds particularly true for women with undiagnosed diseases, especially for those with undetected precancerous lesions in the mammary gland.

Concept analysis of safety climate in healthcare providers.

PubMed

Lin, Ying-Siou; Lin, Yen-Chun; Lou, Meei-Fang

2017-06-01

To report an analysis of the concept of safety climate in healthcare providers. Compliance with safe work practices is essential to patient safety and care outcomes. Analysing the concept of safety climate from the perspective of healthcare providers could improve understanding of the correlations between safety climate and healthcare provider compliance with safe work practices, thus enhancing quality of patient care. Concept analysis. The electronic databases of CINAHL, MEDLINE, PubMed and Web of Science were searched for literature published between 1995-2015. Searches used the keywords 'safety climate' or 'safety culture' with 'hospital' or 'healthcare'. The concept analysis method of Walker and Avant analysed safety climate from the perspective of healthcare providers. Three attributes defined how healthcare providers define safety climate: (1) creation of safe working environment by senior management in healthcare organisations; (2) shared perception of healthcare providers about safety of their work environment; and (3) the effective dissemination of safety information. Antecedents included the characteristics of healthcare providers and healthcare organisations as a whole, and the types of work in which they are engaged. Consequences consisted of safety performance and safety outcomes. Most studies developed and assessed the survey tools of safety climate or safety culture, with a minority consisting of interventional measures for improving safety climate. More prospective studies are needed to create interventional measures for improving safety climate of healthcare providers. This study is provided as a reference for use in developing multidimensional safety climate assessment tools and interventional measures. The values healthcare teams emphasise with regard to safety can serve to improve safety performance. Having an understanding of the concept of and interventional measures for safety climate allows healthcare providers to ensure the safety of their

Interchange Safety Analysis Tool (ISAT) : user manual

DOT National Transportation Integrated Search

2007-06-01

This User Manual describes the usage and operation of the spreadsheet-based Interchange Safety Analysis Tool (ISAT). ISAT provides design and safety engineers with an automated tool for assessing the safety effects of geometric design and traffic con...

Using cost-effectiveness analysis to evaluate targeting strategies: the case of vitamin A supplementation.

PubMed

Loevinsohn, B P; Sutter, R W; Costales, M O

1997-03-01

Given the demonstrated efficacy of vitamin A supplements in reducing childhood mortality, health officials now have to decide whether it would be efficient to target the supplements to high risk children. Decisions about targeting are complex because they depend on a number of factors; the degree of clustering of preventable deaths, the cost of the intervention, the side-effects of the intervention, the cost of identifying the high risk group, and the accuracy of the 'diagnosis' of risk. A cost-effectiveness analysis was used in the Philippines to examine whether vitamin A supplements should be given universally to all children 6-59 months, targeted broadly to children suffering from mild, moderate, or severe malnutrition, or targeted narrowly to pre-schoolers with moderate and severe malnutrition. The first year average cost of the universal approach was US$67.21 per death averted compared to $144.12 and $257.20 for the broad and narrow targeting approaches respectively. When subjected to sensitivity analysis the conclusion about the most cost-effective strategy was robust to changes in underlying assumptions such as the efficacy of supplements, clustering of deaths, and toxicity. Targeting vitamin A supplements to high risk children is not an efficient use of resources. Based on the results of this cost-effectiveness analysis and a consideration of alternate strategies, it is apparent that vitamin A, like immunization, should be provided to all pre-schoolers in the developing world. Issues about targeting public health interventions can usefully be addressed by cost-effectiveness analysis.

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.

Tips for Older Dietary Supplement Users

MedlinePlus

... by the government for safety or effectiveness before marketing. Also, unlike drugs, supplements are not intended to ... Others: American Dietetic Association American Pharmacists Association Food Marketing Institute International Food Information Council Foundation National Council ...

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".

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... qualified to perform the ground safety analysis through training, education, and experience. (c) A launch... unfenced boundary of an entire industrial complex or multi-user launch site. A launch location hazard may.... (j) A launch operator must verify all information in a ground safety analysis, including design...

The safety and regulation of natural products used as foods and food ingredients.

PubMed

Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

2011-10-01

The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

Efficacy of synbiotic supplementation in patients with nonalcoholic fatty liver disease: A systematic review and meta-analysis of clinical trials: Synbiotic supplementation and NAFLD.

PubMed

Hadi, Amir; Mohammadi, Hamed; Miraghajani, Maryam; Ghaedi, Ehsan

2018-03-27

We systematically reviewed available randomized clinical trials (RCTs) to elucidate the overall effects of synbiotic supplementation in patients with nonalcoholic fatty liver disease (NAFLD). PubMed, Scopus, ISI Web of science and Google Scholar were searched up to December, 2017. All RCTs using synbiotic supplements to treat NAFLD included in this systematic review and meta-analysis. Mean Difference (MD) was pooled using a random-effects model. Eleven eligible databases from seven RCTs were identified for the present meta-analysis. Our results showed that synbiotic supplementation can decrease body weight, fasting blood sugar, insulin, low density lipoprotein cholesterol, total cholesterol, triglyceride, high-sensitivity C-reactive protein, tumor necrosis factor alpha, alanine transaminase and aspartate transaminase levels among patients with NAFLD. In contrast, synbiotic did not have favorable effects on body mass index (BMI), waist circumference, homeostasis model assessment for insulin resistance (HOMA-IR), and high density lipoprotein cholesterol (HDL) levels compared with the placebo group. The current study revealed that synbiotic supplementation has favorable effect on inflammatory factors, liver enzymes and some anthropometric indices, lipid profiles and glucose homeostasis parameters in patients with NAFLD.

Dietary Supplements: Regulatory Challenges and Research Resources.

PubMed

Dwyer, Johanna T; Coates, Paul M; Smith, Michael J

2018-01-04

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

Dietary Supplements: Regulatory Challenges and Research Resources

PubMed Central

Dwyer, Johanna T.; Coates, Paul M.; Smith, Michael J.

2018-01-01

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them. PMID:29300341

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...

Missouri Highway Safety Manual Recalibration

DOT National Transportation Integrated Search

2018-05-01

The Highway Safety Manual (HSM) is a national manual for analyzing the highway safety of various facilities, including rural roads, urban arterials, freeways, and intersections. The HSM was first published in 2010, and a 2014 supplement addressed fre...

Systems Analysis of NASA Aviation Safety Program: Final Report

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.; Withrow, Colleen A.; Evans, Joni K.; Barr, Lawrence; Leone, Karen

2013-01-01

A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

Arsenic speciation and fucoxanthin analysis from seaweed dietary supplements using LC-MS.

PubMed

Avula, Bharathi; Wang, Yan-Hong; Khan, Ikhlas A

2015-01-01

The study involves the analysis of total arsenic (As) in metallic form, and organic and inorganic As species from seaweeds and dietary supplements. The analysis provides data for dietary exposure estimates of inorganic species that are considered more toxic to humans than organic and total As. Total As was determined by acid digestion followed by inductively coupled plasma (ICP)-MS. To characterize the As species, solvent extraction with sonication and microwave extraction using various aqueous and aqueous/organic solvent mixtures were initially evaluated. The optimum As speciation method was determined to be water extraction followed by anion exchange HPLC coupled with ICP-MS. Optimization of chromatographic conditions led to baseline separation for six As species, including As acid, arsenous acid, monomethylarsonic acid, dimethylarsinic acid, arsenobetaine, and arsenocholine, in approximately 8 min using gradient elution. Detection limits for all six compounds were in the range of 10-15 ng/mL. The data presented here will be valuable for the QA of analytical method development and surveys of total As and As species in dietary supplements. The most abundant As species found were arsenite [As(III)] and arsenate [As(V)]. The sum of inorganic As species present in the dietary supplements ranged from 1.2 to 31 μg/day. In addition, the dietary supplements purported to contain fucoxanthin, a carotenoid having pharmacological activities, were analyzed using ultra-performance LC-UV/MS.

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.

32 CFR 651.24 - Supplemental EAs and supplemental EISs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Supplemental EAs and supplemental EISs. 651.24 Section 651.24 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY (CONTINUED) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents § 651.24...

Information Services at the Nuclear Safety Analysis Center.

ERIC Educational Resources Information Center

Simard, Ronald

This paper describes the operations of the Nuclear Safety Analysis Center. Established soon after an accident at the Three Mile Island nuclear power plant near Harrisburg, Pennsylvania, its efforts were initially directed towards a detailed analysis of the accident. Continuing functions include: (1) the analysis of generic nuclear safety issues,…

29 CFR 1953.6 - Review and approval of plan supplements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION...) OSHA shall review a supplement to determine whether it is at least as effective as the Federal program.... If the review reveals any defect in the supplement, or if more information is needed, OSHA shall...

29 CFR 1953.6 - Review and approval of plan supplements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 1953.6 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION...) OSHA shall review a supplement to determine whether it is at least as effective as the Federal program.... If the review reveals any defect in the supplement, or if more information is needed, OSHA shall...

Efficacy and safety of Chlorella supplementation in adults with chronic hepatitis C virus infection

PubMed Central

Azocar, Jose; Diaz, Arley

2013-01-01

AIM: To evaluate the safety and efficacy of Chlorella in 18 patients chronically infected with hepatitis C virus (HCV) genotype 1. METHODS: Eighteen adults with chronic infection by HCV genotype 1 received daily oral supplementation of Chlorella for 12 wk. Changes in the RNA levels of HCV, as well as those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were evaluated following this treatment period. Paired t tests were conducted to compare the means of the different variables at the beginning and end of the study. Side effects and quality of life aspects were also compared between weeks 0 and 12 of the study period. RESULTS: A majority 84.61% of the patients had a significant decrease in their ALT levels from week 0 to week 12. Evaluation of side effects showed that Chlorella was well tolerated. Quality of life assessment showed that 76.9 of the participants reported an improvement in their energy levels and 46.1% reported an improvement in their perception of general health. Although 69.23% also showed a decrease in their AST levels, this was not statistically significant. Most patients that exhibited an improvement in their ALT and AST levels also showed a tendency toward a decreased HCV viral load. The HCV RNA levels showed a decrease in 69.23% of the patients, which along with changes in AST/ALT ratios from week 0 to week 12, these results were not statistically significant. CONCLUSION: Chlorella supplementation was well tolerated in patients with chronic HCV and associated with a significant decrease in ALT liver enzyme levels. PMID:23467073

Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

PubMed

Lyons, Vanessa E; Popejoy, Lori L

2014-02-01

The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

Overview of Energy Systems' safety analysis report programs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

A critical appraisal of probiotics (as drugs or food supplements) in gastrointestinal diseases.

PubMed

Passariello, Annalisa; Agricole, Pascal; Malfertheiner, Peter

2014-06-01

Probiotics may be registered as food supplements or drugs. This article summarizes differences in European regulations of probiotics registered as food supplements and drugs, as well as issues related to the quality of probiotic products. For registration as a drug, the European Medicines Agency demands extensive and detailed quality, efficacy and safety evidence; whereas compulsory analyses requested for food supplements consist only in a nutritional analysis. As a result, the quality of those probiotics registered as drugs, compared to food supplements, is in general controlled with higher standards. Despite these differences and whatever the status of the probiotic product, its efficacy and safety has to be documented in well conducted randomized controlled trials (RCTs). Furthermore, this paper reviews recent evidence on the use of probiotics for gastrointestinal diseases, evaluating all the existing information up to January 2014. In all eligible published studies in which use of probiotics for gastrointestinal diseases were investigated and reported, no language limitations were applied. Special focus is placed on RCTs (or their meta-analyses) showing positive results, so that the findings may be applicable to everyday clinical practice. Currently, the best documented clinical areas appear to be probiotics efficacy for the treatment of acute gastroenteritis in children and for the prevention of antibiotic-associated diarrhea both in children and in adults. In other gastrointestinal conditions, some promising observations are emerging, but no definitive conclusions can be reached at present.

Safety analysis and review system (SARS) assessment report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

Software Safety Analysis of a Flight Guidance System

NASA Technical Reports Server (NTRS)

Butler, Ricky W. (Technical Monitor); Tribble, Alan C.; Miller, Steven P.; Lempia, David L.

2004-01-01

This document summarizes the safety analysis performed on a Flight Guidance System (FGS) requirements model. In particular, the safety properties desired of the FGS model are identified and the presence of the safety properties in the model is formally verified. Chapter 1 provides an introduction to the entire project, while Chapter 2 gives a brief overview of the problem domain, the nature of accidents, model based development, and the four-variable model. Chapter 3 outlines the approach. Chapter 4 presents the results of the traditional safety analysis techniques and illustrates how the hazardous conditions associated with the system trace into specific safety properties. Chapter 5 presents the results of the formal methods analysis technique model checking that was used to verify the presence of the safety properties in the requirements model. Finally, Chapter 6 summarizes the main conclusions of the study, first and foremost that model checking is a very effective verification technique to use on discrete models with reasonable state spaces. Additional supporting details are provided in the appendices.

Supplement to the ICRPG turbulent boundary layer nozzle analysis computer program

NASA Technical Reports Server (NTRS)

Omori, S.; Gross, K. W.

1972-01-01

A supplement is presented for a turbulent boundary layer nozzle analysis computer program. It describes the program calculation sequence and presents a detailed documentation of each subroutine. Important equations are derived explicitly, and improvements to the program are discussed.

To supplement or not to supplement: a metabolic network framework for human nutritional supplements.

PubMed

Nogiec, Christopher D; Kasif, Simon

2013-01-01

Flux balance analysis and constraint based modeling have been successfully used in the past to elucidate the metabolism of single cellular organisms. However, limited work has been done with multicellular organisms and even less with humans. The focus of this paper is to present a novel use of this technique by investigating human nutrition, a challenging field of study. Specifically, we present a steady state constraint based model of skeletal muscle tissue to investigate amino acid supplementation's effect on protein synthesis. We implement several in silico supplementation strategies to study whether amino acid supplementation might be beneficial for increasing muscle contractile protein synthesis. Concurrent with published data on amino acid supplementation's effect on protein synthesis in a post resistance exercise state, our results suggest that increasing bioavailability of methionine, arginine, and the branched-chain amino acids can increase the flux of contractile protein synthesis. The study also suggests that a common commercial supplement, glutamine, is not an effective supplement in the context of increasing protein synthesis and thus, muscle mass. Similar to any study in a model organism, the computational modeling of this research has some limitations. Thus, this paper introduces the prospect of using systems biology as a framework to formally investigate how supplementation and nutrition can affect human metabolism and physiology.

Dietary Supplements: What You Need to Know

MedlinePlus

... must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness. Manufacturers are required to produce dietary supplements in ...

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.

Efficacy of probiotic supplement for gestational diabetes mellitus: a systematic review and meta-analysis.

PubMed

Pan, Jiajia; Pan, Qiangwei; Chen, Yumei; Zhang, Hongping; Zheng, Xiaodong

2017-09-19

Probiotic supplement might be beneficial for gestational diabetes mellitus. However, the results remained controversial. We conducted a systematic review and meta-analysis to explore the efficacy of probiotic supplement in gestational diabetes mellitus. PubMed, Embase, Web of science, EBSCO, and Cochrane Library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of probiotic supplement in gestational diabetes mellitus were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome were fasting serum insulin and fasting plasma glucose. Meta-analysis was performed using the fixed-effect or random-effect model. Six RCTs involving 830 patients were included in the meta-analysis. Overall, compared with control intervention in gestational diabetes mellitus, probiotic supplementation intervention was found to significantly reduce fasting serum insulin (Std. mean difference = -0.95; 95% CI = -1.73 to -0.17; p < .00001) and HOMA-IR (Std. mean difference = -1.12; 95% CI = -2.05 to -0.18; p = .02), but showed no substantial impact on fasting plasma glucose (Std. mean difference = -0.49; 95% CI = -1.05-0.08; p = .09), gestational age (Std. mean difference = 0.07; 95% CI = -0.20-0.34; p = .63), and gestational weight (Std. mean difference = -0.11; 95% CI = -0.38-0.16; p = .43). Compared with control intervention in gestational diabetes mellitus, probiotic supplementation was found to significantly reduce insulin resistance (HOMA-IR) and fasting serum insulin, but had no substantial influence on fasting plasma glucose, gestational age and gestational weight.

Athletes and Supplements: Prevalence and Perspectives.

PubMed

Garthe, Ina; Maughan, Ronald J

2018-03-01

In elite sport, where opponents are evenly matched, small factors can determine the outcome of sporting contests. Not all athletes know the value of making wise nutrition choices, but anything that might give a competitive edge, including dietary supplements, can seem attractive. Between 40% and 100% of athletes typically use supplements, depending on the type of sport, level of competition, and the definition of supplements. However, unless the athlete has a nutrient deficiency, supplementation may not improve performance and may have a detrimental effect on both performance and health. Dietary supplements are classified as a subcategory of food, so manufacturers are not required to provide evidence of product safety and efficacy, nor obtain approval from regulatory bodies before marketing supplements. This creates the potential for health risks, and serious adverse effects have been reported from the use of some dietary supplements. Athletes who compete in sports under an anti-doping code must also realize that supplement use exposes them to a risk of ingesting banned substances or precursors of prohibited substances. Government systems of regulations do not include specific laboratory testing for banned substances according to the WADA list, so a separate regulatory framework to evaluate supplements for their risk of provoking a failed doping test is needed. In the high-performance culture typical of elite sport, athletes may use supplements regardless of possible risks. A discussion around medical, physiological, cultural, and ethical questions may be warranted to ensure that the athlete has the information needed to make an informed choice.

Nuclear criticality safety bounding analysis for the in-tank-precipitation (ITP) process, impacted by fissile isotopic weight fractions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bess, C.E.

The In-Tank Precipitation process (ITP) receives High Level Waste (HLW) supernatant liquid containing radionuclides in waste processing tank 48H. Sodium tetraphenylborate, NaTPB, and monosodium titanate (MST), NaTi{sub 2}O{sub 5}H, are added for removal of radioactive Cs and Sr, respectively. In addition to removal of radio-strontium, MST will also remove plutonium and uranium. The majority of the feed solutions to ITP will come from the dissolution of supernate that had been concentrated by evaporation to a crystallized salt form, commonly referred to as saltcake. The concern for criticality safety arises from the adsorption of U and Pt onto MST. If sufficientmore » mass and optimum conditions are achieved then criticality is credible. The concentration of u and Pt from solution into the smaller volume of precipitate represents a concern for criticality. This report supplements WSRC-TR-93-171, Nuclear Criticality Safety Bounding Analysis For The In-Tank-Precipitation (ITP) Process. Criticality safety in ITP can be analyzed by two bounding conditions: (1) the minimum safe ratio of MST to fissionable material and (2) the maximum fissionable material adsorption capacity of the MST. Calculations have provided the first bounding condition and experimental analysis has established the second. This report combines these conditions with canyon facility data to evaluate the potential for criticality in the ITP process due to the adsorption of the fissionable material from solution. In addition, this report analyzes the potential impact of increased U loading onto MST. Results of this analysis demonstrate a greater safety margin for ITP operations than the previous analysis. This report further demonstrates that the potential for criticality in the ITP process due to adsorption of fissionable material by MST is not credible.« less

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

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

A review of dietary supplement-induced renal dysfunction.

PubMed

Gabardi, Steven; Munz, Kristin; Ulbricht, Catherine

2007-07-01

Complementary and alternative medicine (CAM) is a multibillion-dollar industry. Almost half of the American population uses some form of CAM, with many using them in addition to prescription medications. Most patients fail to inform their health care providers of their CAM use, and physicians rarely inquire. Annually, thousands of dietary supplement-induced adverse events are reported to Poison Control Centers nationwide. CAM manufacturers are not responsible for proving safety and efficacy, because the Food and Drug Administration does not regulate them. However, concern exists surrounding the safety of CAM. A literature search using MEDLINE and EMBASE was undertaken to explore the impact of CAM on renal function. English-language studies and case reports were selected for inclusion but were limited to those that consisted of human subjects, both adult and pediatric. This review provides details on dietary supplements that have been associated with renal dysfunction and focuses on 17 dietary supplements that have been associated with direct renal injury, CAM-induced immune-mediated nephrotoxicity, nephrolithiasis, rhabdomyolysis with acute renal injury, and hepatorenal syndrome. It is concluded that it is imperative that use of dietary supplements be monitored closely in all patients. Health care practitioners must take an active role in identifying patients who are using CAM and provide appropriate patient education.

Motorcoach and school bus fire safety analysis.

DOT National Transportation Integrated Search

2016-11-01

This report documents a motorcoach and school bus fire safety analysis performed by the John A. Volpe National Transportation Systems Center (Volpe) for the Federal Motor Carrier Safety Administration. This report aims to: 1) identify the causes, fre...

Vitamin D supplementation during pregnancy: Updated meta-analysis on maternal outcomes.

PubMed

Palacios, Cristina; De-Regil, Luz Maria; Lombardo, Lia K; Peña-Rosas, Juan Pablo

2016-11-01

Vitamin D deficiency is highly prevalent during pregnancy. It has been suggested that vitamin D supplementation during pregnancy may reduce the risk of adverse gestational outcomes. To update a previous meta-analysis on the effects of oral vitamin D supplementation (alone or in combination with other vitamins and minerals) during pregnancy on maternal 25(OH)D levels and risk of developing pre-eclampsia, gestational diabetes, preterm birth, impaired glucose tolerance, caesarean section, gestational hypertension and other adverse conditions. We searched for randomized and quasi-randomized trials through the Cochrane Pregnancy and Childbirth Group's Trials Register, the International Clinical Trials Registry Platform, the Networked Digital Library of Theses and Dissertations, and direct communications with relevant organizations. Assessments of inclusion criteria, extraction of data from included studies, and risk of bias' assessments of the included studies were done independently by two review authors. We included 15 trials, excluded 27 trials and 23 trials are still ongoing/unpublished. Data from seven trials with 868 women suggest that pregnant women supplemented with vitamin D had significantly higher 25(OH)D levels compared to controls (mean difference: 54.7nmol/L; 95% CI 36.6, 72.9). Two trials found a lower risk of preeclampsia (8.9% versus 15.5%; average risk ratio 0.52; 95% CI 0.25, 1.05) and two other trials found no difference in the risk of gestational diabetes with vitamin D supplementation. Also, three trials found that supplementation with vitamin D plus calcium reduced the risk of pre-eclampsia (5% versus 9%; average risk ratio 0.51; 95% CI 0.32, 0.80). Supplementing pregnant women with vitamin D led to significantly higher levels of 25(OH)D at term compared to placebo/control but results were inconsistent. Vitamin D supplementation, with or without calcium, may be related to lower risk of preeclampsia but more studies are needed to confirm this

10 CFR 72.248 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

Comprehensive Safety Analysis 2010 Safety Measurement System (SMS) Methodology, Version 2.1 Revised December 2010

DOT National Transportation Integrated Search

2010-12-01

This report documents the Safety Measurement System (SMS) methodology developed to support the Comprehensive Safety Analysis 2010 (CSA 2010) Initiative for the Federal Motor Carrier Safety Administration (FMCSA). The SMS is one of the major tools for...

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

Defining attributes of patient safety through a concept analysis.

PubMed

Kim, Linda; Lyder, Courtney H; McNeese-Smith, Donna; Leach, Linda Searle; Needleman, Jack

2015-11-01

The aim of this study was to report an analysis of the concept of patient safety. Despite recent increase in the number of work being done to clarify the concept and standardize measurement of patient safety, there are still huge variations in how the term is conceptualized and how to measure patient safety data across various healthcare settings and in research. Concept analysis. A literature search was conducted through PubMed and Cumulative Index to Nursing and Allied Health Literature, Plus using the terms 'patient safety' in the title and 'concept analysis,' 'attributes' or 'definition' in the title and or abstract. All English language literature published between 2002-2014 were considered for the review. Walker and Avant's method guided this analysis. The defining attributes of patient safety include prevention of medical errors and avoidable adverse events, protection of patients from harm or injury and collaborative efforts by individual healthcare providers and a strong, well-integrated healthcare system. The application of Collaborative Alliance of Nursing Outcomes indicators as empirical referents would facilitate the measurement of patient safety. With the knowledge gained from this analysis, nurses may improve patient surveillance efforts that identify potential hazards before they become adverse events and have a stronger voice in health policy decision-making that influence implementation efforts aimed at promoting patient safety, worldwide. Further studies are needed on development of a conceptual model and framework that can aid with collection and measurement of standardized patient safety data. © 2015 John Wiley & Sons Ltd.

The safety assessment of Pythium irregulare as a producer of biomass and eicosapentaenoic acid for use in dietary supplements and food ingredients.

PubMed

Wu, Lei; Roe, Charles L; Wen, Zhiyou

2013-09-01

Polyunsaturated fatty acids, docosahexaenoic acid (DHA, 22:6, n-3), eicosapentaenoic acid (EPA, 20:5, n-3), and arachidonic acid (ARA, 20:4 n-6), have multiple beneficial effects on human health and can be used as an important ingredient in dietary supplements, food, feed and pharmaceuticals. A variety of microorganisms has been used for commercial production of these fatty acids. The microorganisms in the Pythium family, particularly Pythium irregulare, are potential EPA producers. The aim of this work is to provide a safety assessment of P. irregulare so that the EPA derived from this species can be potentially used in various commercial applications. The genus Pythium has been widely recognized as a plant pathogen by infecting roots and colonizing the vascular tissues of various plants such as soybeans, corn and various vegetables. However, the majority of the Pythium species (including P. irregulare) have not been reported to infect mammals including humans. The only species among the Pythium family that infects mammals is P. insidiosum. There also have been no reports showing P. irregulare to contain mycotoxins or cause potentially allergenic responses in humans. Based on the safety assessment, we conclude that P. irregulare can be considered a safe source of biomass and EPA-containing oil for use as ingredients in dietary supplements, food, feed and pharmaceuticals.

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.

Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

PubMed

Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

2018-02-01

Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

Integrated Safety Analysis Tiers

NASA Technical Reports Server (NTRS)

Shackelford, Carla; McNairy, Lisa; Wetherholt, Jon

2009-01-01

Commercial partnerships and organizational constraints, combined with complex systems, may lead to division of hazard analysis across organizations. This division could cause important hazards to be overlooked, causes to be missed, controls for a hazard to be incomplete, or verifications to be inefficient. Each organization s team must understand at least one level beyond the interface sufficiently enough to comprehend integrated hazards. This paper will discuss various ways to properly divide analysis among organizations. The Ares I launch vehicle integrated safety analyses effort will be utilized to illustrate an approach that addresses the key issues and concerns arising from multiple analysis responsibilities.

Preliminary Results Obtained in Integrated Safety Analysis of NASA Aviation Safety Program Technologies

NASA Technical Reports Server (NTRS)

Reveley, Mary S.

2003-01-01

The goal of the NASA Aviation Safety Program (AvSP) is to develop and demonstrate technologies that contribute to a reduction in the aviation fatal accident rate by a factor of 5 by the year 2007 and by a factor of 10 by the year 2022. Integrated safety analysis of day-to-day operations and risks within those operations will provide an understanding of the Aviation Safety Program portfolio. Safety benefits analyses are currently being conducted. Preliminary results for the Synthetic Vision Systems (SVS) and Weather Accident Prevention (WxAP) projects of the AvSP have been completed by the Logistics Management Institute under a contract with the NASA Glenn Research Center. These analyses include both a reliability analysis and a computer simulation model. The integrated safety analysis method comprises two principal components: a reliability model and a simulation model. In the reliability model, the results indicate how different technologies and systems will perform in normal, degraded, and failed modes of operation. In the simulation, an operational scenario is modeled. The primary purpose of the SVS project is to improve safety by providing visual-flightlike situation awareness during instrument conditions. The current analyses are an estimate of the benefits of SVS in avoiding controlled flight into terrain. The scenario modeled has an aircraft flying directly toward a terrain feature. When the flight crew determines that the aircraft is headed toward an obstruction, the aircraft executes a level turn at speed. The simulation is ended when the aircraft completes the turn.

Effects of Taurine Supplementation on Growth in Low Birth Weight Infants: A Systematic Review and Meta-Analysis.

PubMed

Cao, Shun-Li; Jiang, Hong; Niu, Shi-Ping; Wang, Xiao-Hu; Du, Shan

2018-01-25

To summarize the available randomized controlled trials (RCTs) to evaluate the effect of taurine supplementation on growth in low birth weight infants (LBW). PubMed, EmBase, and Cochrane Library electronic databases were searched for published articles through March 2017. Analysis was done to examine the effect of taurine supplementation on growth, and sensitivity analysis was performed by removing each individual study from meta-analysis. Results of 9 trials totaling 216 LBW infants in the present meta-analysis were collected and analyzed. The conclusion of included studies demonstrated that taurine supplementation significantly reduced length gain (WMD:-0.18; P < 0.001), plasma glycine (WMD:-106.71; P = 0.033), alanine (WMD:-229.30; P = 0.002), leucine (WMD:-64.76; P < 0.001), tyrosine (WMD:-118.11; P < 0.001), histidine (WMD:-52.16; P < 0.001), proline (WMD: -84.29; P = 0.033), and asparagine-glutamine (WMD:-356.30; P < 0.001). However, taurine supplementation was associated with higher levels of acidic sterols (WMD:0.61; P = 0.024), total fatty acids (WMD:7.94; P = 0.050), total saturated fatty acids (WMD:9.70; P < 0.001), and unsaturated fatty acids (WMD:6.63; P < 0.001). Finally, taurine supplementation had little or no significant effect on weight gain, head circumference gain, plasma taurine, threonine, serine, citrulline, valine, methionine, isoleucine, phenylalanine, ornithine, lysine, arginine, glutamate, hydroxyproline, aspartate, dietary cholesterol, endogenous neutral sterols, cholesterol synthesis, and medium-chain triglycerides. The findings suggest that although there are several significant differences in plasma indeces, no significant effect on growth in LBW infants was observed with taurine supplementation.

Safety, Efficacy, and Legal Issues Related to Dietary Supplements

ERIC Educational Resources Information Center

Powers, Michael

2004-01-01

This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

CloudSat Safety Operations at Vandenberg AFB

NASA Technical Reports Server (NTRS)

Greenberg, Steve

2006-01-01

CloudSat safety operations at Vendenberg AFB is given. The topics include: 1) CloudSat Project Overview; 2) Vandenberg Ground Operations; 3) Delta II Launch Vehicle; 4) The A-Train; 5) System Safety Management; 6) CALIPSO Hazards Assessment; 7) CALIPSO Supplemental Safeguards; 8) Joint System Safety Operations; 9) Extended Stand-down; 10) Launch Delay Safety Concerns; and 11) Lessons Learned.

Safety issues with herbal products.

PubMed

Marrone, C M

1999-12-01

To review safety issues associated with the use of herbal products. Literature accessed through MEDLINE and other Internet search engines. Key search terms included herbs, dietary supplements, and safety. A misconception exists among consumers that herbal remedies are safe because they are natural. In an effort to provide healthcare practitioners with information necessary for a patient discussion, a review of safety concerns with herbal products was conducted. Several safety concerns exist with herbal products including lack of safety data, absence of quality-control requirements for potency and purity, and lenient labeling standards.

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

COLD-SAT feasibility study safety analysis

NASA Technical Reports Server (NTRS)

Mchenry, Steven T.; Yost, James M.

1991-01-01

The Cryogenic On-orbit Liquid Depot-Storage, Acquisition, and Transfer (COLD-SAT) satellite presents some unique safety issues. The feasibility study conducted at NASA-Lewis desired a systems safety program that would be involved from the initial design in order to eliminate and/or control the inherent hazards. Because of this, a hazards analysis method was needed that: (1) identified issues that needed to be addressed for a feasibility assessment; and (2) identified all potential hazards that would need to be controlled and/or eliminated during the detailed design phases. The developed analysis method is presented as well as the results generated for the COLD-SAT system.

Effect of Whey Supplementation on Circulating C-Reactive Protein: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Zhou, Ling-Mei; Xu, Jia-Ying; Rao, Chun-Ping; Han, Shufen; Wan, Zhongxiao; Qin, Li-Qiang

2015-01-01

Whey supplementation is beneficial for human health, possibly by reducing the circulating C-reactive protein (CRP) level, a sensitive marker of inflammation. Thus, a meta-analysis of randomized controlled trials was conducted to evaluate their relationship. A systematic literature search was conducted in July, 2014, to identify eligible studies. Either a fixed-effects model or a random-effects model was used to calculate pooled effects. The meta-analysis results of nine trials showed a slight, but no significant, reduction of 0.42 mg/L (95% CI −0.96, 0.13) in CRP level with the supplementation of whey protein and its derivates. Relatively high heterogeneity across studies was observed. Subgroup analyses showed that whey significantly lowered CRP by 0.72 mg/L (95% CI −0.97, −0.47) among trials with a daily whey dose ≥20 g/day and by 0.67 mg/L (95% CI −1.21, −0.14) among trials with baseline CRP ≥3 mg/L. Meta-regression analysis revealed that the baseline CRP level was a potential effect modifier of whey supplementation in reducing CRP. In conclusion, our meta-analysis did not find sufficient evidence that whey and its derivates elicited a beneficial effect in reducing circulating CRP. However, they may significantly reduce CRP among participants with highly supplemental doses or increased baseline CRP levels. PMID:25671415

An Illustrated Guide to Electrical Safety. Revised

ERIC Educational Resources Information Center

Occupational Safety and Health Administration, Washington, DC.

This guide was developed to serve as a supplement to the Occupational Safety and Health Administration's (OSHA) Electrical Safety Standards, 29 CFR 1910, Subpart S, Electrical. It is designed for use by a variety of people (layman, worker, employer, compliance safety and health officer, union official, educator, and others) in training, education,…

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

Calcium supplementation and cardiovascular risk: A rising concern.

PubMed

Tankeu, Aurel T; Ndip Agbor, Valirie; Noubiap, Jean Jacques

2017-06-01

Over the past decade, the number of individuals taking calcium supplementation worldwide has been on the rise, especially with the emergence of new pharmaceutical companies specialized in the marketing of dietary supplements; with calcium supplementation being their main business axis. This is mostly because of the established role of calcium in the prevention and treatment of osteoporosis and, to a lesser extent, its role in the prevention of fractures. Recently, a rising body of evidence on the adverse effect of calcium supplementation on nonskeletal, especially cardiovascular, health has been a cause for concern. In fact, a significant number of studies have reported an association between calcium supplementation and adverse cardiovascular events, even though high dietary calcium intake was shown to have a protective effect. The mechanism by which calcium supplementation could cause a cardiovascular event was still unclear until a recent study published in the Journal of the American Heart Association. Combining this recent finding with available data associating calcium supplementation with cardiovascular mortality and all-cause mortality, we call on the need for an evidence-based approach to calcium supplementation, while stressing on the safety of dietary calcium intake over the former on cardiovascular health. ©2017 Wiley Periodicals, Inc.

Improving safety on rural local and tribal roads site safety analysis - user guide #1.

DOT National Transportation Integrated Search

2014-08-01

This User Guide presents an example of how rural local and Tribal practitioners can study conditions at a preselected site. It demonstrates the step-by-step safety analysis process presented in Improving Safety on Rural Local and Tribal Roads Saf...

Fiber and prebiotic supplementation in enteral nutrition: A systematic review and meta-analysis

PubMed Central

Kamarul Zaman, Mazuin; Chin, Kin-Fah; Rai, Vineya; Majid, Hazreen Abdul

2015-01-01

AIM: To investigate fiber and prebiotic supplementation of enteral nutrition (EN) for diarrhea, fecal microbiota and short-chain fatty acids (SCFAs). METHODS: MEDLINE, EMBASE, Cochrane Library, CINAHL, Academic Search Premier, and Web of Science databases were searched for human experimental and observational cohort studies conducted between January 1990 and June 2014. The keywords used for the literature search were fiber, prebiotics and enteral nutrition. English language studies with adult patient populations on exclusive EN were selected. Abstracts and/or full texts of selected studies were reviewed and agreed upon by two independent researchers for inclusion in the meta-analysis. Tools used for the quality assessment were Jadad Scale and the Scottish Intercollegiate Guidelines Network Critical Appraisal of the Medical Literature. RESULTS: A total of 456 possible articles were retrieved, and 430 were excluded due to lack of appropriate data. Of the 26 remaining studies, only eight investigated the effects of prebiotics. Results of the meta-analysis indicated that overall, fiber reduces diarrhea in patients receiving EN (OR = 0.47; 95%CI: 0.29-0.77; P = 0.02). Subgroup analysis revealed a positive effect of fiber supplementation in EN towards diarrhea in stable patients (OR = 0.31; 95%CI: 0.19-0.51; P < 0.01), but not in critically ill patients (OR = 0.89; 95%CI: 0.41-1.92; P = 0.77). Prebiotic supplementation in EN does not improve the incidence of diarrhea despite its manipulative effect on bifidobacteria concentrations and SCFA in healthy humans. In addition, the effect of fiber and/or prebiotic supplementation towards fecal microbiota and SCFA remain disputable. CONCLUSION: Fiber helps minimize diarrhea in patients receiving EN, particularly in non-critically ill patients. However, the effect of prebiotics in moderating diarrhea is inconclusive. PMID:25954112

The effect of vitamin D supplementation on knee osteoarthritis: A meta-analysis of randomized controlled trials.

PubMed

Gao, Xu-Ren; Chen, Ye-Shuai; Deng, Wei

2017-10-01

We conducted a meta-analysis of RCTs to evaluate the effects of vitamin D supplementation in the prevention of symptom and structural progression of knee OA. PubMed, Embase, and Web of Science databases were searched to identify relevant studies. Outcomes included Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, function, stiffness, tibial cartilage volume, and serum vitamin D3 levels, and adverse events. Results were expressed as weight mean difference (WMD) with 95% confidence interval (CI), and risk ratio (RR) with 95%CI. Four RCTs involving 1136 patients were included in this study. Pooled estimates suggested that vitamin D supplementation was associated with a significant reduction in WOMAC pain, and WOMAC function, but not in WOMAC stiffness. Vitamin D supplementation increased the serum vitamin D3 level, but had no effect on tibial cartilage volume. Subgroup analysis showed that, a daily supplement of more than 2000 IU vitamin D significantly decreased the WOMAC pain and WOMAC function. There was no significant difference in incidence of adverse events between the vitamin D and placebo groups. Vitamin D supplementation was effective in improving the WOMAC pain and function in patients with knee OA. However, it had no beneficial effect on the prevention of tibial cartilage loss. Therefore, there is currently a lack of evidence to support the use of vitamin D supplementation in preventing the progression of knee OA. Copyright © 2017. Published by Elsevier Ltd.

Meta-analysis and meta-regression of omega-3 polyunsaturated fatty acid supplementation for major depressive disorder.

PubMed

Mocking, R J T; Harmsen, I; Assies, J; Koeter, M W J; Ruhé, H G; Schene, A H

2016-03-15

Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been proposed as (adjuvant) treatment for major depressive disorder (MDD). In the present meta-analysis, we pooled randomized placebo-controlled trials assessing the effects of omega-3 PUFA supplementation on depressive symptoms in MDD. Moreover, we performed meta-regression to test whether supplementation effects depended on eicosapentaenoic acid (EPA) or docosahexaenoic acid dose, their ratio, study duration, participants' age, percentage antidepressant users, baseline MDD symptom severity, publication year and study quality. To limit heterogeneity, we only included studies in adult patients with MDD assessed using standardized clinical interviews, and excluded studies that specifically studied perinatal/perimenopausal or comorbid MDD. Our PubMED/EMBASE search resulted in 1955 articles, from which we included 13 studies providing 1233 participants. After taking potential publication bias into account, meta-analysis showed an overall beneficial effect of omega-3 PUFAs on depressive symptoms in MDD (standardized mean difference=0.398 (0.114-0.682), P=0.006, random-effects model). As an explanation for significant heterogeneity (I(2)=73.36, P<0.001), meta-regression showed that higher EPA dose (β=0.00037 (0.00009-0.00065), P=0.009), higher percentage antidepressant users (β=0.0058 (0.00017-0.01144), P=0.044) and earlier publication year (β=-0.0735 (-0.143 to 0.004), P=0.04) were significantly associated with better outcome for PUFA supplementation. Additional sensitivity analyses were performed. In conclusion, present meta-analysis suggested a beneficial overall effect of omega-3 PUFA supplementation in MDD patients, especially for higher doses of EPA and in participants taking antidepressants. Future precision medicine trials should establish whether possible interactions between EPA and antidepressants could provide targets to improve antidepressant response and its prediction. Furthermore, potential

Safety and business benefit analysis of NASA's aviation safety program

DOT National Transportation Integrated Search

2004-09-20

NASA Aviation Safety Program elements encompass a wide range of products that require both public and private investment. Therefore, two methods of analysis, one relating to the public and the other to the private industry, must be combined to unders...

Supplement Analysis for Yakima/Klickitat Fisheries Project, (DOE/EIS-0169-SA-05)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Patricia R.

2002-09-20

Yakima/Klickitat Fisheries Project – Under the Monitoring and Evaluation Program (M&E), the domestication selection research task would be modified to include a hatchery control line, maintained entirely by spawning hatchery-origin fish. The Bonneville Power Administration is funding ongoing studies, research, and artificial production of several salmonid species in the Yakima and Klickitat river basins. BPA analyzed environmental impacts of research and supplementation projects in the Yakima basin in an Environmental Impact Statement (EIS) completed in 1996 (USDOE/BPA 1996), and in the following Supplement Analyses: DOE/EIS-0169-SA-01, completed in May 1999; DOE/EIS-0169-SA-02, completed in August 1999; DOE/EIS-0169-SA-03, completed in 2000; DOE/EIS-0169-SA-04, completedmore » in November 2000. The purpose of this Supplement Analysis is to determine if a Supplemental EIS is needed to analyze the changes proposed in the Monitoring and Evaluation program (#199506325) of the Yakima Klickitat Fisheries Project (YKFP) as reviewed in the FY 2001 Project Proposals for the Columbia River Gorge and Inter-Mountain Provinces, ISRP 2000-9 (December 1, 2000). Modifications to the M&E program are in support of the experimental acclimation, rearing and incubating activities for spring chinook.« less

[Hypervitaminosis D due to a dietary supplement].

PubMed

Zigenhorn, Maaike; Westerman, Elsbeth M; Rietveld, Arie P

2016-01-01

In the Netherlands, over-the-counter dietary supplements are controlled by the NVWA (Netherlands Food and Consumer Product Safety Authority). Nevertheless, health problems may ensue from the use of these freely available supplements. We describe the case of a 39-year-old woman with a four-week history of headaches, nausea, reduced appetite and weight loss. Laboratory results showed severe hypercalcemia and impaired kidney function. An isolated increased vitamin D level was shown to be the cause. Although initial drug-taking history was negative, it appeared our patient had consumed a concentrated vitamin D supplement, supplied by a naturopath. The vitamin D concentration of the contents of this specific flacon proved to be 78 times higher than stated on the label. Consumers must be aware of the potential health risks posed by over-the-counter dietary supplements. We appeal to GPs, medical specialists and pharmacists to report these kinds of intoxications, allowing relevant authorities to subject the associated companies to adequate control measures.

Term Coverage of Dietary Supplements Ingredients in Product Labels.

PubMed

Wang, Yefeng; Adam, Terrence J; Zhang, Rui

2016-01-01

As the clinical application and consumption of dietary supplements has grown, their side effects and possible interactions with prescribed medications has become a serious issue. Information extraction of dietary supplement related information is a critical need to support dietary supplement research. However, there currently is not an existing terminology for dietary supplements, placing a barrier for informatics research in this field. The terms related to dietary supplement ingredients should be collected and normalized before a terminology can be established to facilitate convenient search on safety information and control possible adverse effects of dietary supplements. In this study, the Dietary Supplement Label Database (DSLD) was chosen as the data source from which the ingredient information was extracted and normalized. The distribution based on the product type and the ingredient type of the dietary supplements were analyzed. The ingredient terms were then mapped to the existing terminologies, including UMLS, RxNorm and NDF-RT by using MetaMap and RxMix. The large gap between existing terminologies and ingredients were found: only 14.67%, 19.65%, and 12.88% of ingredient terms were covered by UMLS, RxNorm and NDF-RT, respectively.

Arsenic speciation and fucoxanthin analysis from seaweed dietary supplements using LC-MS

USDA-ARS?s Scientific Manuscript database

Inorganic species are considered more toxic to humans than organic arsenic and total arsenic. Analysis of total arsenic in metallic form, organic and inorganic arsenic species from seaweeds and dietary supplements using LC-ICP-MS was developed. Solvent extraction with sonication and microwave extr...

NASA Safety Manual. Volume 3: System Safety

NASA Technical Reports Server (NTRS)

1970-01-01

This Volume 3 of the NASA Safety Manual sets forth the basic elements and techniques for managing a system safety program and the technical methods recommended for use in developing a risk evaluation program that is oriented to the identification of hazards in aerospace hardware systems and the development of residual risk management information for the program manager that is based on the hazards identified. The methods and techniques described in this volume are in consonance with the requirements set forth in NHB 1700.1 (VI), Chapter 3. This volume and future volumes of the NASA Safety Manual shall not be rewritten, reprinted, or reproduced in any manner. Installation implementing procedures, if necessary, shall be inserted as page supplements in accordance with the provisions of Appendix A. No portion of this volume or future volumes of the NASA Safety Manual shall be invoked in contracts.

Recent Progresses in Nanobiosensing for Food Safety Analysis

PubMed Central

Yang, Tao; Huang, Huifen; Zhu, Fang; Lin, Qinlu; Zhang, Lin; Liu, Junwen

2016-01-01

With increasing adulteration, food safety analysis has become an important research field. Nanomaterials-based biosensing holds great potential in designing highly sensitive and selective detection strategies necessary for food safety analysis. This review summarizes various function types of nanomaterials, the methods of functionalization of nanomaterials, and recent (2014–present) progress in the design and development of nanobiosensing for the detection of food contaminants including pathogens, toxins, pesticides, antibiotics, metal contaminants, and other analytes, which are sub-classified according to various recognition methods of each analyte. The existing shortcomings and future perspectives of the rapidly growing field of nanobiosensing addressing food safety issues are also discussed briefly. PMID:27447636

Recent Progresses in Nanobiosensing for Food Safety Analysis.

PubMed

Yang, Tao; Huang, Huifen; Zhu, Fang; Lin, Qinlu; Zhang, Lin; Liu, Junwen

2016-07-19

With increasing adulteration, food safety analysis has become an important research field. Nanomaterials-based biosensing holds great potential in designing highly sensitive and selective detection strategies necessary for food safety analysis. This review summarizes various function types of nanomaterials, the methods of functionalization of nanomaterials, and recent (2014-present) progress in the design and development of nanobiosensing for the detection of food contaminants including pathogens, toxins, pesticides, antibiotics, metal contaminants, and other analytes, which are sub-classified according to various recognition methods of each analyte. The existing shortcomings and future perspectives of the rapidly growing field of nanobiosensing addressing food safety issues are also discussed briefly.

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

Mine safety assessment is a precondition for ensuring orderly and safety in production. The main purpose of this study was to prevent mine accidents more effectively by proposing a composite risk analysis model. First, the weights of the assessment indicators were determined by the revised integrated weight method, in which the objective weights were determined by a variation coefficient method and the subjective weights determined by the Delphi method. A new formula was then adopted to calculate the integrated weights based on the subjective and objective weights. Second, after the assessment indicator weights were determined, gray relational analysis was used to evaluate the safety of mine enterprises. Mine enterprise safety was ranked according to the gray relational degree, and weak links of mine safety practices identified based on gray relational analysis. Third, to validate the revised integrated weight method adopted in the process of gray relational analysis, the fuzzy evaluation method was used to the safety assessment of mine enterprises. Fourth, for first time, bow tie model was adopted to identify the causes and consequences of weak links and allow corresponding safety measures to be taken to guarantee the mine’s safe production. A case study of mine safety assessment was presented to demonstrate the effectiveness and rationality of the proposed composite risk analysis model, which can be applied to other related industries for safety evaluation. PMID:29561875

A Rapid Analytical Method for Determination of Aflatoxins in Plant-Derived Dietary Supplement and Cosmetic Oils

PubMed Central

Mahoney, Noreen; Molyneux, Russell J.

2010-01-01

Consumption of edible oils derived from conventional crop plants is increasing because they are generally regarded as more healthy alternatives to animal based fats and oils. More recently there has been increased interest in the use of alternative specialty plant-derived oils, including those from tree nuts (almonds, pistachios and walnuts) and botanicals (borage, evening primrose and perilla) both for direct human consumption (e.g. as salad dressings) but also for preparation of cosmetics, soaps, and fragrance oils. This has raised the issue as to whether or not exposure to aflatoxins can result from such oils. Although most crops are subject to analysis and control, it has generally been assumed that plant oils do not retain aflatoxins due to their high polarity and lipophobicity of these compounds. There is virtually no scientific evidence to support this supposition and available information is conflicting. To improve the safety and consistency of botanicals and dietary supplements, research is needed to establish whether or not oils used directly, or in the formulation of products, contain aflatoxins. A validated analytical method for the analysis of aflatoxins in plant-derived oils is essential, in order to establish the safety of dietary supplements for consumption or cosmetic use that contain such oils. The aim of this research was therefore to develop an HPLC method applicable to a wide variety of oils from different plant sources spiked with aflatoxins, thereby providing a basis for a comprehensive project to establish an intra- and inter-laboratory validated analytical method for analysis of aflatoxins in dietary supplements and cosmetics formulated with plant oils. PMID:20235534

Safety analysis in test facility design

NASA Astrophysics Data System (ADS)

Valk, A.; Jonker, R. J.

1990-09-01

The application of safety analysis techniques as developed in, for example nuclear and petrochemical industry, can be very beneficial in coping with the increasing complexity of modern test facility installations and their operations. To illustrate the various techniques available and their phasing in a project, an overview of the most commonly used techniques is presented. Two case studies are described: the hazard and operability study techniques and safety zoning in relation to the possible presence of asphyxiating atmospheres.

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

Efficacy of vitamin and antioxidant supplements in prevention of cardiovascular disease: systematic review and meta-analysis of randomised controlled trials

PubMed Central

Ju, Woong; Oh, Seung-Won; Park, Sang Min; Koo, Bon-Kwon; Park, Byung-Joo

2013-01-01

Objective To assess the efficacy of vitamin and antioxidant supplements in the prevention of cardiovascular diseases. Design Meta-analysis of randomised controlled trials. Data sources and study selection PubMed, EMBASE, the Cochrane Library, Scopus, CINAHL, and ClinicalTrials.gov searched in June and November 2012. Two authors independently reviewed and selected eligible randomised controlled trials, based on predetermined selection criteria. Results Out of 2240 articles retrieved from databases and relevant bibliographies, 50 randomised controlled trials with 294 478 participants (156 663 in intervention groups and 137 815 in control groups) were included in the final analyses. In a fixed effect meta-analysis of the 50 trials, supplementation with vitamins and antioxidants was not associated with reductions in the risk of major cardiovascular events (relative risk 1.00, 95% confidence interval 0.98 to 1.02; I2=42%). Overall, there was no beneficial effect of these supplements in the subgroup meta-analyses by type of prevention, type of vitamins and antioxidants, type of cardiovascular outcomes, study design, methodological quality, duration of treatment, funding source, provider of supplements, type of control, number of participants in each trial, and supplements given singly or in combination with other supplements. Among the subgroup meta-analyses by type of cardiovascular outcomes, vitamin and antioxidant supplementation was associated with a marginally increased risk of angina pectoris, while low dose vitamin B6 supplementation was associated with a slightly decreased risk of major cardiovascular events. Those beneficial or harmful effects disappeared in subgroup meta-analysis of high quality randomised controlled trials within each category. Also, even though supplementation with vitamin B6 was associated with a decreased risk of cardiovascular death in high quality trials, and vitamin E supplementation with a decreased risk of myocardial infarction

Quality control of plant food supplements.

PubMed

Sanzini, Elisabetta; Badea, Mihaela; Santos, Ariana Dos; Restani, Patrizia; Sievers, Hartwig

2011-12-01

It is essential to guarantee the safety of unprocessed plants and food supplements if consumers' health is to be protected. Although botanicals and their preparations are regulated at EU level, at least in part, there is still considerable discretion at national level, and Member States may choose to classify a product either as a food supplement or as a drug. Accurate data concerning the finished products and the plant used as the starting point are of major importance if risks and safety are to be properly assessed, but in addition standardized criteria for herbal preparation must be laid down and respected by researchers and manufacturers. Physiologically active as well as potentially toxic constituents need to be identified, and suitable analytical methods for their measurement specified, particularly in view of the increasing incidence of economically motivated adulteration of herbal raw materials and extracts. It remains the duty of food operators to keep up with the scientific literature and to provide sufficient information to enable the adaptation of specifications, sampling schemes and analytical methods to a fast-changing environment.

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.

Posttest analysis of the FFTF inherent safety tests

DOE Office of Scientific and Technical Information (OSTI.GOV)

Padilla, A. Jr.; Claybrook, S.W.

Inherent safety tests were performed during 1986 in the 400-MW (thermal) Fast Flux Test Facility (FFTF) reactor to demonstrate the effectiveness of an inherent shutdown device called the gas expansion module (GEM). The GEM device provided a strong negative reactivity feedback during loss-of-flow conditions by increasing the neutron leakage as a result of an expanding gas bubble. The best-estimate pretest calculations for these tests were performed using the IANUS plant analysis code (Westinghouse Electric Corporation proprietary code) and the MELT/SIEX3 core analysis code. These two codes were also used to perform the required operational safety analyses for the FFTF reactormore » and plant. Although it was intended to also use the SASSYS systems (core and plant) analysis code, the calibration of the SASSYS code for FFTF core and plant analysis was not completed in time to perform pretest analyses. The purpose of this paper is to present the results of the posttest analysis of the 1986 FFTF inherent safety tests using the SASSYS code.« less

Relationships between psychological safety climate facets and safety behavior in the rail industry: a dominance analysis.

PubMed

Morrow, Stephanie L; McGonagle, Alyssa K; Dove-Steinkamp, Megan L; Walker, Curtis T; Marmet, Matthew; Barnes-Farrell, Janet L

2010-09-01

The goals of this study were twofold: (1) to confirm a relationship between employee perceptions of psychological safety climate and safety behavior for a sample of workers in the rail industry and (2) to explore the relative strengths of relationships between specific facets of safety climate and safety behavior. Non-management rail maintenance workers employed by a large North American railroad completed a survey (n=421) regarding workplace safety perceptions and behaviors. Three facets of safety climate (management safety, coworker safety, and work-safety tension) were assessed as relating to individual workers' reported safety behavior. All three facets were significantly associated with safety behavior. Dominance analysis was used to assess the relative importance of each facet as related to the outcome, and work-safety tension evidenced the strongest relationship with safety behavior. Published by Elsevier Ltd.

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.

Roadway safety analysis methodology for Utah : final report.

DOT National Transportation Integrated Search

2016-12-01

This research focuses on the creation of a three-part Roadway Safety Analysis methodology that applies and automates the cumulative work of recently-completed roadway safety research. The first part is to prepare the roadway and crash data for analys...

Calcium plus vitamin D supplementation and risk of fractures: an updated meta analysis from the National Osteoporosis Foundation

USDA-ARS?s Scientific Manuscript database

Introduction: Calcium plus vitamin D supplementation has been widely recommended to prevent osteoporosis and subsequent fractures; however, considerable controversy exists regarding the association of such supplementation and fracture risk. The aim was to conduct a meta-analysis of randomized contr...

The role of professional communities in governing patient safety.

PubMed

Turner, Simon; Ramsay, Angus; Fulop, Naomi

2013-01-01

Using the example of medication safety, this paper aims to explore the impact of three managerial interventions (adverse incident reporting, ward-level support by pharmacists, and a medication safety subcommittee) on different professional communities situated in the English National Health Service (NHS). Semi-structured interviews were conducted with clinical and managerial staff from two English NHS acute trusts, supplemented with meeting observations and documentary analysis. Attitudes toward managerial intervention differ by professional community (between doctors, nurses and pharmacists) according to their existing norms of safety and perceptions of formal governance processes. The heterogeneity of social norms across different professional communities and medical specialties has implications for the design of organisational learning mechanisms in the field of patient safety. The paper shows that theorisation of professional "resistance" to managerialism privileges the study of doctors' reactions to management with the consequent neglect of the perceptions of other professional communities.

Glutamine Supplementation in Sick Children: Is It Beneficial?

PubMed Central

Mok, Elise; Hankard, Régis

2011-01-01

The purpose of this review is to provide a critical appraisal of the literature on Glutamine (Gln) supplementation in various conditions or illnesses that affect children, from neonates to adolescents. First, a general overview of the proposed mechanisms for the beneficial effects of Gln is provided, and subsequently clinical studies are discussed. Despite safety, studies are conflicting, partly due to different effects of enteral and parenteral Gln supplementation. Further insufficient evidence is available on the benefits of Gln supplementation in pediatric patients. This includes premature infants, infants with gastrointestinal disease, children with Crohn's disease, short bowel syndrome, malnutrition/diarrhea, cancer, severe burns/trauma, Duchenne muscular dystrophy, sickle cell anemia, cystic fibrosis, and type 1 diabetes. Moreover, methodological issues have been noted in some studies. Further mechanistic data is needed along with large randomized controlled trials in select populations of sick children, who may eventually benefit from supplemental Gln. PMID:22175008

Calcium Supplements and Cardiovascular Disease: A Review.

PubMed

Waldman, Talya; Sarbaziha, Raheleh; Merz, C Noel Bairey; Shufelt, Chrisandra

2015-07-01

Dietary or supplemental calcium intake has long been encouraged for optimal bone health. However, more recently, the safety of calcium supplementation has been questioned because of a possible association between supplemental calcium and cardiovascular risk. Whereas calcium may have a beneficial or neutral effect on cardiovascular risk factors such as blood pressure, cholesterol, weight, and diabetes, available evidence does not provide a definitive answer for an association with cardiovascular disease (CVD). To date, no calcium trials have studied cardiovascular disease as a primary end point, and larger trials with longer follow-up are needed. In this review, we present results from observational studies and randomized controlled trials (RCTs) that have evaluated calcium intake (dietary or supplemental) in relation to cardiovascular risk factors and cardiovascular disease as a secondary outcome. Results from RCTs are mixed regarding CVD risk in those using supplemental calcium with or without vitamin D, and more large-scale randomized trials designed specifically with CVD as the primary end point are needed. Evidence suggests that it is reasonable to encourage adequate dietary calcium intake, especially for postmenopausal women who are at greatest risk for osteoporotic fracture.

Does vitamin D supplementation alter plasma adipokines concentrations? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Dinca, Madalina; Serban, Maria-Corina; Sahebkar, Amirhossein; Mikhailidis, Dimitri P; Toth, Peter P; Martin, Seth S; Blaha, Michael J; Blüher, Matthias; Gurban, Camelia; Penson, Peter; Michos, Erin D; Hernandez, Adrian V; Jones, Steven R; Banach, Maciej

2016-05-01

We aimed to elucidate the role of vitamin D supplementation on adipokines through a systematic review and a meta-analysis of randomized placebo-controlled trials (RCTs). The search included PUBMED, Scopus, Web of Science and Google Scholar through July 1st, 2015. Finally we identified 9 RCTs and 484 participants. Meta-analysis of data from 7 studies did not find a significant change in plasma adiponectin concentrations following vitamin D supplementation (mean difference [MD]: 4.45%, 95%CI: -3.04, 11.93, p=0.244; Q=2.18, I(2)=0%). In meta-regression, changes in plasma adiponectin concentrations following vitamin D supplementation were found to be independent of treatment duration (slope: 0.25; 95%CI: -0.69, 1.19; p=0.603) and changes in serum 25-hydroxy vitamin D [25(OH)D] levels (slope: -0.02; 95%CI: -0.15, 0.12; p=0.780). Meta-analysis of data from 6 studies did not find a significant change in plasma leptin concentrations following vitamin D supplementation (MD: -4.51%, 95%CI: -25.13, 16.11, p=0.668; Q=6.41, I(2)=21.97%). Sensitivity analysis showed that this effect size is sensitive to one of the studies; removing it resulted in a significant reduction in plasma leptin levels (MD: -12.81%, 95%CI: -24.33, -1.30, p=0.029). In meta-regression, changes in plasma leptin concentrations following vitamin D supplementation were found to be independent of treatment duration (slope: -1.93; 95%CI: -4.08, 0.23; p=0.080). However, changes in serum 25(OH)D were found to be significantly associated with changes in plasma leptin levels following vitamin D supplementation (slope: 1.05; 95%CI: 0.08, 2.02; p=0.033). In conclusion, current data did not indicate a significant effect of vitamin D supplementation on adiponectin and leptin levels. Copyright © 2016 Elsevier Ltd. All rights reserved.

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 3: Nuclear Safety Analysis Document (NSAD)

NASA Technical Reports Server (NTRS)

1972-01-01

Nuclear safety analysis as applied to a space base mission is presented. The nuclear safety analysis document summarizes the mission and the credible accidents/events which may lead to nuclear hazards to the general public. The radiological effects and associated consequences of the hazards are discussed in detail. The probability of occurrence is combined with the potential number of individuals exposed to or above guideline values to provide a measure of accident and total mission risk. The overall mission risk has been determined to be low with the potential exposure to or above 25 rem limited to less than 4 individuals per every 1000 missions performed. No radiological risk to the general public occurs during the prelaunch phase at KSC. The most significant risks occur from prolonged exposure to reactor debris following land impact generally associated with the disposal phase of the mission where fission product inventories can be high.

[Effects of organic selenium supplement on glutathione peroxidase activities: a meta-analysis of randomized controlled trials].

PubMed

Jiang, Xia; Dong, Jiayi; Wang, Bo; Yin, Xuebin; Qin, Liqiang

2012-01-01

To study the effects of organic selenium supplementation on glutathione peroxidase (GPx) activities. Randomized controlled trials (RCT) published from January 1988 to December 2010 on the relationship between organic selenium supplementation and GPx activities were collected. Meta-analysis was applied to estimate the combined standardized mean difference (SMD) and 95% confidence interval (95% CI). A total of 10 RCTs were included. The number of studies observing GPx activities in plasma, erythrocyte and platelet was 8, 5 and 5, respectively. Compared with the controls, the combined SMD (95% CI) of GPx activities in plasma, erythrocyte and platelet of subjects supplemented with organic selenium was 0.46 (0.09 - 0.83), 0.36 (0.02 - 0.69) and 0.56 (-0.02 - 1.15). Supplementation with organic selenium increases GPx activities in healthy adults.

Effect of ram semen extenders and supplements on computer assisted sperm analysis parameters

USDA-ARS?s Scientific Manuscript database

A study evaluated the effects of ram semen extender and extender supplementation on computer assisted sperm analysis (CASA) parameters positively correlated with progressive motility. Semen collected from 5 rams was distributed across treatment combinations consisting of either TRIS citrate (T) or ...

A cocktail of synthetic stimulants found in a dietary supplement associated with serious adverse events.

PubMed

Venhuis, Bastiaan; Keizers, Peter; van Riel, Antoinette; de Kaste, Dries

2014-06-01

Food supplements are regularly found to contain pharmacologically active substances. Recently, the food supplement Dexaprine was removed from the Dutch market because it was associated with severe adverse events. Reports to the Dutch Poisons Information Center (DPIC) showed that ingestion of as little as half a tablet caused several cases of nausea, agitation, tachycardia, and palpitations and even one case of cardiac arrest. The remaining tablets of four patients were sent in by different healthcare professionals. Analysis by ultra-performance liquid chromatography quadrupole time of flight mass-spectrometry (UPLC-QTOF-MS) confirmed the presence of synephrine, oxilofrine, deterenol, yohimbine, caffeine, and theophylline. Two more compounds were found which were tentatively identified as β-methyl-β-phenylethylamines. This incident is only the next in a series of similar incidents involving dietary supplements with (undeclared) active substances that are either unsafe or have no known safety profile. Copyright © 2014 John Wiley & Sons, Ltd.

Meta-analysis of the influence of Saccharomyces cerevisiae supplementation on ruminal parameters and milk production of ruminants.

PubMed

Desnoyers, M; Giger-Reverdin, S; Bertin, G; Duvaux-Ponter, C; Sauvant, D

2009-04-01

The effects of yeast supplementation on intake, production, and rumen fermentation characteristics have been widely studied, but results are inconsistent between different studies. A quantitative meta-analysis was applied to 110 papers, 157 experiments, and 376 treatments dealing with yeast supplementation in ruminants. The objective was first to highlight the major quantitative effects of live yeast supplementation on intake, rumen fermentation, and milk production, and second, to identify major differences in experimental conditions between studies that can affect the response to treatment. Some of these experimental conditions are referred to as interfering factors. Yeast supplementation increased rumen pH (+0.03 on average) and rumen volatile fatty acid concentration (+2.17 mM on average), tended to decrease rumen lactic acid concentration (-0.9 mM on average), and had no influence on acetate-to-propionate ratio. Total-tract organic matter digestibility was also increased by yeast supplementation (+0.8% on average). Yeast supplementation increased dry matter intake (DMI; +0.44 g/kg of body weight; BW), milk yield (+1.2 g/kg of BW), and tended to increase milk fat content (+0.05%), but had no influence on milk protein content. Dose effects of yeast supplementation, expressed as log(10) [1+(cfu per 100 kg of BW)], globally confirmed the qualitative effects observed in the first analysis. The positive effect of yeast supplementation on rumen pH increased with the percentage of concentrate in the diet and with the DMI level. It was negatively correlated with the level of dietary neutral detergent fiber (NDF). The positive effect of yeast supplementation on rumen volatile fatty acid concentration increased with DMI and crude protein levels. The positive effect of yeast supplementation on organic matter digestibility increased with the percentage of concentrate and NDF in the diet. The negative effect of yeast supplementation on lactic acid concentration tended to

Oral Omega-3 Supplementation Lowers Intraocular Pressure in Normotensive Adults.

PubMed

Downie, Laura Elizabeth; Vingrys, Algis Jonas

2018-05-01

Elevated intraocular pressure (IOP) is the major modifiable risk factor for the sight-threatening eye disease, glaucoma. We investigated whether oral omega-3 supplements affect IOP in normotensive adults. We undertook a pooled analysis of data from two double-masked, placebo-controlled randomized trials (Australian New Zealand Clinical Trials Registry, ACTRN12614001019695, ACTRN12615000173594) that investigated the efficacy and safety of oral omega-3 supplementation for treating ocular surface inflammation. Recruitment involved adults ( n = 105) with IOP <21 mm Hg, and without a current or prior glaucoma diagnosis. Participants were randomly allocated to either an oral omega-3 (∼1000 mg/day eicosapentaenoic acid + ∼500 mg/day docosahexaenoic acid ± 900 mg/day α-linolenic acid) or placebo (olive oil, 1500 mg/day) supplement. IOP was quantified at baseline and after 3 months of supplementation (day 90). Change in IOP, relative to baseline, was compared between groups. At baseline, participants were of similar age (omega-3/placebo groups: mean ± SEM, 33.7 ± 1.7, n = 72/35.6 ± 3.0 years, n = 33), sex (65%/79% female), and had similar IOP (14.3 ± 0.3/13.8 ± 0.5 mm Hg). At day 90, IOP was reduced to 13.6 ± 0.3 mm Hg in the omega-3 group; controls had a slight IOP increase to 14.2 ± 0.4 mm Hg ( P < 0.05). Oral omega-3 supplementation for 3 months significantly reduced IOP in normotensive adults. To our knowledge, this is the first study to report that omega-3 fatty acids lower IOP in humans. These findings justify further investigation into the therapeutic potential of omega-3 supplementation for reducing IOP, to prevent and/or treat conditions with IOP elevation, including ocular hypertension and glaucoma.

Production responses of Holstein dairy cows when fed supplemental fat containing saturated free fatty acids: a meta-analysis

PubMed Central

Hu, Wenping; Boerman, Jacquelyn P.; Aldrich, James M.

2017-01-01

Objective A meta-analysis was conducted to evaluate the effects of supplemental fat containing saturated free fatty acids (FA) on milk performance of Holstein dairy cows. Methods A database was developed from 21 studies published between 1991 and 2016 that included 502 dairy cows and a total of 29 to 30 comparisons between dietary treatment and control without fat supplementation. Only saturated free FA (>80% of total FA) was considered as the supplemental fat. Concentration of the supplemental fat was not higher than 3.5% of diet dry matter (DM). Dairy cows were offered total mixed ration, and fed individually. Statistical analysis was conducted using random- or mixed-effects models with Metafor package in R. Results Sub-group analysis showed that there were no differences in studies between randomized block design and Latin square/crossover design for dry matter intake (DMI) and milk production responses to the supplemental fat (all response variables, p≥0.344). The supplemental fat across all studies improved milk yield, milk fat concentration and yield, and milk protein yield by 1.684 kg/d (p<0.001), 0.095 percent unit (p = 0.003), 0.072 kg/d (p<0.001), and 0.036 kg/d (p<0.001), respectively, but tended to decrease milk protein concentration (mean difference = −0.022 percent unit; p = 0.063) while DMI (mean difference = 0.061 kg/d; p = 0.768) remained unchanged. The assessment of heterogeneity suggested that no substantial heterogeneity occurred among all studies for DMI and milk production responses to the supplemental fat (all response variables, I2≤24.1%; p≥0.166). Conclusion The effects of saturated free FA were quantitatively evaluated. Higher milk production and yields of milk fat and protein, with DMI remaining unchanged, indicated that saturated free FA, supplemented at ≤3.5% dietary DM from commercially available fat sources, likely improved the efficiency of milk production. Nevertheless, more studies are needed to assess the variation of

Military-specific application of nutritional supplements: a brief overview.

PubMed

Hoedebecke, Kyle; Brink, Will

2015-01-01

The Soldiers of America's military endure numerous physical and mental challenges that demand strict physical fitness regimens, extreme mental agility, and a perpetual readiness to deploy at a moment's notice. The chronicity of these stressors has the potential to dramatically reduce performance - both directly and indirectly.  Because of this risk, many Soldiers turn to nutritional supplements with hopes of optimizing performance. Increasing amounts of research have demonstrated that various supplements may enhance overall physical prowess, health, and offer quicker recovery in the face of corporal or psychological extremes. Most individuals, including many medical and nutrition professionals, possess only an elementary comprehension of nutritional supplements and their effect on Soldiers in training or combat environments. Nevertheless, a grasp of these details is required for safety and optimal benefits. Various compounds have been evaluated - to include evidence within the military setting - and found to augment endurance, increase cognitive function, decrease knee pain, or offer hearing or lung protection in the face of high-energy impulses. These efficacious outcomes may serve to augment the health and longevity of these Soldiers; however, continued research is needed for efficacy and long-term safety within specific environments.

Liver injury from herbal and dietary supplements.

PubMed

Navarro, Victor J; Khan, Ikhlas; Björnsson, Einar; Seeff, Leonard B; Serrano, Jose; Hoofnagle, Jay H

2017-01-01

Herbal and dietary supplements (HDS) are used increasingly both in the United States and worldwide, and HDS-induced liver injury in the United States has increased proportionally. Current challenges in the diagnosis and management of HDS-induced liver injury were the focus of a 2-day research symposium sponsored by the American Association for the Study of Liver Disease and the National Institutes of Health. HDS-induced liver injury now accounts for 20% of cases of hepatotoxicity in the United States based on research data. The major implicated agents include anabolic steroids, green tea extract, and multi-ingredient nutritional supplements. Anabolic steroids marketed as bodybuilding supplements typically induce a prolonged cholestatic but ultimately self-limiting liver injury that has a distinctive serum biochemical as well as histological phenotype. Green tea extract and many other products, in contrast, tend to cause an acute hepatitis-like injury. Currently, however, the majority of cases of HDS-associated liver injury are due to multi-ingredient nutritional supplements, and the component responsible for the toxicity is usually unknown or can only be suspected. HDS-induced liver injury presents many clinical and research challenges in diagnosis, identification of the responsible constituents, treatment, and prevention. Also important are improvements in regulatory oversight of nonprescription products to guarantee their constituents and ensure purity and safety. The confident identification of injurious ingredients within HDS will require strategic alignments among clinicians, chemists, and toxicologists. The ultimate goal should be to prohibit or more closely regulate potentially injurious ingredients and thus promote public safety. (Hepatology 2017;65:363-373). © 2016 by the American Association for the Study of Liver Diseases.

Safety Analysis of Panax Ginseng in Randomized Clinical Trials: A Systematic Review

PubMed Central

Kim, Young-Sook; Woo, Jung-Yoon; Han, Chang-Kyun; Chang, Il-Moo

2015-01-01

Background: Panax ginseng C.A. Meyer is one of the most frequently used herbs in the world. The roots of Panax ginseng have been used as a traditional tonic and medicine for thousands of years in Korea and China. Today, ginseng root is used as a dietary supplement and complementary medicine and for adjuvant therapeutics worldwide. The efficacy of ginseng has been studied in a wide range of basic research and clinical studies. However, it has been reported that the results from clinical studies are conflicting, and they depend on the parameters of the protocol design including the conditions of the participants and the types of ginseng used such as red ginseng, white ginseng, fermented ginseng and cultured ginseng. Meanwhile, in addition to clinical efficacy, the safety of ginseng is a highly important matter for customers. With globally increasing demand for Panax ginseng as a dietary supplement or complementary medicine, it is necessary to provide information on its safe use to customers to improve their health conditions. Although the safety of Panax ginseng in pre-clinical studies is well known, the evaluation of safety in clinical studies has so far been insufficient. This systematic review was conducted to assess the safety of ginseng in randomized controlled clinical trials (RCT) over the last 10 years. We chose the last 10 years because many clinical trials have been conducted in the past 10 years, and it will help to understand the recent trends in RCTs of ginseng. Methods: Articles on ginseng studies were searched with keywords in MEDLINE and four other Korean online database sites. Studies with ginseng as a monopreparation were selected while studies with single administration, preparations combined with other herbs or drug combinations were excluded from the selected studies. Data from the selected studies meeting the criteria were extracted and reviewed in terms of study design, condition and number of participants, type of ginseng, dosage, duration

A Study on Urban Road Traffic Safety Based on Matter Element Analysis

PubMed Central

Hu, Qizhou; Zhou, Zhuping; Sun, Xu

2014-01-01

This paper examines a new evaluation of urban road traffic safety based on a matter element analysis, avoiding the difficulties found in other traffic safety evaluations. The issue of urban road traffic safety has been investigated through the matter element analysis theory. The chief aim of the present work is to investigate the features of urban road traffic safety. Emphasis was placed on the construction of a criterion function by which traffic safety achieved a hierarchical system of objectives to be evaluated. The matter element analysis theory was used to create the comprehensive appraisal model of urban road traffic safety. The technique was used to employ a newly developed and versatile matter element analysis algorithm. The matter element matrix solves the uncertainty and incompatibility of the evaluated factors used to assess urban road traffic safety. The application results showed the superiority of the evaluation model and a didactic example was included to illustrate the computational procedure. PMID:25587267

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

To develop, implement, and evaluate team-based root cause analysis projects as part of a required medication safety course for second-year pharmacy students. Lectures, in-class activities, and out-of-class reading assignments were used to develop students' medication safety skills and introduce them to the culture of medication safety. Students applied these skills within teams by evaluating cases of medication errors using root cause analyses. Teams also developed error prevention strategies and formally presented their findings. Student performance was assessed using a medication errors evaluation rubric. Of the 211 students who completed the course, the majority performed well on root cause analysis assignments and rated them favorably on course evaluations. Medication error evaluation and prevention was successfully introduced in a medication safety course using team-based root cause analysis projects.

TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alan Bond

2001-04-01

This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

Supplements and other changes to an approved application. Final rule.

PubMed

2004-04-08

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

Investigation of safety analysis methods using computer vision techniques

NASA Astrophysics Data System (ADS)

Shirazi, Mohammad Shokrolah; Morris, Brendan Tran

2017-09-01

This work investigates safety analysis methods using computer vision techniques. The vision-based tracking system is developed to provide the trajectory of road users including vehicles and pedestrians. Safety analysis methods are developed to estimate time to collision (TTC) and postencroachment time (PET) that are two important safety measurements. Corresponding algorithms are presented and their advantages and drawbacks are shown through their success in capturing the conflict events in real time. The performance of the tracking system is evaluated first, and probability density estimation of TTC and PET are shown for 1-h monitoring of a Las Vegas intersection. Finally, an idea of an intersection safety map is introduced, and TTC values of two different intersections are estimated for 1 day from 8:00 a.m. to 6:00 p.m.

Developing a research agenda for patient safety in primary care. Background, aims and output of the LINNEAUS collaboration on patient safety in primary care.

PubMed

Esmail, Aneez; Valderas, Jose M; Verstappen, Wim; Godycki-Cwirko, Maciek; Wensing, Michel

2015-09-01

This paper is an introduction to a supplement to The European Journal of General Practice, bringing together a body of research focusing on the issue of patient safety in relation to primary care. The supplement represents the outputs of the LINNEAUS collaboration on patient safety in primary care, which was a four-year (2009-2013) coordination and support action funded under the Framework 7 programme by the European Union. Being a coordination and support action, its aim was not to undertake new research, but to build capacity through engaging primary care researchers and practitioners in identifying some of the key challenges in this area and developing consensus statements, which will be an essential part in developing a future research agenda. This introductory article describes the aims of the LINNEAUS collaboration, provides a brief summary of the reasons to focus on patient safety in primary care, the epidemiological and policy considerations, and an introduction to the papers included in the supplement.

Developing a research agenda for patient safety in primary care. Background, aims and output of the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Esmail, Aneez; Valderas, Jose M.; Verstappen, Wim; Godycki-Cwirko, Maciek; Wensing, Michel

2015-01-01

ABSTRACT This paper is an introduction to a supplement to The European Journal of General Practice, bringing together a body of research focusing on the issue of patient safety in relation to primary care. The supplement represents the outputs of the LINNEAUS collaboration on patient safety in primary care, which was a four-year (2009–2013) coordination and support action funded under the Framework 7 programme by the European Union. Being a coordination and support action, its aim was not to undertake new research, but to build capacity through engaging primary care researchers and practitioners in identifying some of the key challenges in this area and developing consensus statements, which will be an essential part in developing a future research agenda. This introductory article describes the aims of the LINNEAUS collaboration, provides a brief summary of the reasons to focus on patient safety in primary care, the epidemiological and policy considerations, and an introduction to the papers included in the supplement. PMID:26339828

Re: errors in the NOF meta-analysis of calcium and vitamin D supplements

USDA-ARS?s Scientific Manuscript database

The manuscript entitled "Calcium plus vitamin D supplementation and risk of fractures: an updated meta-analysis from the National Osteoporosis Foundation" sought to update a former AHRQ evidence report. The study was commissioned by the NOF to inform the organization, since a significant controversy...

Vitamin D Safety and Requirements

PubMed Central

de Paula, Francisco J.A.; Rosen, Clifford J.

2011-01-01

Vitamin D an ancient secosteroid is essential for mineral homeostasis, bone remodeling, immune modulation, and energy metabolism. Recently, debates have emerged about the daily vitamin D requirements for healthy and elderly adults, the safety and efficacy of long term supplementation and the role of vitamin D deficiency in several chronic disease states. Since this molecule acts as both a vitamin and a hormone, it should not be surprising that the effects of supplementation are multi-faceted and complex. Yet despite significant progress in the last decade, our understanding of vitamin D physiology and the clinical relevance of low circulating levels of this vitamin remains incomplete. The present review provides the reader with a comprehensive and up-to-date understanding of vitamin D requirements and safety. It also raises some provocative research questions. PMID:22179017

[Regulation of food supplements in the European Union and its member states. Part I].

PubMed

Petrenko, A S; Ponomareva, M N; Sukhanov, B P

2014-01-01

The article discusses aspects of the regional (the European Union) and national (European countries) regulation of food supplements. The definition of the supplement category is given. The contemporary issues of nutrition in developed countries are discussed, and the essential role of food supplements in the diet is emphasized. In particular, the use of vitamins, minerals, botanicals and their chemical constituents in food supplements as well as the issue of setting maximum daily limits are discussed. The positive lists of vitamins, minerals and their chemical modifications are presented. The paper also outlines aspects of supplement safety, requirements for their labelling and pre-market notification procedure.

Motorcoach and school bus fire safety analysis : technology brief.

DOT National Transportation Integrated Search

2016-11-01

In 2009, the Federal Motor Carrier Safety Administration (FMCSA) published findings from a study entitled Motorcoach Fire Safety Analysis. The objective of this study was to gather and analyze information regarding the causes, frequency, and se...

Impact of supplemental instruction leader on the success of supplemental instruction model

NASA Astrophysics Data System (ADS)

Mahabaduge, Hasitha; Haslam, Jeanne

Supplemental instruction utilizes peer-assisted study sessions to provide review sessions on course material and an opportunity to discuss and work out problems. The impact of supplemental instruction on student performance is well researched and used in a large number of universities around the world due to its proven success. However, the impact of the student leader who plays a significant role in this model is rarely discussed in the literature. We present a case study on the impact of student leader on the success of supplemental instruction model. This case study was done for an Introductory Physics course correlating student performance and the supplemental instruction sessions they attended. Further analysis revealed that the academic performance and work ethics of the student leader has a significant impact on the success of the supplemental instruction model. Important factors to consider when selecting a student leader, the challenges and possible remedies will also be discussed.

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2014 CFR

2014-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2013 CFR

2013-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2010 CFR

2010-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2011 CFR

2011-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2012 CFR

2012-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

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.

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a) (1) The applicant must analyze the engine, including the control system, to assess the likely...

Hazard Analysis and Safety Requirements for Small Drone Operations: To What Extent Do Popular Drones Embed Safety?

PubMed

Plioutsias, Anastasios; Karanikas, Nektarios; Chatzimihailidou, Maria Mikela

2018-03-01

Currently, published risk analyses for drones refer mainly to commercial systems, use data from civil aviation, and are based on probabilistic approaches without suggesting an inclusive list of hazards and respective requirements. Within this context, this article presents: (1) a set of safety requirements generated from the application of the systems theoretic process analysis (STPA) technique on a generic small drone system; (2) a gap analysis between the set of safety requirements and the ones met by 19 popular drone models; (3) the extent of the differences between those models, their manufacturers, and the countries of origin; and (4) the association of drone prices with the extent they meet the requirements derived by STPA. The application of STPA resulted in 70 safety requirements distributed across the authority, manufacturer, end user, or drone automation levels. A gap analysis showed high dissimilarities regarding the extent to which the 19 drones meet the same safety requirements. Statistical results suggested a positive correlation between drone prices and the extent that the 19 drones studied herein met the safety requirements generated by STPA, and significant differences were identified among the manufacturers. This work complements the existing risk assessment frameworks for small drones, and contributes to the establishment of a commonly endorsed international risk analysis framework. Such a framework will support the development of a holistic and methodologically justified standardization scheme for small drone flights. © 2017 Society for Risk Analysis.

Folic acid supplements and colorectal cancer risk: meta-analysis of randomized controlled trials

NASA Astrophysics Data System (ADS)

Qin, Tingting; Du, Mulong; Du, Haina; Shu, Yongqian; Wang, Meilin; Zhu, Lingjun

2015-07-01

Numerous studies have investigated the effects of folic acid supplementation on colorectal cancer risk, but conflicting results were reported. We herein performed a meta-analysis based on relevant studies to reach a more definitive conclusion. The PubMed and Embase databases were searched for quality randomized controlled trials (RCTs) published before October 2014. Eight articles met the inclusion criteria and were subsequently analyzed. The results suggested that folic acid treatment was not associated with colorectal cancer risk in the total population (relative risk [RR] = 1.00, 95% confidence interval [CI] = 0.82-1.22, P = 0.974). Moreover, no statistical effect was identified in further subgroup analyses stratified by ethnicity, gender, body mass index (BMI) and potential confounding factors. No significant heterogeneity or publication bias was observed. In conclusion, our meta-analysis demonstrated that folic acid supplementation had no effect on colorectal cancer risk. However, this finding must be validated by further large studies.

NASA Safety and Health (Short Form). Final rule

NASA Technical Reports Server (NTRS)

2001-01-01

This final rule adopts with changes the interim rule published in the Federal Register on April 5, 2001 (65 FR 18051-18053), which amended the NASA FAR Supplement to implement a Safety and Health (Short Form) clause to address safety and occupational health in all NASA contracts above the micro-purchase threshold where the existing Safety and Health clause did not apply, and amended other safety and health clauses to be consistent with the new NASA Safety and Health (Short Form) clause.

Evaluation of internet websites marketing herbal weight-loss supplements to consumers.

PubMed

Jordan, Melanie A; Haywood, Tasha

2007-11-01

The aim of this study was to evaluate the quality and quantity of drug information available to consumers on Internet websites marketing herbal weight-loss dietary supplements in the United States. We conducted an Internet search using the search engines Yahoo and Google and the keywords "herbal weight loss." Website content was evaluated for the presence of active/inactive ingredient names and strengths and other Food and Drug Administration (FDA) labeling requirements. Information related to drug safety for the most common herbal ingredients in the products evaluated was compared against standard herbal drug information references. Thirty-two (32) websites were evaluated for labeling requirements and safety information. All sites listed an FDA disclaimer statement and most sites (84.4%) listed active ingredients, although few listed strengths or inactive ingredients. Based on the drug information for the most common ingredients found in the weight-loss dietary supplements evaluated, potential contraindications for cardiovascular conditions, pregnancy/nursing, and high blood pressure were listed most frequently (73%, 65.5%, and 37%, respectively), whereas few websites listed potential drug interactions or adverse reactions. Potential hazards posed by dietary supplements may not be accurately, if at all, represented on Internet websites selling these products. Since consumers may not approach their physicians or pharmacists for information regarding use of dietary supplements in weight loss, it becomes necessary for health care providers to actively engage their patients in open discussion regarding the use, benefits, and hazards of dietary supplements.

Random safety auditing, root cause analysis, failure mode and effects analysis.

PubMed

Ursprung, Robert; Gray, James

2010-03-01

Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.

Gluten screening of several dietary supplements by immunochromatographic assay.

PubMed

Oancea, Simona; Wagner, Adriana; Cîrstea, Elena; Sima, Mirela

2011-01-01

Celiac disease (CD) is a chronic intestinal disorder of public health concern caused by gluten ingestion in sensitive individuals. Gluten is a protein found not only in gluten-containing food but also as normal component of drugs and dietary supplements. Detection of gluten in dietary supplements is a very important task required for establishing their gluten status, which is highly important for the safety of products consumed by CD and gluten-sensitive patients. In this paper, we investigated the presence of gluten in twenty one common dietary supplements from the national market using the immunochromatographic assay. This visual assay proved to be an efficient rapid tool for gluten screening as an alternative to the ELISA techniques. The results have shown the presence of gluten in 23.8% of the investigated samples (vitamins, minerals, plant extracts, probiotics supplements, lactoferrin, propolis supplements). The results provide information which may contribute to the completion of the existing lists of gluten-free pharmaceuticals. It is known that for CD patients obtaining accurate information about the gluten content of a particular item is a difficult and time-consuming process.

Safety effects of traffic signing for left turn flashing yellow arrow signals.

PubMed

Schattler, Kerrie L; Gulla, Cody J; Wallenfang, Travis J; Burdett, Beau A; Lund, Jessica A

2015-02-01

In 2010, the left turn flashing yellow arrow (FYA) signal displays were installed at signalized intersections on state routes in the Peoria, Illinois, area. Supplemental traffic signs with text "Left Turn Yield on Flashing Yellow Arrow" were mounted on the mast arm adjacent to the left turn signal at over half of the FYA installations. The purpose of this paper is to present the results of the effectiveness evaluation of the FYA supplemental sign on safety. Analyses are presented on the effects of the FYA supplemental sign for all drivers and a subset of drivers age 65 and older. A crash-based comparison of 164 FYA approaches including 90 approaches with the sign and 74 approaches without the sign showed greater crash reductions when the supplemental FYA sign was present. The results also showed that crashes involving drivers age 65 and older did not experience the same magnitudes of crash reductions as compared to all drivers. The findings of this research indicate that supplemental FYA signs may help in improving safety for left-turning vehicles during the permissive interval. Thus, it is recommended that supplemental signs be used when initially implementing the FYA, and that effort to educate the driving public on new traffic control be made to further improve safety at signalized intersections. Copyright © 2014. Published by Elsevier Ltd.

Hepatoxicity associated with weight-loss supplements: a case for better post-marketing surveillance.

PubMed

Lobb, Ano

2009-04-14

There is a growing number of case reports of hepatoxicity from the widely marketed weight-loss supplement Hydroxycut, which contains the botanical ingredient Garcinia cambogia. These case reports may substantially undercount the true magnitude of harm. Based on the past experience with harmful dietary supplements, US regulators should assume the more precautionary approach favored by Canada and Europe. Lacking effective adverse event surveillance for supplements, or the requirements to prove safety prior to coming to the market, case reports such as those summarized here assume added importance.

Efficacy of Probiotic Supplementation Therapy for Helicobacter pylori Eradication: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Deng, Jiaqi; Yan, Qiong; Yang, Chun; Xia, Guodong; Zhou, Xian

2016-01-01

Background Traditional Helicobacter pylori (H. pylori) eradication therapies have shown efficacies below 80% in several studies, and their use has been accompanied by antibiotic-related side effects. Some recent studies have reported that supplementing standard therapies with probiotics can improve the efficacy and tolerability of Helicobacter pylori eradication therapy. Objective To assess the effects of probiotic supplementation on the eradication rates and therapy-related adverse event rates of anti-Helicobacter pylori regimens. Methods We searched PubMed, Medline, the Cochrane Central Registry of Controlled Trials and the Chinese Biomedical Database for eligible randomized controlled trials published through July, 2015. Review Manager 5.3 was used for all statistical analyses. Results Thirteen randomized controlled trials involving a total of 2306 patients were included in our analysis. Intent-to-treat (ITT) analysis performed using a fixed-effects model (test for heterogeneity I2 = 45%) showed that the pooled relative risk (RR) of eradication was significantly higher in the probiotic supplementation group than in the control group [RR 1.15, 95% confidence interval (CI): 1.10–1.20, P<0.00001]. The incidence of total antibiotic-related side effects was lower in the probiotic supplementation group than in the control group, and the pooled RR (studies n = 9) was 0.71 (95% CI: 0.54–0.94, P = 0.02), as determined using a random-effects model (heterogeneity test I2 = 59%). Certain adverse events, such as nausea and vomiting (RR = 0.58, 95% CI 0.35–0.95, P = 0.03), diarrhea (RR = 0.51, 95% CI: 0.31–0.84, P = 0.008) and constipation (RR = 0.47, 95% CI: 0.28–0.80, P = 0.005), were reported at lower rates in the probiotic supplementation group than in the control group. Subgroup analysis showed that eradication rates were significantly improved in both adults (RR = 1.14, 95% CI: 1.09–1.19, P<0.00001) and children (RR = 1.24, 95% CI: 1.05–1.47, P = 0.01) in

Mutagenicity and Acute Oral Toxicity Test for Herbal Poultry Feed Supplements.

PubMed

Srinivasa Rao, Boddapati; Chandrasekaran, C V; Srikanth, H S; Sasikumar, Murugan; Edwin Jothie, R; Haseena, Begum; Bharathi, Bethapudi; Selvam, Ramasamy; Prashanth, D'Souza

2018-01-01

Herbal products are being used and trusted globally for thousands of years for their health benefits and limited side effects. Globally, a general belief amongst the consumers is that herbal supplements are always safe because they are "natural." But later, research reveals that they may not be safe. This raises concern on their safety and implications for their use as feed supplement or medicine. Toxicity testing can reveal some of the risks that may be associated with use of herbs, therefore avoiding potential harmful effects. The present study was designed to investigate five poultry feed supplements (PFS), EGMAX® (to revitalize ovarian activity), FEED-X ™ (feed efficiency enhancer), KOLIN PLUS ™ (natural replacer of synthetic choline chloride), PHYTOCEE® (natural defence enhancer), and STODI® (to prevent and control loose droppings), for their possible mutagenicity and toxicity. Bacterial reverse mutation (BRMT) and acute oral toxicity tests were employed to assess the PFS for their possible mutagenicity and toxicity. Results indicated that the PFS were devoid of mutagenic effects in BRMT and showed higher safety profile in rodent acute oral toxicity test.

The silicon supplement ‘Monomethylsilanetriol’ is safe and increases the body pool of silicon in healthy Pre-menopausal women

PubMed Central

2013-01-01

Background Monomethylsilanetriol (MMST) has been used for decades as an oral silicon supplement for bone and connective tissue health, although there are no formal data on its in vivo utilisation or safety following sustained dosing. Methods To investigate whether MMST contributes to the body pool of silicon and, secondly, to establish its safety following 4 weeks’ supplementation in humans, twenty-two healthy pre-menopausal women (22–38 years) were recruited and supplemented with MMST at the maximum daily recommended dose (10.5 mg Si/day) for 4 weeks in a double-blind, randomised, placebo-controlled, cross-over design (i.e. 8 weeks in total). Fasting serum and urine samples were collected at baseline and at the end of the 4-week supplementation/placebo periods for analysis of total silicon by inductively coupled plasma optical emission spectrometry, MMST by proton nuclear magnetic resonance spectroscopy and full serum biochemistry. Participants also reported on, by questionnaire, their health, well-being and quality of life at 0, 4 and 8 weeks. Results Overall, 4-weeks supplementation with MMST significantly increased total fasting Si concentrations in serum and urine (P ≤ 0.003; paired t-test). MMST was semi-quantifiable in serum and quantifiable in urine, but only accounted for ca. 50% and 10%, respectively, of the increased total-Si concentration. There were no reported adverse effects (i.e. changes to health and well-being) or serum biochemical changes with MMST versus placebo. Conclusions Our data indicate that oral MMST is safe, is absorbed and undergoes sufficient metabolism in vivo to raise fasting serum silicon levels, consistent with other well absorbed forms of dietary silicon (e.g. orthosilicic acid). It thus appears to be a suitable silicon supplement. PMID:23622499

Microbial food safety in Ghana: a meta-analysis.

PubMed

Saba, Courage K S; Gonzalez-Zorn, Bruno

2012-12-16

Food safety is a crucial factor in the growth of developing countries worldwide. In this study, we present a meta-analysis of microbiological food safety publications from Ghana. The search words "Ghana food safety", "Ghana food research", and "Ghana food bacteria" were used to search for microbiological food safety publications with related abstracts or titles in PubMed, published between 1997 and 2009. We obtained 183 research articles, from which we excluded articles concerning ready-to-eat microbial fermented foods and waterborne microorganisms as well as articles without abstracts. The criteria used for analysis of these publications were based on an assessment of methodological soundness previously developed for use in the medical field, with some modifications incorporated. The most predominant bacteria in Ghanain foods are Enterobacter spp., Citrobacter spp., Klebsiella spp. and Escherichia spp., which were found to be present in 65%, 50%, 46% and 38% respectively, of the food samples considered in the studies analysed. The most contaminated food samples were macaroni, salad, and milk. Although the methodological quality of the articles was generally sound, most of them did not give directions for future research. Several did not state possible reasons for differences between studies. The microbiological food contamination in Ghana is alarming. However, we found that the downward trend in publications of microbial food safety articles is appalling. Hence a concerted effort in research on food safety is needed in Ghana to help curb the incidence of preventable food-borne disease.

Meta-analysis: protein and energy supplementation in older people.

PubMed

Milne, Anne C; Avenell, Alison; Potter, Jan

2006-01-03

Protein and energy undernutrition is common in older people, and further deterioration may occur during illness. To assess whether oral protein and energy supplementation improves clinical and nutritional outcomes for older people in the hospital, in an institution, or in the community. Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, HealthStar, CINAHL, BIOSIS, and CAB abstracts. The authors included English- and non-English-language studies and hand-searched journals, contacted manufacturers, and sought information from trialists. The date of the most recent search of CENTRAL and MEDLINE is June 2005. Randomized and quasi-randomized controlled trials of oral protein and energy supplementation compared with placebo or control treatment in older people. Two reviewers independently assessed trials for inclusion, extracted data, and assessed trial quality. Differences were resolved by consensus. Fifty-five trials were included (n = 9187 randomly assigned participants). For patients in short-term care hospitals who were given oral supplements, evidence suggested fewer complications (Peto odds ratio, 0.72 [95% CI, 0.53 to 0.97]) and reduced mortality (Peto odds ratio, 0.66 [CI, 0.49 to 0.90]) for those undernourished at baseline. Few studies reported evidence that suggested any change in mortality, morbidity, or function for those given supplements at home. Ten trials reported gastrointestinal disturbances, such as nausea, vomiting, and diarrhea, with oral supplements. The quality of most studies, as reported, was poor, particularly for concealment of allocation and blinding of outcome assessors. Many studies were too small or the follow-up time was too short to detect a statistically significant change in clinical outcome. The clinical results are dominated by 1 very large recent trial in patients with stroke. Although this was a high-quality trial, few participants were undernourished at baseline. Oral nutritional supplements can improve

Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

NASA Technical Reports Server (NTRS)

Babcock, P.; Schor, A.; Rosch, G.

1998-01-01

This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

Galileo and Ulysses missions safety analysis and launch readiness status

NASA Technical Reports Server (NTRS)

Cork, M. Joseph; Turi, James A.

1989-01-01

The Galileo spacecraft, which will release probes to explore the Jupiter system, was launched in October, 1989 as the payload on STS-34, and the Ulysses spacecraft, which will fly by Jupiter en route to a polar orbit of the sun, is presently entering system-test activity in preparation for an October, 1990 launch. This paper reviews the Galileo and Ulysses mission objectives and design approaches and presents details of the missions' safety analysis. The processes used to develop the safety analysis are described and the results of safety tests are presented.

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

Evaluation of the safety performance of highway alignments based on fault tree analysis and safety boundaries.

PubMed

Chen, Yikai; Wang, Kai; Xu, Chengcheng; Shi, Qin; He, Jie; Li, Peiqing; Shi, Ting

2018-05-19

To overcome the limitations of previous highway alignment safety evaluation methods, this article presents a highway alignment safety evaluation method based on fault tree analysis (FTA) and the characteristics of vehicle safety boundaries, within the framework of dynamic modeling of the driver-vehicle-road system. Approaches for categorizing the vehicle failure modes while driving on highways and the corresponding safety boundaries were comprehensively investigated based on vehicle system dynamics theory. Then, an overall crash probability model was formulated based on FTA considering the risks of 3 failure modes: losing steering capability, losing track-holding capability, and rear-end collision. The proposed method was implemented on a highway segment between Bengbu and Nanjing in China. A driver-vehicle-road multibody dynamics model was developed based on the 3D alignments of the Bengbu to Nanjing section of Ning-Luo expressway using Carsim, and the dynamics indices, such as sideslip angle and, yaw rate were obtained. Then, the average crash probability of each road section was calculated with a fixed-length method. Finally, the average crash probability was validated against the crash frequency per kilometer to demonstrate the accuracy of the proposed method. The results of the regression analysis and correlation analysis indicated good consistency between the results of the safety evaluation and the crash data and that it outperformed the safety evaluation methods used in previous studies. The proposed method has the potential to be used in practical engineering applications to identify crash-prone locations and alignment deficiencies on highways in the planning and design phases, as well as those in service.

Effects of probiotic supplementation over 5 months on routine haematology and clinical chemistry measures in healthy active adults.

PubMed

Cox, A J; West, N P; Horn, P L; Lehtinen, M J; Koerbin, G; Pyne, D B; Lahtinen, S J; Fricker, P A; Cripps, A W

2014-11-01

Use of probiotic-containing foods and probiotic supplements is increasing; however, few studies document safety and tolerability in conjunction with defined clinical end points. This paper reports the effects of 150 days of supplementation with either a single- (Bifidobacterium animalis subsp. lactis Bl-04) or a double-strain (Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07) probiotic on routine haematology and clinical chemistry measures in healthy active adults. Pre- to post-intervention changes in laboratory measures were determined and compared between supplement and placebo groups. Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention. Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges. These data provide evidence supporting the use of these probiotic supplements over a period of 5 months in healthy active adults without obvious safety or tolerability issues.

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements

PubMed Central

Sprouse, Alyssa A.

2016-01-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug–botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John’s wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug–botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug–botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. PMID:26438626

Alternative antimicrobial supplements that positively impact animal health and food safety.

USDA-ARS?s Scientific Manuscript database

Antibiotic usage is a common practice in the livestock industry that has progressively gained attention from consumers of livestock products in regard to human and environmental health. Specifically, sub-therapeutic usage of antibiotics and the belief that prophylactic supplementation leads to anti...

Improving safety in small enterprises through an integrated safety management intervention.

PubMed

Kines, Pete; Andersen, Dorte; Andersen, Lars Peter; Nielsen, Kent; Pedersen, Louise

2013-02-01

This study tests the applicability of a participatory behavior-based injury prevention approach integrated with safety culture initiatives. Sixteen small metal industry enterprises (10-19 employees) are randomly assigned to receive the intervention or not. Safety coaching of owners/managers result in the identification of 48 safety tasks, 85% of which are solved at follow-up. Owner/manager led constructive dialogue meetings with workers result in the prioritization of 29 tasks, 79% of which are accomplished at follow-up. Intervention enterprises have significant increases on six of eight safety-perception-survey factors, while comparisons increase on only one factor. Both intervention and comparison enterprises demonstrate significant increases in their safety observation scores. Interview data validate and supplement these results, providing some evidence for behavior change and the initiation of safety culture change. Given that over 95% of enterprises in most countries have less than 20 employees, there is great potential for adapting this integrated approach to other industries. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

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

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

Understanding the properties of common dietary supplements: clinical implications for healthcare practitioners.

PubMed

Zelig, Rena; Rigassio Radler, Diane

2012-12-01

Dietary supplement usage in the United States continues to increase. This article explores the background of dietary supplements and their regulations, discusses trends in usage patterns highlighting the properties of 10 popular dietary supplements, addresses safety concerns and drug-nutrient interactions, and discusses the role of the healthcare professional in assessing and recommending usage of dietary supplements. The authors reviewed the literature on dietary supplementation. Government websites were used to obtain background and regulatory information. Evidence-based databases were used to summarize popular dietary supplements in terms of their common uses, mechanisms of action, and clinical implications. The related literature was reviewed to discuss important factors for the healthcare professional to consider as well as the role of the healthcare professional in integrating dietary supplement use within patient care. Healthcare professionals need to be prepared to evaluate dietary supplement usage and make appropriate recommendations for an individualized plan of care. As the popularity of dietary supplements continues to grow, healthcare professionals will need to communicate with patients about their usage; educate themselves on their potential benefits, interactions, and contraindications; evaluate the literature; make recommendations; and document appropriately in a comprehensive and integrated plan of care.

Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance

PubMed Central

Lobb, Ano

2009-01-01

There is a growing number of case reports of hepatoxicity from the widely marketed weight-loss supplement Hydroxycut, which contains the botanical ingredient Garcinia cambogia. These case reports may substantially undercount the true magnitude of harm. Based on the past experience with harmful dietary supplements, US regulators should assume the more precautionary approach favored by Canada and Europe. Lacking effective adverse event surveillance for supplements, or the requirements to prove safety prior to coming to the market, case reports such as those summarized here assume added importance. PMID:19360927

Special Education/Traffic Safety Education. Curriculum Guide.

ERIC Educational Resources Information Center

McBrayer, Clyde; Tidwell, Fred

The curriculum guide for special education students is intended to serve as a supplement to the Washington 1980 State Traffice Safety Education Curriculum Guide. The guide is also correlated with two popular traffic safety texts. Each of the 21 modules contains a goal statement, a list of vocabulary words that might be difficult, a check sheet…

Oral isoflavone supplementation on endometrial thickness: a meta-analysis of randomized placebo-controlled trials

PubMed Central

Liu, Jie; Yuan, Feixiang; Gao, Jian; Shan, Boer; Ren, Yulan; Wang, Huaying; Gao, Ying

2016-01-01

Background Isoflavone from soy and other plants modulate hormonal effects in women, and the hormone disorder might result in different caners including endometrial cancer. However, it's effect on the risk of endometrial cancer is still inconclusive. We aimed to assess the effects of isoflavone on endometrial thickness, a risk factor of endometrial cancer in peri- and post-menopausal women. Methods A meta-analysis of randomized controlled trials was conducted to evaluate the effect of oral isoflavone supplementation on endometrial thickness in peri- and post-menopausal women. Electronic searches were performed on the PubMed, Embase, the Cochrane Library, web of science, CINAHL, and WHO ICTRP to August 1st, 2015. Reviews and reference lists of relevant articles were also searched to identify more studies. Summary estimates of standard mean differences (SMD's) and 95%CIs were obtained with random-effects models. Heterogeneity was evaluated with meta-regression and stratified analyses. Results A total of 23 trials were included in the current analysis. The overall results did not show significant change of endometrial thickness after oral isoflavone supplementation (23 studies, 2167subjects; SMD:-0.05; 95%CI:-0.23, 0.13; P=0.60). Stratified analysis suggested that a daily dose of more than 54mg could decrease the endometrial thickness for 0.26mm (10 trials, 984subjects; SMD:-0.26; 95%CI:-0.45, −0.07; P=0.007). Furthermore, isoflavone supplementation significantly decrease the endometrial thickness for 0.23mm in North American studies (7 trials, 726 subjects; SMD:-0.23; 95%CI:-0.44, −0.01; P=0.04), but it suggested an increase for 0.23mm in Asian studies (3 trials, 224 subjects; SMD: 0.23; 95%CI:-0.04, 0.50; P=0.10). Conclusion Oral isoflavone supplementation might have different effects in different populations and at different daily doses. Multiple-centre, larger, and long-term trials are deserved to further evaluate its effect. PMID:26967050

Probabilistic safety analysis of earth retaining structures during earthquakes

NASA Astrophysics Data System (ADS)

Grivas, D. A.; Souflis, C.

1982-07-01

A procedure is presented for determining the probability of failure of Earth retaining structures under static or seismic conditions. Four possible modes of failure (overturning, base sliding, bearing capacity, and overall sliding) are examined and their combined effect is evaluated with the aid of combinatorial analysis. The probability of failure is shown to be a more adequate measure of safety than the customary factor of safety. As Earth retaining structures may fail in four distinct modes, a system analysis can provide a single estimate for the possibility of failure. A Bayesian formulation of the safety retaining walls is found to provide an improved measure for the predicted probability of failure under seismic loading. The presented Bayesian analysis can account for the damage incurred to a retaining wall during an earthquake to provide an improved estimate for its probability of failure during future seismic events.

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

14 CFR 33.75 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... judgment and previous experience combined with sound design and test philosophies. (4) The applicant must... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.75 Safety analysis. (a... the effects of failures and likely combination of failures be verified by test. (c) The primary...

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

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.

Protein Supplements: Pros and Cons.

PubMed

Samal, Jay Rabindra Kumar; Samal, Indira R

2018-05-04

To provide a comprehensive analysis of the literature examining the pros and cons of protein supplementation, various articles on protein supplementation were obtained from Google Scholar, PubMed, and National Center for Biotechnology Information. Over the past few years, protein supplementation has become commonplace for gym-goers as well as for the public. A large segment of the general population relies on protein supplementation for meal replacement, weight reduction, and purported health benefits. These protein supplements have varying pros and cons associated with them, which are often overlooked by the public. This review aims to assimilate existing studies and form a consensus regarding the benefits and disadvantages of protein supplementation. The purported health benefits of protein supplementation have led to overuse by both adults and adolescents. Although the pros and cons of protein supplementation is a widely debated topic, not many studies have been conducted regarding the same. The few studies that exist either provide insufficient evidence or have not employed proper conditions for the conduct of the tests. It should be considered that protein supplements are processed materials and often do not contain other essential nutrients required for the sustenance of a healthy lifestyle. It is suggested that the required protein intake should be obtained from natural food sources and protein supplementation should be resorted to only if sufficient protein is not available in the normal diet.

A supplemental catalog of atmospheric densities from satellite-drag analysis

NASA Technical Reports Server (NTRS)

Jacchia, L. G.; Slowey, J. W.

1972-01-01

The catalog of densities derived from satellite-drag analysis extends and supplements similar earlier publications. The densities were computed from nine artificial satellites for effective heights ranging from 300 to 1130 km, and are presented together with pertinent data that permit the location in time and space of the point to which they refer. The intervals covered vary between 1 and 6 years for the different satellites and average about 3.5 years for the nine satellites. The cutoff date for the data included is, in most cases, January 14, 1970.

Study of dietary supplements compositions by neutron activation analysis at the VR-1 training reactor

NASA Astrophysics Data System (ADS)

Stefanik, Milan; Rataj, Jan; Huml, Ondrej; Sklenka, Lubomir

2017-11-01

The VR-1 training reactor operated by the Czech Technical University in Prague is utilized mainly for education of students and training of various reactor staff; however, R&D is also carried out at the reactor. The experimental instrumentation of the reactor can be used for the irradiation experiments and neutron activation analysis. In this paper, the neutron activation analysis (NAA) is used for a study of dietary supplements containing the zinc (one of the essential trace elements for the human body). This analysis includes the dietary supplement pills of different brands; each brand is represented by several different batches of pills. All pills were irradiated together with the standard activation etalons in the vertical channel of the VR-1 reactor at the nominal power (80 W). Activated samples were investigated by the nuclear gamma-ray spectrometry technique employing the semiconductor HPGe detector. From resulting saturated activities, the amount of mineral element (Zn) in the pills was determined using the comparative NAA method. The results show clearly that the VR-1 training reactor is utilizable for neutron activation analysis experiments.

Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements.

PubMed

Schilter, B; Andersson, C; Anton, R; Constable, A; Kleiner, J; O'Brien, J; Renwick, A G; Korver, O; Smit, F; Walker, R

2003-12-01

There is a growing interest by both consumers and industry for the development of food products with 'functional' properties, or health benefits. These products may take the form of dietary supplements or of foods. The health benefits are given by particular ingredients, and in many cases these are derived from botanicals. The variety of plants providing these functions is large, ranging from staple food sources such as cereals, fruits and vegetables, to herbals as used in traditional medicine. The food or ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components. The present report discusses the data required to determine the safe use of these types of ingredients, and provides advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterisation of standardised and authentic materials, documented history of use and comparison to existing products (taking into account the effect of industrial processing), description of the intended use and consequent exposure are highlighted as key background information on which to base a risk evaluation. The extent of experimental investigation required, such as in vitro, animal, and/or human studies, depends on the adequacy of this information. A decision tree is presented as an aid to determine the extent of data requirements based on product comparison. The ultimate safety in use depends on the establishment of an adequate safety margin between expected exposure and identified potential hazards. Health hazards may arise from inherent toxicities or contaminants of the plant materials, including the mechanism of the intended beneficial effect. A lower safety margin may therefore be expected

Model-Driven Safety Analysis of Closed-Loop Medical Systems

PubMed Central

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2013-01-01

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PMID:24177176

Model-Driven Safety Analysis of Closed-Loop Medical Systems.

PubMed

Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup

2012-10-26

In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure.

Nitrate supplementation improves physical performance specifically in non-athletes during prolonged open-ended tests: a systematic review and meta-analysis.

PubMed

Campos, Helton O; Drummond, Lucas R; Rodrigues, Quezia T; Machado, Frederico S M; Pires, Washington; Wanner, Samuel P; Coimbra, Cândido C

2018-03-01

Nitrate (NO3 -) is an ergogenic nutritional supplement that is widely used to improve physical performance. However, the effectiveness of NO3 - supplementation has not been systematically investigated in individuals with different physical fitness levels. The present study analysed whether different fitness levels (non-athletes v. athletes or classification of performance levels), duration of the test used to measure performance (short v. long duration) and the test protocol (time trials v. open-ended tests v. graded-exercise tests) influence the effects of NO3 - supplementation on performance. This systematic review and meta-analysis was conducted and reported according to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. A systematic search of electronic databases, including PubMed, Web of Science, SPORTDiscus and ProQuest, was performed in August 2017. On the basis of the search and inclusion criteria, fifty-four and fifty-three placebo-controlled studies evaluating the effects of NO3 - supplementation on performance in humans were included in the systematic review and meta-analysis, respectively. NO3 - supplementation was ergogenic in non-athletes (mean effect size (ES) 0·25; 95 % CI 0·11, 0·38), particularly in evaluations of performance using long-duration open-ended tests (ES 0·47; 95 % CI 0·23, 0·71). In contrast, NO3 - supplementation did not enhance the performance of athletes (ES 0·04; 95 % CI -0·05, 0·15). After objectively classifying the participants into different performance levels, the frequency of trials showing ergogenic effects in individuals classified at lower levels was higher than that in individuals classified at higher levels. Thus, the present study indicates that dietary NO3 - supplementation improves physical performance in non-athletes, particularly during long-duration open-ended tests.

Dietary supplements and human health: for better or for worse?

PubMed

Jerome-Morais, Anita; Diamond, Alan M; Wright, Margaret E

2011-01-01

Encouraged by the potential health benefits of higher dietary intake of substances with beneficial properties, the use of supplements containing these compounds has increased steadily over recent years. The effects of several of these, many of which are antioxidants, have been supported by data obtained in vitro, in animal models, and often by human studies as well. However, as carefully controlled human supplementation trials have been conducted, questions about the efficacy and safety of these supplements have emerged. In this Educational Paper, three different supplements were selected for consideration of the benefits and risks currently associated with their intake. The selected supplements include β-carotene, selenium, and genistein. The use of each is discussed in the context of preclinical and clinical data that provide evidence for both their use in reducing disease incidence and the possible liabilities that accompany their enhanced consumption. Variables that may influence their impact, such as lifestyle habits, baseline nutritional levels, and genetic makeup are considered and the application of these issues to broader classes of supplements is discussed. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Analysis of Salmon and Steelhead Supplementation, 1990 Final Report.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miller, William H.; Coley, Travis C.; Burge, Howard L.

Supplementation or planting salmon and steelhead into various locations in the Columbia River drainage has occurred for over 100 years. All life stages, from eggs to adults, have been used by fishery managers in attempts to establish, rebuild, or maintain anadromous runs. This report summarizes and evaluates results of past and current supplementation of salmon and steelhead. Conclusions and recommendations are made concerning supplementation. Hatchery rearing conditions and stocking methods can affect post released survival of hatchery fish. Stress was considered by many biologists to be a key factor in survival of stocked anadromous fish. Smolts were the most commonmore » life stage released and size of smolts correlated positively with survival. Success of hatchery stockings of eggs and presmolts was found to be better if they are put into productive, underseeded habitats. Stocking time, method, species stocked, and environmental conditions of the receiving waters, including other fish species present, are factors to consider in supplementation programs. The unpublished supplementation literature was reviewed primarily by the authors of this report. Direct contact was made in person or by telephone and data compiled on a computer database. Areas covered included Oregon, Washington, Idaho, Alaska, California, British Columbia, and the New England states working with Atlantic salmon. Over 300 projects were reviewed and entered into a computer database. The database information is contained in Appendix A of this report. 6 refs., 9 figs., 21 tabs.« less

Use and perception of herbal and dietary supplements in the Hutterites of South Dakota.

PubMed

Peters, Stacy; Shiyanbola, Olayinka

2013-12-01

South Dakota is home to 6,000 Hutterites, the largest population of Hutterites in the United States. Observation of frequent supplement use by this population prompted the current survey based study. Use of supplements is on the rise with around 53 percent of Americans reporting at least one herbal and dietary supplement (HDS). Use and perception of HDS has not previously been evaluated in the Hutterite population. Participants were 18 years of age and older and had to be present at the time of survey administration. Surveys were administered before and after an educational presentation at five colonies to volunteer participants. Survey data was analyzed using descriptive analysis and chi-square tests. One-hundred and six surveys were completed with 81.1 percent being female. Approximately 78 percent reported using at least one type of HDS, with an average of 2.7 (SD = 1.4) supplements per person. Women were more likely to report supplement use than men. Hutterites reported they felt HDS were safer than prescription medications. Education was effective on some aspects such as telling their doctor if they are taking HDS. Some study limitations included small sample size, possible lack of survey understanding, and the limited number of male participants. The frequency of HDS use in South Dakota Hutterites appears to be very high. Baseline knowledge on the safety and regulation of HDS reveals that education of this population is needed. Further investigation of HDS use in Hutterites is warranted.

Early supplemented low-protein diet restriction for chronic kidney disease patients in Taiwan - A cost-effectiveness analysis.

PubMed

You, Joyce H S; Ming, Wai-Kit; Lin, Wei-An; Tarn, Yen-Huei

2015-10-01

Low-protein diet (LPD) together with supplementation with ketoanalogs (KA) is associated with slower decline of estimated glomerular filtration rate (eGFR) in chronic kidney disease (CKD). We compared potential clinical and economic outcomes of KA supplement initiation at eGFR 15 - 29 mL/min/1.73 m2 vs. eGFR < 15 mL/min/1.73 m2 in CKD patients on LPD from the healthcare payer's perspective. Markov model was designed to simulate outcomes of adult patients with eGFR 15 - 29 mL/min/1.73 m2 on two strategies LPD with KA supplementation; watchfulwaiting on LPD alone and KA initiation when eGFR declined to < 15 mL/min/1.73 m2. Medical cost and quality-adjusted life-years (QALYs) were calculated over 10 years. Results The early-initiation group gained higher QALYs (3.926 QALYs vs. 3.787 QALYs) with lower cost (USD 564,637 vs. USD 914,236) (USD 1 = NTD 30) when compared with the watchful-waiting group in base-case analysis. Sensitivity analysis indicated that early KA initiation at eGFR at 17 - 29 mL/min/1.73 m2 would be the preferred cost-effective option, if relative reduction of eGFR decline associated with LPD plus KA was > 4%. 10,000 Monte Carlo simulations showed the early-initiation group to be less costly with higher QALYs gained than the watchful-waiting group by USD 343,665 (95% CI 342,139 - 345,191) and 0.160 QALYs (95% CI 0.140 - 0.180), respectively. Early KA supplementation with LPD in CKD patients appeared to be cost-saving and gained higher QALYs in Taiwan. Acceptance of early supplemented LPD as cost-effective depended upon the reduction of eGFR decline associated with KA plus LPD and eGFR level to initiate KA supplementation.

Effect of vitamin E supplementation on serum C-reactive protein level: a meta-analysis of randomized controlled trials.

PubMed

Saboori, S; Shab-Bidar, S; Speakman, J R; Yousefi Rad, E; Djafarian, K

2015-08-01

C-reactive protein (CRP), a marker of chronic inflammation, has a major role in the etiology of chronic disease. Vitamin E may have anti-inflammatory effects. However, there is no consensus on the effects of vitamin E supplementation on CRP levels in clinical trials. The aim of this study was to systematically review randomized controlled trials (RCTs) that report on the effects of vitamin E supplementation (α- and γ-tocopherols) on CRP levels. A systematic search of RCTs was conducted on Medline and EMBASE through PubMed, Scopus, Ovid and Science Direct, and completed by a manual review of the literature up to May 2014. Pooled effects were estimated by using random-effects models and heterogeneity was assessed by Cochran's Q and I(2) tests. Subgroup analyses and meta-regression analyses were also performed according to intervention duration, dose of supplementation and baseline level of CRP. Of 4734 potentially relevant studies, only 12 trials met the inclusion criteria with 246 participants in the intervention arms and 249 participants in control arms. Pooled analysis showed a significant reduction in CRP levels of 0.62 mg/l (95% confidence interval = -0.92, -0.31; P < 0.001) in vitamin E-treated individuals, with the evidence of heterogeneity across studies. This significant effect was maintained in all subgroups, although the univariate meta-regression analysis showed that the vitamin E supplementation dose, baseline level of CRP and duration of intervention were not the sources of the observed heterogeneity. The results of this meta-analysis suggest that supplementation with vitamin E in the form of either α-tocopherol or γ-tocopherol would reduce serum CRP levels.

Applying importance-performance analysis to patient safety culture.

PubMed

Lee, Yii-Ching; Wu, Hsin-Hung; Hsieh, Wan-Lin; Weng, Shao-Jen; Hsieh, Liang-Po; Huang, Chih-Hsuan

2015-01-01

The Sexton et al.'s (2006) safety attitudes questionnaire (SAQ) has been widely used to assess staff's attitudes towards patient safety in healthcare organizations. However, to date there have been few studies that discuss the perceptions of patient safety both from hospital staff and upper management. The purpose of this paper is to improve and to develop better strategies regarding patient safety in healthcare organizations. The Chinese version of SAQ based on the Taiwan Joint Commission on Hospital Accreditation is used to evaluate the perceptions of hospital staff. The current study then lies in applying importance-performance analysis technique to identify the major strengths and weaknesses of the safety culture. The results show that teamwork climate, safety climate, job satisfaction, stress recognition and working conditions are major strengths and should be maintained in order to provide a better patient safety culture. On the contrary, perceptions of management and hospital handoffs and transitions are important weaknesses and should be improved immediately. Research limitations/implications - The research is restricted in generalizability. The assessment of hospital staff in patient safety culture is physicians and registered nurses. It would be interesting to further evaluate other staff's (e.g. technicians, pharmacists and others) opinions regarding patient safety culture in the hospital. Few studies have clearly evaluated the perceptions of healthcare organization management regarding patient safety culture. Healthcare managers enable to take more effective actions to improve the level of patient safety by investigating key characteristics (either strengths or weaknesses) that healthcare organizations should focus on.

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single propeller elements (for example...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

14 CFR 35.15 - Safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... combined with sound design and test philosophies. (b) If significant doubt exists as to the effects of... STANDARDS: PROPELLERS Design and Construction § 35.15 Safety analysis. (a)(1) The applicant must analyze the... to be verified by test. (c) The primary failures of certain single elements (for example, blades...

NIH and USDA Funding of Dietary Supplement Research, 1999–20071

PubMed Central

Regan, Karen S.; Wambogo, Edwina A.; Haggans, Carol J.

2011-01-01

Over one-half of U.S. adults use dietary supplements, so federally supported research into the safety and effectiveness of these compounds is important for the health of many Americans. Data collected in the Computer Access to Research on Dietary Supplements database, which compiles federally sponsored dietary supplement-related research, are useful to scientists in determining the type of dietary supplement research that federal agencies are currently funding and where research gaps exist. This article describes the dietary supplement-related research funded by the NIH and the USDA. Between fiscal years 1999 and 2007, the number of research projects and funding for dietary supplement research more than doubled. During that period, NIH funded 6748 dietary supplement-related projects at a cost of $1.9 billion and the USDA funded 2258 projects at a cost of $347 million. The top funded dietary supplement ingredient categories were vitamins and minerals, botanicals, phytochemicals, and fatty acids. Cancer was by far the most frequent health outcome in dietary supplement research funding, nearly double the next closest health outcome category. Other health outcomes with the greatest funding were cellular and molecular mechanisms, cardiovascular health, women’s reproductive health, and immune function. The greatest number of dietary supplement research projects are funded by the NIH National Cancer Institute, the NIH National Center for Complementary and Alternative Medicine, the NIH Office of Dietary Supplements, and the USDA Agricultural Research Service. PMID:21106929

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.

Safety analysis report for packaging (onsite) steel drum

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCormick, W.A.

This Safety Analysis Report for Packaging (SARP) provides the analyses and evaluations necessary to demonstrate that the steel drum packaging system meets the transportation safety requirements of HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments, for an onsite packaging containing Type B quantities of solid and liquid radioactive materials. The basic component of the steel drum packaging system is the 208 L (55-gal) steel drum.

Calcium supplementation improves clinical outcome in intensive care unit patients: a propensity score matched analysis of a large clinical database MIMIC-II.

PubMed

Zhang, Zhongheng; Chen, Kun; Ni, Hongying

2015-01-01

Observational studies have linked hypocalcemia with adverse clinical outcome in critically ill patients. However, calcium supplementation has never been formally investigated for its beneficial effect in critically ill patients. To investigate whether calcium supplementation can improve 28-day survival in adult critically ill patients. Secondary analysis of a large clinical database consisting over 30,000 critical ill patients was performed. Multivariable analysis was performed to examine the independent association of calcium supplementation and 28-day morality. Furthermore, propensity score matching technique was employed to investigate the role of calcium supplementation in improving survival. none. Primary outcome was the 28-day mortality. 90-day mortality was used as secondary outcome. A total of 32,551 adult patients, including 28,062 survivors and 4489 non-survivors (28-day mortality rate: 13.8 %) were included. Calcium supplementation was independently associated with improved 28-day mortality after adjusting for confounding variables (hazard ratio: 0.51; 95 % CI 0.47-0.56). Propensity score matching was performed and the after-matching cohort showed well balanced covariates. The results showed that calcium supplementation was associated with improved 28- and 90-day mortality (p < 0.05 for both Log-rank test). In adult critically ill patients, calcium supplementation during their ICU stay improved 28-day survival. This finding supports the use of calcium supplementation in critically ill patients.

14 CFR 26.47 - Holders of and applicants for a supplemental type certificate-Alterations and repairs to...

Code of Federal Regulations, 2010 CFR

2010-01-01

... supplemental type certificate must— (1) Review the repair data, and identify each repair that affects any... supplemental type certificate-Alterations and repairs to alterations. 26.47 Section 26.47 Aeronautics and Space... IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance Data for Repairs and...

14 CFR 26.47 - Holders of and applicants for a supplemental type certificate-Alterations and repairs to...

Code of Federal Regulations, 2012 CFR

2012-01-01

... supplemental type certificate must— (1) Review the repair data, and identify each repair that affects any... supplemental type certificate-Alterations and repairs to alterations. 26.47 Section 26.47 Aeronautics and Space... IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance Data for Repairs and...

14 CFR 26.47 - Holders of and applicants for a supplemental type certificate-Alterations and repairs to...

Code of Federal Regulations, 2014 CFR

2014-01-01

... supplemental type certificate must— (1) Review the repair data, and identify each repair that affects any... supplemental type certificate-Alterations and repairs to alterations. 26.47 Section 26.47 Aeronautics and Space... IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance Data for Repairs and...

14 CFR 26.47 - Holders of and applicants for a supplemental type certificate-Alterations and repairs to...

Code of Federal Regulations, 2013 CFR

2013-01-01

... supplemental type certificate must— (1) Review the repair data, and identify each repair that affects any... supplemental type certificate-Alterations and repairs to alterations. 26.47 Section 26.47 Aeronautics and Space... IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance Data for Repairs and...

Analysis of dynamical response of air blast loaded safety device

NASA Astrophysics Data System (ADS)

Tropkin, S. N.; Tlyasheva, R. R.; Bayazitov, M. I.; Kuzeev, I. R.

2018-03-01

Equipment of many oil and gas processing plants in the Russian Federation is considerably worn-out. This causes the decrease of reliability and durability of equipment and rises the accident rate. An air explosion is the one of the most dangerous cases for plants in oil and gas industry, usually caused by uncontrolled emission and inflammation of oil products. Air explosion can lead to significant danger for life and health of plant staff, so it necessitates safety device usage. A new type of a safety device is designed. Numerical simulation is necessary to analyse design parameters and performance of the safety device, subjected to air blast loading. Coupled fluid-structure interaction analysis is performed to determine strength of the protective device and its performance. The coupled Euler-Lagrange method, allowable in Abaqus by SIMULIA, is selected as the most appropriate analysis tool to study blast wave interaction with the safety device. Absorption factors of blast wave are evaluated for the safety device. This factors allow one to assess efficiency of the safety device, and its main structural component – dampener. Usage of CEL allowed one to model fast and accurately the dampener behaviour, and to develop the parametric model to determine safety device sizes.

Liver Injury from Herbal and Dietary Supplements

PubMed Central

Navarro, Victor; Khan, Ikhlas; Björnsson, Einar; Seeff, Leonard B.; Serrano, Jose; Hoofnagle, Jay H.

2017-01-01

Herbal and dietary supplements (HDS) are used increasingly both in the United States and worldwide and HDS induced liver injury in the U.S. has increased proportionally. Current challenges in the diagnosis and management of HDS-induced liver injury were the focus of a 2-day research symposium sponsored by the American Association for the Study of Liver Disease and the National Institutes of Health. HDS-induced liver injury now accounts for 20% of cases of hepatotoxicity in the United States based on research data. The major implicated agents include anabolic steroids, green tea extract, and multi-ingredient nutritional supplements (MINS). Anabolic steroids marketed as bodybuilding supplements typically induce a prolonged cholestatic, but ultimately self-limiting liver injury that has a distinctive serum biochemical as well as histological phenotype. Green tea extract and many other products, in contrast, tend to cause an acute-hepatitis like injury. Currently, however, the majority of cases of HDS-associated liver injury are due to MINS, and the component responsible for the toxicity is usually unknown or can only be suspected. HDS-induced liver injury presents many clinical and research challenges, in diagnosis, identification of the responsible constituents, treatment and prevention. Also important are improvements in regulatory oversight of non-prescription products to guarantee their constituents and insure purity and safety. The confident identification of injurious ingredients within HDS will require strategic alignments among clinicians, chemists, and toxicologists. The ultimate goal should be to prohibit or more closely regulate potentially injurious ingredients and thus promote public safety. PMID:27677775

Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

PubMed

Sztam, Kevin A; Ndirangu, Murugi; Sheriff, Muhsin; Arpadi, Stephen M; Hawken, Mark; Rashid, Juma; Deckelbaum, Richard J; El Sadr, Wafaa M

2013-01-01

Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

Effects of blueberry supplementation on blood pressure: a systematic review and meta-analysis of randomized clinical trials.

PubMed

Zhu, Y; Sun, J; Lu, W; Wang, X; Wang, X; Han, Z; Qiu, C

2017-03-01

Blueberries belong to the genus Vaccinium of the family Ericaceae. A series of epidemiological studies have demonstrated that blueberry polyphenols, particularly blueberry anthocyanins provide significant beneficial effects for humans. However, the findings of clinical studies have been equivocal. Therefore, we sought to assess the potential anti-hypertensive effects of blueberry supplementation through a meta-analysis of available randomized controlled trials (RCTs). A comprehensive literature search of PubMed, The Cochrane Library, AMED (Allied and Complementary Medicine Database), Embase, Web of Science, Wanfang Database, and China National Knowledge Infrastructure were performed to identify potential studies published before June 2015. The standardized mean difference and 95% confidence interval (CI) were used as summary statistics. Net changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) between the blueberry and placebo groups were calculated by subtracting the values at the end of follow-up from those at baseline. Meta-regression was used to identify potential moderators of effect size. Six RCT studies with 204 participants were included in our meta-analysis. There was no significant effect of blueberry supplementation on changes in blood pressure (BP) relative to baseline, and there was a mean difference of -0.28 (95% CI: -1.11 to 0.56, I 2 =87%) and -0.5 (95% CI: -1.24 to 0.24, I 2 =84%) mmHg for SBP and DBP, respectively. In summary, the results from this meta-analysis do not favor any clinical efficacy of blueberry supplementation in improving BP. Further well-designed larger RCTs are required to verify the association between blueberry supplementation and BP.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

PubMed

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

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.

Adverse and Advantageous Selection in the Medicare Supplemental Market: A Bayesian Analysis of Prescription drug Expenditure.

PubMed

Li, Qian; Trivedi, Pravin K

2016-02-01

This paper develops an extended specification of the two-part model, which controls for unobservable self-selection and heterogeneity of health insurance, and analyzes the impact of Medicare supplemental plans on the prescription drug expenditure of the elderly, using a linked data set based on the Medicare Current Beneficiary Survey data for 2003-2004. The econometric analysis is conducted using a Bayesian econometric framework. We estimate the treatment effects for different counterfactuals and find significant evidence of endogeneity in plan choice and the presence of both adverse and advantageous selections in the supplemental insurance market. The average incentive effect is estimated to be $757 (2004 value) or 41% increase per person per year for the elderly enrolled in supplemental plans with drug coverage against the Medicare fee-for-service counterfactual and is $350 or 21% against the supplemental plans without drug coverage counterfactual. The incentive effect varies by different sources of drug coverage: highest for employer-sponsored insurance plans, followed by Medigap and managed medicare plans. Copyright © 2014 John Wiley & Sons, Ltd.

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-01-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sharirli, M.; Rand, J.L.; Sasser, M.K.

1992-12-01

The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

Effects of calcium plus vitamin D supplementation on blood pressure: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Wu, L; Sun, D

2017-09-01

The effect of calcium or vitamin D supplement on blood pressure (BP) has been explored in previous meta-analyses, but the results are conflicting. The combined efficacy of calcium and vitamin D on BP has not been systematically assessed. Thus, we conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effect of calcium plus vitamin D (CaD) supplementation on changes of systolic blood pressure (SBP) and diastolic blood pressure among male and female participants (with and without diagnosed hypertension) aged 18 years or older. The PubMed, the Embase and the Cochrane Central Register of controlled trials were searched. A random effects model was used to calculate the pooled weighted mean differences (WMDs) with 95% confidence intervals (CIs) for the continuous outcome data. Cochrane Collaboration tool was used to assess the study quality of each trial. We further performed subgroup analysis and meta-regression by ethnicity, gender, age, health status, supplement dose, co-interventions, supplement duration and quality assessment. Eight RCTs involving 36 806 participants were assessed. The follow-up time ranged from 15 weeks to a maximum of 7 years. No meaningful effect on daytime office BP was detected in the present study, with evidence of significant heterogeneity. Subgroup analysis by gender indicated some evidence of elevated SBP in male participants, and the WMD (95% CI) was 1.49 mm Hg (1.03, 1.95). Further high-quality research is still warranted to confirm the magnitude of the effect of CaD supplementation on the changes of BP among participants with different ethnicity, gender, health status and CaD supplements.

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements.

PubMed

Sprouse, Alyssa A; van Breemen, Richard B

2016-02-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug-botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John's wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug-botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug-botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

Vitamin D Supplementation for Depressive Symptoms: A Systematic Review and Meta-analysis of Randomized Controlled Trials

PubMed Central

Shaffer, Jonathan A.; Edmondson, Donald; Wasson, Lauren Taggart; Falzon, Louise; Homma, Kirsten; Ezeokoli, Nchedcochukwu; Li, Peter; Davidson, Karina W.

2014-01-01

Objective To review the effects of vitamin D supplementation on depression or depressive symptoms in randomized controlled trials. Although low vitamin D levels have been observationally associated with depression and depressive symptoms, the effect of vitamin D supplementation as an antidepressant remains uncertain. METHODS MEDLINE, CINAHL, Allied and Complimentary Medicine Database, PsycINFO, Scopus, and The Cochrane Library, and references of included reports (through May 2013) were searched. Two independent reviewers identified randomized trials that compared the effect of vitamin D supplementation on depression or depressive symptoms to a control condition. Two additional reviewers independently reviewed and extracted relevant data; disagreements were reconciled by consensus. The Cochrane Risk of Bias Tool was used to assess study quality. Seven trials (3191 participants) were included. RESULTS Vitamin D supplementation had no overall effect on depressive symptoms (standardized mean difference [SMD], −0.14; 95% CI, −0.33 to 0.05; P = 0.16), although considerable heterogeneity was observed. Subgroup analysis showed that vitamin D supplementation for participants with clinically significant depressive symptoms or depressive disorder had a moderate, statistically significant effect (2 studies: SMD, −0.60; 95% CI, −1.19 to −0.01; P = 0.046), but a small, nonsignificant effect for those without clinically significant depression (5 studies: SMD, −0.04; CI, −0.20 to 0.12; P = 0.61). Most trials had unclear or high risk of bias. Studies varied in the amount, frequency, duration, and mode of delivery of vitamin D supplementation. Conclusion Vitamin D supplementation may be effective for reducing depressive symptoms in patients with clinically significant depression; however, further high quality research is needed. PMID:24632894

FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.

PubMed

Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data

Calcium and Vitamin D Supplementation for Prevention of Preeclampsia: A Systematic Review and Network Meta-Analysis

PubMed Central

Khaing, Win; Vallibhakara, Sakda Arj-Ong; Tantrakul, Visasiri; Vallibhakara, Orawin; Rattanasiri, Sasivimol; McEvoy, Mark; Attia, John; Thakkinstian, Ammarin

2017-01-01

Vitamin D supplementation effects with or without calcium in pregnancy for reducing risk of preeclampsia and gestational or pregnancy induced hypertension are controversial. Literature was systematically searched in Medline, Scopus and Cochrane databases from inception to July 2017. Only randomized controlled trials (RCTs) in English were selected if they had any pair of interventions (calcium, vitamin D, both, or placebo). Systematic review with two-step network-meta-analysis was used to indirectly estimate supplementary effects. Twenty-seven RCTs with 28,000 women were eligible. A direct meta-analysis suggested that calcium, vitamin D, and calcium plus vitamin D could lower risk of preeclampsia when compared to placebo with the pooled risk ratios (RRs) of 0.54 (0.41, 0.70), 0.47 (0.24, 0.89) and 0.50 (0.32, 0.78), respectively. Results of network meta-analysis were similar with the corresponding RRs of 0.49 (0.35, 0.69), 0.43 (0.17, 1.11), and 0.57 (0.30, 1.10), respectively. None of the controls were significant. Efficacy of supplementation, which was ranked by surface under cumulative ranking probabilities, were: vitamin D (47.4%), calcium (31.6%) and calcium plus vitamin D (19.6%), respectively. Calcium supplementation may be used for prevention for preeclampsia. Vitamin D might also worked well but further large scale RCTs are warranted to confirm our findings. PMID:29057843

Calcium and Vitamin D Supplementation for Prevention of Preeclampsia: A Systematic Review and Network Meta-Analysis.

PubMed

Khaing, Win; Vallibhakara, Sakda Arj-Ong; Tantrakul, Visasiri; Vallibhakara, Orawin; Rattanasiri, Sasivimol; McEvoy, Mark; Attia, John; Thakkinstian, Ammarin

2017-10-18

Vitamin D supplementation effects with or without calcium in pregnancy for reducing risk of preeclampsia and gestational or pregnancy induced hypertension are controversial. Literature was systematically searched in Medline, Scopus and Cochrane databases from inception to July 2017. Only randomized controlled trials (RCTs) in English were selected if they had any pair of interventions (calcium, vitamin D, both, or placebo). Systematic review with two-step network-meta-analysis was used to indirectly estimate supplementary effects. Twenty-seven RCTs with 28,000 women were eligible. A direct meta-analysis suggested that calcium, vitamin D, and calcium plus vitamin D could lower risk of preeclampsia when compared to placebo with the pooled risk ratios (RRs) of 0.54 (0.41, 0.70), 0.47 (0.24, 0.89) and 0.50 (0.32, 0.78), respectively. Results of network meta-analysis were similar with the corresponding RRs of 0.49 (0.35, 0.69), 0.43 (0.17, 1.11), and 0.57 (0.30, 1.10), respectively. None of the controls were significant. Efficacy of supplementation, which was ranked by surface under cumulative ranking probabilities, were: vitamin D (47.4%), calcium (31.6%) and calcium plus vitamin D (19.6%), respectively. Calcium supplementation may be used for prevention for preeclampsia. Vitamin D might also worked well but further large scale RCTs are warranted to confirm our findings.

Review of the safety and efficacy of vitamin A supplementation in the treatment of children with severe acute malnutrition.

PubMed

Iannotti, Lora L; Trehan, Indi; Manary, Mark J

2013-09-12

World Health Organization (WHO) guidelines recommend for children with severe acute malnutrition (SAM), high-dose vitamin A (VA) supplements be given on day 1 of admission, and on days 2 and 14 in the case of clinical signs of vitamin A deficiency (VAD). Daily low-dose VA follows, delivered in a premix added to F-75 and F-100. This study aimed to systematically review the evidence for safety and effectiveness of high-dose VA supplementation (VAS) in treatment of children with SAM. A comprehensive literature review was undertaken for all relevant randomized controlled trials (RCT) and observational studies from 1950 to 2012. Studies identified for full review were evaluated using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology using a set of pre-defined criteria: indirectness; inconsistency; imprecision; and study limitations. A quality rating of high, moderate, or low was then assigned to each study, and only those attaining moderate to high were considered in making recommendations. Of the 2072 abstracts screened, 38 met criteria for full review, and 20 were rated moderate to high quality. Only one study replicated the WHO VA protocol in children with SAM. Indirectness was a critical limitation, as studies were not exclusive to children with SAM. There was inconsistency across trials for definitions of malnutrition, morbidities, and ages studied; and imprecision arising from sub-group analyses and small sample sizes. Evidence showed improved outcomes associated with low-dose compared to high-dose VAS, except in cases presenting with signs of VAD, measles, and severe diarrhea or shigellosis. Adverse outcomes related to respiratory infection, diarrhea, and growth were associated with high-dose VAS in children who were predominantly adequately nourished. No adverse effects of the high dose were found in children with SAM in the trial that replicated the WHO VA guideline. This is the first systematic review of the safety and

Simultaneous analysis of 17 diuretics in dietary supplements by HPLC and LC-MS/MS.

PubMed

Woo, H; Kim, J W; Han, K M; Lee, J H; Hwang, I S; Lee, J H; Kim, J; Kweon, S J; Cho, S; Chae, K R; Han, S Y; Kim, J

2013-01-01

In order to test health foods for illegally added diuretics for weight loss, we developed simple, rapid, selective, and sensitive methods using HPLC and LC-MS/MS for the simultaneous analysis of 17 diuretics in dietary supplements. HPLC conditions were set with a Capcell-pak C18, using a mobile phase consisting of gradient conditions, UV detection at 254 nm and validated for linearity (r(2)> 0.999), precision (CV ≤ 3%), recoveries (90.4-102.8%) and reproducibility. Identification and quantification of 17 diuretics were accomplished by ion-spray LC-MS/MS using multiple reaction monitoring (MRM). The chromatographic separation was carried out under the reversed-phase mechanism on an HSS-T3 column. The LC-MS/MS method was validated for linearity (r(2)> 0.99) and precision (CV < 13%). Sixteen dietary supplements were tested with the developed methods. Diuretics were not detected in all samples. Extraction recovery was also investigated and the extraction recoveries in different formulations were from 88% to 110% and from 81% to 116% using HPLC and LC-MS/MS, respectively. There was no significant difference in recoveries in the type of dietary supplements. Based on this result, the developed methods to monitor illegal drug adulterations in dietary supplements using HPLC and LC-MS/MS are simple, fast and reliable. Therefore, it is applicable to routine drug-adulteration screening.

Oral potassium supplementation for management of essential hypertension: A meta-analysis of randomized controlled trials

PubMed Central

Zeraati, Fatemeh; Soltanian, Ali Reza; Sheikh, Vida; Hooshmand, Elham; Maleki, Akram

2017-01-01

Importance Increased dietary potassium intake is thought to be associated with low blood pressure (BP). Whether potassium supplementation may be used as an antihypertensive agent is a question that should be answered. Objective To assess the effect of oral potassium supplementation on blood pressure in patients with primary hypertension. Search methods We searched Medline, Web of Science, Scopus, Cochrane Central Register of Controlled Trials until October 2016. We also screened reference lists of articles and previous reviews. We applied no language restrictions. Selection criteria We included randomized placebo-controlled clinical trials addressing the effect of potassium supplementation on primary hypertension for a minimum of 4 weeks. Data collection and analysis We extracted data on systolic and diastolic BP (SBP and DBP) at the final follow-up. We explored the heterogeneity across studies using Cochran's test and I2 statistic and assessed the probability of publication bias using Begg's and Egger's tests. We reported the mean difference (MD) of SBP and DBP in a random-effects model. Results We found a total of 9059 articles and included 23 trials with 1213 participants. Compared to placebo, potassium supplementation resulted in modest but significant reductions in both SBP (MD -4.25 mmHg; 95% CI: -5.96 to -2.53; I2 = 41%) and DBP (MD -2.53 mmHg; 95% CI: -4.05 to -1.02; I2 = 65%). According to the change-score analysis, based on 8 out of 23 trials, compared to baseline, the mean changes in SBP (MD -8.89 mmHg; 95% CI: -13.67 to -4.11) and DBP (MD -6.42 mmHg; 95% CI: -10.99 to -1.84) was significantly higher in the intervention group than the control group. Conclusions Our findings indicated that potassium supplementation is a safe medication with no important adverse effects that has a modest but significant impact BP and may be recommended as an adjuvant antihypertensive agent for patients with essential hypertension. PMID:28419159

Effects of alpha-lipoic acid supplementation on C-reactive protein level: A systematic review and meta-analysis of randomized controlled clinical trials.

PubMed

Saboori, S; Falahi, E; Eslampour, E; Zeinali Khosroshahi, M; Yousefi Rad, E

2018-04-17

The aim of this meta-analysis was to assess effects of alpha-lipoic acid supplementation on C-reactive protein (CRP) levels in clinical trial studies. A systematic search was carried out on clinical trial studies published in PubMed, ISI Web of Science, Cochrane Library and Scopus databases completed by manual search on reference list of eligible studies accomplished by November 4, 2017. Of a total number of 508 studies found in the first step of literature search, only 11 were included with 264 participants in supplementation groups and 287 in control groups. Estimated pooled random effects size analysis showed a significant reducing effect of alpha-lipoic acid supplementation on CRP level (-0.72 mg/l, 95% CI; -1.4, -0.04; P = 0.03) with a significant heterogeneity between the selected studies. Sub-group analysis showed that alpha-lipoic acid supplementation could significantly reduce serum CRP level when the baseline CRP level was greater than 3 mg/l (-1.02 mg/l, 95% CI: -1.3, -0.73) and when trial duration was >8 weeks (-0.99 mg/l, 95% CI: -1.29, -0.70). Results of subgroup analysis also showed that alpha lipoic acid supplementation could decrease CRP level only in non-diabetic patients (-1.02 mg/l, 95% CI: -1.31, -0.74). Results of the current meta-analysis study showed that alpha-lipoic acid supplementation could significantly decrease CRP level in patients with elevated levels of this inflammatory marker. Copyright © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Safety on the Job. Some Guidelines for Working Safely. Instructor's Edition.

ERIC Educational Resources Information Center

Oklahoma State Dept. of Vocational and Technical Education, Stillwater. Curriculum and Instructional Materials Center.

This teacher's guide was developed to help teachers (especially in Oklahoma) promote safe practices on the job. As a supplement to existing programs in the requirements for job safety, this book can also promote same basic safety attitudes and help support basic safety concepts, with an emphasis on accident prevention. The guide contains eight…

Effect of daily iron supplementation on health in children aged 4-23 months: a systematic review and meta-analysis of randomised controlled trials.

PubMed

Pasricha, Sant-Rayn; Hayes, Emily; Kalumba, Kongolo; Biggs, Beverley-Ann

2013-08-01

About 47% of preschool children worldwide are anaemic. Daily oral iron supplementation is a commonly recommended intervention for treatment and prevention of anaemia, but the efficacy and safety of iron supplementation programmes is debated. Thus, we systematically reviewed the evidence for benefit and safety of daily iron supplementation in children aged 4-23 months. We searched Scopus and Medline, from inception to Feb 5, 2013, WHO databases, theses repositories, grey literature, and references. Randomised controlled trials that assigned children 4-23 months of age to daily oral iron supplementation versus control were eligible. We calculated mean difference (MD) or standard MD (SMD) for continuous variables, risk ratios for dichotomous data, and rate ratios for rates. We quantified heterogeneity with the I(2) test and synthesised all data with a random-effects model. This review is registered with the International Prospective Register of Systematic Reviews, number CRD42011001208. Of 9533 citations identified by the search strategy, 49 articles from 35 studies were eligible; these trials included 42,306 children. Only nine studies were judged to be at low risk of bias. In children receiving iron supplements, the risk ratio for anaemia was 0·61 (95% CI 0·50-0·74; 17 studies, n=4825), for iron deficiency was 0·30 (0·15-0·60; nine studies, n=2464), and for iron deficiency anaemia was 0·14 (0·10-0·22; six studies, n=2145). We identified no evidence of difference in mental (MD 1·65, 95% CI -0·63 to 3·94; six studies, n=1093) or psychomotor development (1·05, -1·36 to 3·46; six studies, n=1086). We noted no significant differences in final length or length-for-age, or final weight or weight-for-age. Children randomised to iron had slightly lesser length (SMD -0·83, -1·53 to -0·12; eight studies, n=868) and weight gain (-1·12, -1·19 to -0·33) over the course of the studies. Vomiting (risk ratio 1·38, 95% CI 1·10-1·73) and fever (1·16, 1·02-1�

The role of enzyme supplementation in digestive disorders.

PubMed

Roxas, Mario

2008-12-01

This article reviews various forms of enzyme supplementation used clinically in digestive and absorption disorders. Enzyme supplementation plays an integral role in the management of various digestive disorders, particularly with regard to exocrine pancreatic insufficiency. However, application of enzymes may also be beneficial for other conditions associated with poor digestion including lactose intolerance. Historically, porcine and bovine pancreatic enzymes have been the preferred form of supplementation for exocrine pancreatic insufficiency. Use of microbe-derived lipase has shown promise with studies indicating benefit similar to pancreatic enzymes, but at a lower dosage concentration and with a broader pH range. Safety and efficacy of enzymes derived from microbial species in the treatment of conditions such as malabsorption and lactose intolerance is promising. Plant-based enzymes, such as bromelain from pineapple, serve as effective digestive aids in the breakdown of proteins. Synergistic effects have been observed using a combination of animal-based enzymes and microbe-derived enzymes or bromelain.

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.

The effect of challenge and hindrance stressors on safety behavior and safety outcomes: a meta-analysis.

PubMed

Clarke, Sharon

2012-10-01

The significance of occupational stressors as a risk factor in accidents has long been recognized; however, the behavioral mechanisms underlying this relationship are currently not well-understood. Meta-analysis was utilized to test the relationships between occupational stressors (challenge and hindrance), safety behaviors (compliance and participation), and safety outcomes (occupational injuries and near-misses). It was hypothesized that hindrance stressors would have negative effects on both safety compliance and safety participation, and subsequently, safety outcomes, whereas challenge stressors would have positive effects. The hypotheses relating to hindrance stressors were supported, suggesting that hindrance stressors lead to a significant reduction in both compliance with safety rules and participation in safety-related activities. Hindrance stressors were also associated with higher levels of occupational injuries and near-misses. The relationship between hindrance stressors and occupational injuries was fully mediated by safety behaviors. However, the hypotheses related to challenge stressors were not supported. Challenge stressors had a nonsignificant, near-zero association with compliance and occupational injuries, a small negative association with participation, and a small positive association with near-misses. The theoretical and practical implications of the meta-analytic findings are discussed, as well as avenues for further research.

Effect of B Vitamin (Folate, B6, and B12) Supplementation on Osteoporotic Fracture and Bone Turnover Markers: A Meta-Analysis

PubMed Central

Ruan, Jianwei; Gong, Xiaokang; Kong, Jinsong; Wang, Haibao; Zheng, Xin; Chen, Tao

2015-01-01

Background B vitamins (including folate, B6, and B12) supplementation can effectively and easily modify high plasma homocysteine (Hcy). However, the role of Hcy in the pathogenesis of osteoporotic fracture and bone turnover is still controversial. This meta-analysis aimed to assess the impact of B vitamin supplementation on occurrence of any osteoporotic fracture and bone turnover by pooling the results of previous studies. Material/Methods Relevant randomized controlled trials (RCTs) were searched in databases. Data integration and analysis were done by using Review Manager 5.3 (the Cochrane Collaboration). The risk ratio (RR) and corresponding 95% confidence intervals (CI) of fracture (intervention vs. control) were estimated. Changes in bone turnover indicators (continuous data), weighted mean difference (WMD), and corresponding 95% (CI) were pooled for estimation. Results Based on the results of 4 RCTs, this meta-analysis failed to identify a risk-reducing effect of daily supplementation of B vitamins on osteoporotic fracture in patients with vascular disease and with relatively normal plasma Hcy. In addition, we also did not find any positive effects of B vitamin supplementation on bone turnover. Conclusions B vitamin supplementation might not be effective in preventing fracture and improving bone turnover. However, the possible benefits in selective populations, such as populations with very high plasma Hcy and from regions without B vitamin fortification should be explored in the future. PMID:25805360

System analysis of vehicle active safety problem

NASA Astrophysics Data System (ADS)

Buznikov, S. E.

2018-02-01

The problem of the road transport safety affects the vital interests of the most of the population and is characterized by a global level of significance. The system analysis of problem of creation of competitive active vehicle safety systems is presented as an interrelated complex of tasks of multi-criterion optimization and dynamic stabilization of the state variables of a controlled object. Solving them requires generation of all possible variants of technical solutions within the software and hardware domains and synthesis of the control, which is close to optimum. For implementing the task of the system analysis the Zwicky “morphological box” method is used. Creation of comprehensive active safety systems involves solution of the problem of preventing typical collisions. For solving it, a structured set of collisions is introduced with its elements being generated also using the Zwicky “morphological box” method. The obstacle speed, the longitudinal acceleration of the controlled object and the unpredictable changes in its movement direction due to certain faults, the road surface condition and the control errors are taken as structure variables that characterize the conditions of collisions. The conditions for preventing typical collisions are presented as inequalities for physical variables that define the state vector of the object and its dynamic limits.

Chromium supplementation and polycystic ovary syndrome: A systematic review and meta-analysis.

PubMed

Fazelian, Siavash; Rouhani, Mohamad H; Bank, Sahar Saraf; Amani, Reza

2017-07-01

polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women. Some vitamins and mineral can play role in improvement of PCOS. Chromium (Cr) is an essential element in glucose and insulin homeostasis. However, findings are not consistent regarding PCOS improvement. Therefore, the purpose of this paper was to assess the effect of Cr supplementation in PCOS that have not yet fully been elucidated. We searched ISI Web of Science, MEDLINE (1966 to June 2016), Google Scholar databases and Proquest and identified eligible papers and extracted the following terms: total testosterone, DHEAS, insulin sensitivity, fasting glucose, fasting insulin, OGTT 1h glucose, OGTT 2h glucose (mg/dL), LH (mIU/mL), FSH, DHEAS, ferriman-Galwey score (FG score). We calculated overall effect size with random effects model, between-study heterogeneity with I square (I 2 ) statistic. Publication bias was assessed using Begg's test regression. Totally, 7 RCTs were selected. Results indicated that Cr supplementation had a beneficial effect on BMI with effect size: -2.37 (kg/m 2 ), 95% CI: -2.99, -1.76, p=0.001 and free testosterone concentration with effect size=-0.52 (pg/mL), 95% CI: -0.83, -0.23, p=0.001. Cr reduced fasting insulin in subgroup of studies with >10 participants with effect size: -0.86mIU/ml, 95% CI: -0.67, -0.17; p=0.001. Cr supplementation had no beneficial effects on reducing total testosterone, FG score, DHEA, FSH and LH. This systematic review and meta-analysis shows that using Cr picolinate supplementation has beneficial effects on decreasing BMI, fasting insulin and free testosterone in PCOS patients. Copyright © 2017 Elsevier GmbH. All rights reserved.

Ares I-X Range Safety Flight Envelope Analysis

NASA Technical Reports Server (NTRS)

Starr, Brett R.; Olds, Aaron D.; Craig, Anthony S.

2011-01-01

Ares I-X was the first test flight of NASA's Constellation Program's Ares I Crew Launch Vehicle designed to provide manned access to low Earth orbit. As a one-time test flight, the Air Force's 45th Space Wing required a series of Range Safety analysis data products to be developed for the specified launch date and mission trajectory prior to granting flight approval on the Eastern Range. The range safety data package is required to ensure that the public, launch area, and launch complex personnel and resources are provided with an acceptable level of safety and that all aspects of prelaunch and launch operations adhere to applicable public laws. The analysis data products, defined in the Air Force Space Command Manual 91-710, Volume 2, consisted of a nominal trajectory, three sigma trajectory envelopes, stage impact footprints, acoustic intensity contours, trajectory turn angles resulting from potential vehicle malfunctions (including flight software failures), characterization of potential debris, and debris impact footprints. These data products were developed under the auspices of the Constellation's Program Launch Constellation Range Safety Panel and its Range Safety Trajectory Working Group with the intent of beginning the framework for the operational vehicle data products and providing programmatic review and oversight. A multi-center NASA team in conjunction with the 45th Space Wing, collaborated within the Trajectory Working Group forum to define the data product development processes, performed the analyses necessary to generate the data products, and performed independent verification and validation of the data products. This paper outlines the Range Safety data requirements and provides an overview of the processes established to develop both the data products and the individual analyses used to develop the data products, and it summarizes the results of the analyses required for the Ares I-X launch.

Effect of Lycopene Supplementation on Oxidative Stress: An Exploratory Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Jinyao; Song, Yang

2013-01-01

Abstract Lycopene is a potentially useful compound for preventing and treating cardiovascular diseases and cancers. Studies on the effects of lycopene on oxidative stress offer insights into its mechanism of action and provide evidence-based rationale for its supplementation. In this analysis, randomized controlled trials of the effects of oral lycopene supplementation on any valid outcomes of oxidative stress were identified and pooled through a search of international journal databases and reference lists of relevant publications. Two reviewers extracted data from each of the identified studies. Only studies of sufficient quality were included. Twelve parallel trials and one crossover trial were included in the systematic review, and six trials provided data for quantitative meta-analysis. Our results indicate that lycopene supplementation significantly decreases the DNA tail length, as determined using comet assays, with a mean difference (MD) of −6.27 [95% confidence interval (CI) −10.74, −1.90] (P=.006) between the lycopene intervention groups and the control groups. Lycopene supplementation does not significantly prolong the lag time of low-density lipoprotein (MD 3.76 [95% CI −2.48, 10.01]; P=.24). Lycopene possibly alleviates oxidative stress; however, biomarker research for oxidative stress needs be more consistent with the outcomes in lycopene intervention trials for disease prevention. PMID:23631493

Athlete Information Sources About Dietary Supplements: A Review of Extant Research.

PubMed

Denham, Bryan E

2017-08-01

In the United States, the Dietary Supplement Health and Education Act of 1994 (DSHEA) classified dietary supplements as a subcategory of food, exempting manufacturers from providing premarket evidence of product safety and efficacy. Under DSHEA, agencies such as the U.S. Food and Drug Administration (FDA) cannot inspect supplements until after the products have entered the marketplace. Recognizing that both limited resources and DSHEA prevent the FDA from conducting broad-based inspections on a regular basis, disreputable manufacturers have spiked products with drugs such as anabolic steroids and amphetamines. With contaminated supplements now causing athletes to fail drug tests and, in some instances, threatening public health, it becomes important to examine sources of supplement information. This article reviews 53 studies that have addressed athlete information sources about dietary supplements. It finds that athletes, in general, rely heavily on coaches and trainers as well as friends and family for information. Relative to U.S. athletes, those competing internationally appear more likely to seek information from a physician or nutritionist. The article offers recommendations for individuals and organizations based on the most frequent information sources identified by athletes.

Chondroprotection using naturally occurring mineral supplementation formula in degenerative osteoarthritis of the knees.

PubMed

Bansal, Himanshu; Bansal, Anupama; Agrawal, Diwaker; Singh, Dhananjay; Deb, Kaushik

2014-01-01

To evaluate the therapeutic and safety efficacy of a naturally occurring mineral supplementation in the treatment of symptomatic knee osteoarthritis (OA). A prospective, single centre, study of 50 patients aged 50 years and above with painful and radiological Osteoarthritis of knees was carried out for one year. Patients received 40 drops of naturally occurring commercially available mineral supplement concentrate mineral drops purportedly derived from the Great Salt Lake in Utah. Efficacy was objectively confirmed by evaluating changes in the thickness of articular cartilage, joint space width, synovial fluid analysis and subjectively by changes in WOMAC scores and 6 Minute pain-free Walking Distance. The composite WOMAC scores were significantly improved by 17.2 points from a mean of 52 at baseline by year end. 18 (41%) patients showed improvement of more than 100 feet for the pain free distance covered during a 6 minute walk at one year follow-up. Ultrasonologicaly, at one year cartilage thickness improved by at least 0.01 mm in 9 (21%) patients. Though radiologicallynone of patient showed increase in joint space it was noticed that only 2(4.6%) patients had decline of joint space width of more than 0.5 mm. Average cell count reduced to 205/microlitre from a value of 520/microlitre at the start of study suggesting that the mineral supplement used had structural efficacy. Clinically relevant, statistically significant symptomatic and statistically insignificant structural improvement occurred over 1 year period in patients receiving the naturally occurring mineral supplement. The protection of the joint cartilages from progressive degeneration during osteoarthritis by these supplements indicates towards a chondrocyte regenerative potential of this supplement. Such regeneration may occur through activation of tissue specific adult chondrocyte precursors or stem cells.

Vitamin D supplementation for women during pregnancy

PubMed Central

De-Regil, Luz Maria; Palacios, Cristina; Ansary, Ali; Kulier, Regina; Peña-Rosas, Juan Pablo

2013-01-01

Background Vitamin D deficiency or insufficiency is thought to be common among pregnant women. Vitamin D supplementation during pregnancy has been suggested as an intervention to protect against adverse gestational outcomes. Objectives To examine whether supplements with vitamin D alone or in combination with calcium or other vitamins and minerals given to women during pregnancy can safely improve maternal and neonatal outcomes. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2011), the International Clinical Trials Registry Platform (ICTRP) (31 October 2011), the Networked Digital Library of Theses and Dissertations (28 October 2011) and also contacted relevant organisations (8 April 2011). Selection criteria Randomised and quasi-randomised trials with randomisation at either individual or cluster level, evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy. Data collection and analysis Two review authors independently i) assessed the eligibility of studies against the inclusion criteria ii) extracted data from included studies, and iii) assessed the risk of bias of the included studies. Data were checked for accuracy. Main results The search strategy identified 34 potentially eligible references. We included six trials assessing a total of 1023 women, excluded eight studies, and 10 studies are still ongoing. Five trials involving 623 women compared the effects of vitamin D alone versus no supplementation/placebo and one trial with 400 women compared the effects of vitamin D and calcium versus no supplementation. Only one trial with 400 women reported on pre-eclampsia: women who received 1200 IU vitamin D along with 375 mg of elemental calcium per day were as likely to develop pre-eclampsia as women who received no supplementation (average risk ratio (RR) 0.67; 95% confidence interval (CI) 0.33 to 1.35). Data from four trials

Effect of zoledronic acid on serum calcium in Paget’s disease patients after educational strategies to improve calcium and vitamin D supplementation

PubMed Central

Bone, Henry G.; Su, Guoqin; Tan, Monique; Ozturk, Zafer E.; Aftring, Paul

2015-01-01

Objective: Bisphosphonates are the most effective therapeutic agents in patients with Paget’s disease of bone. As a result of their inhibition of osteoclastic activity, hypocalcemia of variable frequency and severity following intravenous bisphosphonate therapy has been reported. The present study assessed the effect of physician and patient education on adequate supplementation of calcium and vitamin D to reduce the potential risk of developing hypocalcemia following infusion of 5 mg zoledronic acid. Methods: This was an open-label, multicenter, controlled registry trial in which patients with Paget’s disease were treated with a single intravenous infusion of zoledronic acid. Physicians were provided with educational materials focusing on optimization of calcium and vitamin D supplementation following zoledronic infusion that they used to educate their patients. The primary safety variable was the percentage of patients with serum calcium level <2.07mmol/l 9–11 days after zoledronic acid infusion. Results: A total of 75 patients were evaluable in the post dose hypocalcemia safety analysis. Of these, only 1 patient had treatment-emergent hypocalcemia, with a serum calcium level of 1.92 mmol/l 4 days following therapy. Hypocalcemia-related symptoms were not reported in this patient and the serum calcium returned to normal range at 2.17 mmol/l within 1 week on oral calcium supplementation. Conclusions: These results suggest that, with optimization of calcium and vitamin D supplementation by physician and patient education, hypocalcemia is an infrequent occurrence following zoledronic acid infusion. PMID:26301065

Effect of vitamin D supplementation on blood pressure parameters in patients with vitamin D deficiency: a systematic review and meta-analysis.

PubMed

Shu, Liqin; Huang, Kun

2018-07-01

Evidence suggests that supplementation of vitamin D cannot decrease blood pressure in normal populations. However, in randomized controlled trials (RCTs) with vitamin D deficient participants (defined as baseline serum 25[OH]D levels <30 ng/mL or 50 nmol/L), this effect is inconsistent and under debate. Thus, we performed this systematic review and meta-analysis to evaluate whether vitamin D supplementation could affect blood pressure parameters in vitamin D-deficient subjects. The PubMed, Web of Science, ScienceDirect, and Cochrane library databases were searched. Extracted data were pooled as weighted mean differences with 95% confidence intervals to evaluate the effects. Subgroup analysis was further conducted according to the characteristics of included studies. Seven RCTs that contained 560 participants were included in our meta-analysis. The pooled weighted mean difference of peripheral diastolic blood pressure was -1.65 mm Hg (95% confidence interval: -3.05 to -0.25, I 2  = 30.3%). No significant effect of vitamin D supplementation was found on other parameters. Subgroup analysis showed a significant decrease in peripheral systolic blood pressure and diastolic blood pressure in Asia, 8 weeks of intervention, and more than 5000 IU of daily vitamin D supplementation subgroups. For vitamin D-deficient patients, there is a small but significant fall in peripheral blood pressure but no significant fall in other blood pressure parameters with vitamin D supplementation. Further RCTs with large numbers of participants is still warranted to confirm these effects. Copyright © 2018 American Heart Association. Published by Elsevier Inc. All rights reserved.

78 FR 8119 - Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-05

... the Herbert Hoover Dike Major Rehabilitation Project, Martin and Palm Beach Counties AGENCY...-wide risk reduction approach as required for safety modifications to dams. FOR FURTHER INFORMATION...-2108. SUPPLEMENTARY INFORMATION: The supplemental MRR will be replaced with a system-wide Dam Safety...

Linguistic analysis of large-scale medical incident reports for patient safety.

PubMed

Fujita, Katsuhide; Akiyama, Masanori; Park, Keunsik; Yamaguchi, Etsuko Nakagami; Furukawa, Hiroyuki

2012-01-01

The analysis of medical incident reports is indispensable for patient safety. The cycles between analysis of incident reports and proposals to medical staffs are a key point for improving the patient safety in the hospital. Most incident reports are composed from freely written descriptions, but an analysis of such free descriptions is not sufficient in the medical field. In this study, we aim to accumulate and reinterpret findings using structured incident information, to clarify improvements that should be made to solve the root cause of the accident, and to ensure safe medical treatment through such improvements. We employ natural language processing (NLP) and network analysis to identify effective categories of medical incident reports. Network analysis can find various relationships that are not only direct but also indirect. In addition, we compare bottom-up results obtained by NLP with existing categories based on experts' judgment. By the bottom-up analysis, the class of patient managements regarding patients' fallings and medicines in top-down analysis is created clearly. Finally, we present new perspectives on ways of improving patient safety.

Enhancing Safety of Artificially Ventilated Patients Using Ambient Process Analysis.

PubMed

Lins, Christian; Gerka, Alexander; Lüpkes, Christian; Röhrig, Rainer; Hein, Andreas

2018-01-01

In this paper, we present an approach for enhancing the safety of artificially ventilated patients using ambient process analysis. We propose to use an analysis system consisting of low-cost ambient sensors such as power sensor, RGB-D sensor, passage detector, and matrix infrared temperature sensor to reduce risks for artificially ventilated patients in both home and clinical environments. We describe the system concept and our implementation and show how the system can contribute to patient safety.

The effects of probiotics supplementation on metabolic health in pregnant women: An evidence based meta-analysis.

PubMed

Zheng, Jia; Feng, Qianyun; Zheng, Sheng; Xiao, Xinhua

2018-01-01

The prevalence of maternal obesity and gestational diabetes mellitus (GDM) is increasing rapidly. Probiotics supplementation have been shown to improve metabolic health in humans. In our study, we aimed to evaluate the effects of probiotics supplementation on metabolic health and pregnancy complications in pregnant women. The literature search, data extraction and quality assessment were performed, and data were synthesized in accordance with standardized guidelines. Ten randomized clinical trials with eligible data were included in our meta-analysis. For pregnant women with GDM, we found negative correlations between probiotics supplementation and fasting serum insulin (OR -2.94, 95%CI [-5.69, -0.20], p = 0.04) and homoeostasis model assessment for insulin resistance (HOMA-IR) (OR -0.65, 95%CI [-1.18, -0.11], p = 0.02). There were no significant correlations between probiotics supplementation and lipid levels in women with GDM, including total cholesterol (OR -2.72, 95%CI [-17.18, 11.74], P = 0.71), high density lipoprotein cholesterol (HDL-c) (OR -0.29, 95%CI [-3.60, 3.03], P = 0.87), low density lipoprotein cholesterol (LDL-c) (OR -0.38, 95%CI [-18.54, 17.79], P = 0.97), or triglycerides (OR -12.83, 95%CI [-36.63, 10.97], P = 0.29). For healthy pregnant women, probiotics supplementation were negatively associated with fasting serum insulin (OR -3.76, 95%CI [-4.29, -3.23], P < 0.00001) and HOMA-IR (OR -0.57, 95%CI [-1.08, -0.06], p = 0.03). However, no significant correlations were observed between probiotics supplementation and fasting plasma glucose (FPG) (OR -2.02, 95%CI [-5.56, 1.52], p = 0.26). Thus, our study revealed that probiotics supplementation during pregnancy have beneficial effects on glucose metabolism, rather than lipid metabolism among pregnant women.

The geography of patient safety: a topical analysis of sterility.

PubMed

Mesman, Jessica

2009-12-01

Many studies on patient safety are geared towards prevention of adverse events by eliminating causes of error. In this article, I argue that patient safety research needs to widen its analytical scope and include causes of strength as well. This change of focus enables me to ask other questions, like why don't things go wrong more often? Or, what is the significance of time and space for patient safety? The focal point of this article is on the spatial dimension of patient safety. To gain insight into the 'geography' of patient safety and perform a topical analysis, I will focus on one specific kind of space (sterile space), one specific medical procedure (insertion of an intravenous line) and one specific medical ward (neonatology). Based on ethnographic data from research in the Netherlands, I demonstrate how spatial arrangements produce sterility and how sterility work produces spatial orders at the same time. Detailed analysis shows how a sterile line insertion involves the convergence of spatially distributed resources, relocations of the field of activity, an assemblage of an infrastructure of attention, a specific compositional order of materials, and the scaling down of one's degree of mobility. Sterility, I will argue, turns out to be a product of spatial orderings. Simultaneously, sterility work generates particular spatial orders, like open and restricted areas, by producing buffers and boundaries. However, the spatial order of sterility intersects with the spatial order of other lines of activity. Insight into the normative structure of these co-existing spatial orders turns out to be crucial for patient safety. By analyzing processes of spatial fine-tuning in everyday practice, it becomes possible to identify spatial competences and circumstances that enable staff members to provide safe health care. As such, a topical analysis offers an alternative perspective of patient safety, one that takes into account its spatial dimension.

Accident analysis and control options in support of the sludge water system safety analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

HEY, B.E.

A hazards analysis was initiated for the SWS in July 2001 (SNF-8626, K Basin Sludge and Water System Preliminary Hazard Analysis) and updated in December 2001 (SNF-10020 Rev. 0, Hazard Evaluation for KE Sludge and Water System - Project A16) based on conceptual design information for the Sludge Retrieval System (SRS) and 60% design information for the cask and container. SNF-10020 was again revised in September 2002 to incorporate new hazards identified from final design information and from a What-if/Checklist evaluation of operational steps. The process hazards, controls, and qualitative consequence and frequency estimates taken from these efforts have beenmore » incorporated into Revision 5 of HNF-3960, K Basins Hazards Analysis. The hazards identification process documented in the above referenced reports utilized standard industrial safety techniques (AIChE 1992, Guidelines for Hazard Evaluation Procedures) to systematically guide several interdisciplinary teams through the system using a pre-established set of process parameters (e.g., flow, temperature, pressure) and guide words (e.g., high, low, more, less). The teams generally included representation from the U.S. Department of Energy (DOE), K Basins Nuclear Safety, T Plant Nuclear Safety, K Basin Industrial Safety, fire protection, project engineering, operations, and facility engineering.« less

An analysis of electronic health record-related patient safety concerns

PubMed Central

Meeks, Derek W; Smith, Michael W; Taylor, Lesley; Sittig, Dean F; Scott, Jean M; Singh, Hardeep

2014-01-01

Objective A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. Methods The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. Results We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR. Discussion EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. Conclusions Because EHR-related safety concerns have complex

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.

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... hazard from affecting the public. A launch operator must incorporate the launch site operator's systems... personnel who are knowledgeable of launch vehicle systems, launch processing, ground systems, operations...) Begin a ground safety analysis by identifying the systems and operations to be analyzed; (2) Define the...

14 CFR 417.405 - Ground safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... hazard from affecting the public. A launch operator must incorporate the launch site operator's systems... personnel who are knowledgeable of launch vehicle systems, launch processing, ground systems, operations...) Begin a ground safety analysis by identifying the systems and operations to be analyzed; (2) Define the...

Meta-Analysis: Effects of Probiotic Supplementation on Lipid Profiles in Normal to Mildly Hypercholesterolemic Individuals.

PubMed

Shimizu, Mikiko; Hashiguchi, Masayuki; Shiga, Tsuyoshi; Tamura, Hiro-omi; Mochizuki, Mayumi

2015-01-01

Recent experimental and clinical studies have suggested that probiotic supplementation has beneficial effects on serum lipid profiles. However, there are conflicting results on the efficacy of probiotic preparations in reducing serum cholesterol. To evaluate the effects of probiotics on human serum lipid levels, we conducted a meta-analysis of interventional studies. Eligible reports were obtained by searches of electronic databases. We included randomized, controlled clinical trials comparing probiotic supplementation with placebo or no treatment (control). Statistical analysis was performed with Review Manager 5.3.3. Subanalyses were also performed. Eleven of 33 randomized clinical trials retrieved were eligible for inclusion in the meta-analysis. No participant had received any cholesterol-lowering agent. Probiotic interventions (including fermented milk products and probiotics) produced changes in total cholesterol (TC) (mean difference -0.17 mmol/L, 95% CI: -0.27 to -0.07 mmol/L) and low-density lipoprotein cholesterol (LDL-C) (mean difference -0.22 mmol/L, 95% CI: -0.30 to -0.13 mmol/L). High-density lipoprotein cholesterol and triglyceride levels did not differ significantly between probiotic and control groups. In subanalysis, long-term (> 4-week) probiotic intervention was statistically more effective in decreasing TC and LDL-C than short-term (≤ 4-week) intervention. The decreases in TC and LDL-C levels with probiotic intervention were greater in mildly hypercholesterolemic than in normocholesterolemic individuals. Both fermented milk product and probiotic preparations decreased TC and LDL-C levels. Gaio and the Lactobacillus acidophilus strain reduced TC and LDL-C levels to a greater extent than other bacterial strains. In conclusion, this meta-analysis showed that probiotic supplementation could be useful in the primary prevention of hypercholesterolemia and may lead to reductions in risk factors for cardiovascular disease.

Meta-Analysis: Effects of Probiotic Supplementation on Lipid Profiles in Normal to Mildly Hypercholesterolemic Individuals

PubMed Central

Shimizu, Mikiko; Hashiguchi, Masayuki; Shiga, Tsuyoshi; Tamura, Hiro-omi; Mochizuki, Mayumi

2015-01-01

Introduction Recent experimental and clinical studies have suggested that probiotic supplementation has beneficial effects on serum lipid profiles. However, there are conflicting results on the efficacy of probiotic preparations in reducing serum cholesterol. Objective To evaluate the effects of probiotics on human serum lipid levels, we conducted a meta-analysis of interventional studies. Methods Eligible reports were obtained by searches of electronic databases. We included randomized, controlled clinical trials comparing probiotic supplementation with placebo or no treatment (control). Statistical analysis was performed with Review Manager 5.3.3. Subanalyses were also performed. Results Eleven of 33 randomized clinical trials retrieved were eligible for inclusion in the meta-analysis. No participant had received any cholesterol-lowering agent. Probiotic interventions (including fermented milk products and probiotics) produced changes in total cholesterol (TC) (mean difference –0.17 mmol/L, 95% CI: –0.27 to –0.07 mmol/L) and low-density lipoprotein cholesterol (LDL-C) (mean difference –0.22 mmol/L, 95% CI: –0.30 to –0.13 mmol/L). High-density lipoprotein cholesterol and triglyceride levels did not differ significantly between probiotic and control groups. In subanalysis, long-term (>4-week) probiotic intervention was statistically more effective in decreasing TC and LDL-C than short-term (≤4-week) intervention. The decreases in TC and LDL-C levels with probiotic intervention were greater in mildly hypercholesterolemic than in normocholesterolemic individuals. Both fermented milk product and probiotic preparations decreased TC and LDL-C levels. Gaio and the Lactobacillus acidophilus strain reduced TC and LDL-C levels to a greater extent than other bacterial strains. Conclusions In conclusion, this meta-analysis showed that probiotic supplementation could be useful in the primary prevention of hypercholesterolemia and may lead to reductions in risk

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.

GC-MS analysis of the ruminal metabolome response to thiamine supplementation during high grain feeding in dairy cows.

PubMed

Xue, Fuguang; Pan, Xiaohua; Jiang, Linshu; Guo, Yuming; Xiong, Benhai

2018-01-01

Thiamine is known to attenuate high-concentrate diet induced subacute ruminal acidosis (SARA) in dairy cows, however, the underlying mechanisms remain unclear. The major objective of this study was to investigate the metabolic mechanisms of thiamine supplementation on high-concentrate diet induced SARA. Six multiparous, rumen-fistulated Holstein cows were used in a replicated 3 × 3 Latin square design. The treatments included a control diet (CON; 20% starch, dry matter basis), a SARA-inducing diet (SAID; 33.2% starch, dry matter basis) and SARA-inducing diet supplemented with 180 mg of thiamine/kg of dry matter intake (SAID + T). On d21 of each period, ruminal fluid samples were collected at 3 h post feeding, and GC/MS was used to analyze rumen fluid samples. PCA and OPLS-DA analysis demonstrated that the ruminal metabolite profile were different in three treatments. Compared with CON treatment, SAID feeding significantly decreased rumen pH, acetate, succinic acid, increased propionate, pyruvate, lactate, glycine and biogenic amines including spermidine and putrescine. Thiamine supplementation significantly decreased rumen content of propionate, pyruvate, lactate, glycine and spermidine; increase rumen pH, acetate and some medium-chain fatty acids. The enrichment analysis of different metabolites indicated that thiamine supplementation mainly affected carbohydrates, amino acids, pyruvate and thiamine metabolism compared with SAID treatment. These findings revealed that thiamine supplementation could attenuate high-concentrate diet induced SARA by increasing pyruvate formate-lyase activity to promote pyruvate to generate acetyl-CoA and inhibit lactate generation. Besides, thiamine reduced biogenic amines to alleviate ruminal epithelial inflammatory response.

The effect of long chain polyunsaturated fatty acid supplementation on intelligence in low birth weight infant during lactation: A meta-analysis

PubMed Central

Song, Yuan; Liu, Ya; Pan, Yun; Yuan, Xiaofeng; Chang, Pengyu; Tian, Yuan; Cui, Weiwei

2018-01-01

Background Low birth weight infant (LBWIs) are prone to mental and behavioural problems. As an important constituent of the brain and retina, long chain polyunsaturated fatty acids are essential for foetal infant mental and visual development. The effect of lactation supplemented with long chain polyunsaturated fatty acids (LCPUFA) on the improvement of intelligence in low birth weight children requires further validation. Methods In this study, a comprehensive search of multiple databases was performed to identify studies focused the association between intelligence and long chain polyunsaturated fatty acid supplementation in LBWIs. Studies that compared the Bayley Scales of Infant Development (BSID) or the Wechsler Abbreviated Scale of Intelligence for Children (WISC) scores between LBWIs who were supplemented and controls that were not supplemented with LCPUFA during lactation were selected for inclusion in the meta-analysis. Results The main outcome was the mean difference in the mental development index (MDI) and psychomotor development index (PDI) of the BSID and the full scale intelligence quotient (FSIQ), verbal intelligence quotient (VIQ) and performance intelligence quotient (PIQ) of the WISC between LBWIs and controls. Our findings indicated that the mean BSID or WISC scores in LBWIs did not differ between the supplemented groups and controls. Conclusion This meta-analysis does not reveal that LCPUFA supplementation has a significant impact on the level of intelligence in LBWIs. PMID:29634752

Putting Safety First in the Sky

NASA Technical Reports Server (NTRS)

2003-01-01

As a result of technology developed at NASA s Kennedy Space Center, pilots now have a hand-held personal safety device to warn them of potentially dangerous or deteriorating cabin pressure altitude conditions before hypoxia becomes a threat. The Personal Cabin Pressure Altitude Monitor and Warning System monitors cabin pressure to determine when supplemental oxygen should be used according to Federal Aviation Regulations. The device benefits both pressurized and nonpressurized aircraft operations - warning pressurized aircraft when the required safe cabin pressure altitude is compromised, and reminding nonpressurized aircraft when supplemental oxygen is needed.

Optimization of coupled multiphysics methodology for safety analysis of pebble bed modular reactor

NASA Astrophysics Data System (ADS)

Mkhabela, Peter Tshepo

methodology for the PBMR to provide reference solutions. Investigation of different aspects of the coupled methodology and development of efficient kinetics treatment for the PBMR were carried out, which accounts for all feedback phenomena in an efficient manner. The OECD/NEA PBMR-400 coupled code benchmark was used as a test matrix for the proposed investigations. The integrated thermal-hydraulics and neutronics (multi-physics) methods were extended to enable modeling of a wider range of transients pertinent to the PBMR. First, the effect of the spatial mapping schemes (spatial coupling) was studied and quantified for different types of transients, which resulted in implementation of improved mapping methodology based on user defined criteria. The second aspect that was studied and optimized is the temporal coupling and meshing schemes between the neutronics and thermal-hydraulics time step selection algorithms. The coupled code convergence was achieved supplemented by application of methods to accelerate it. Finally, the modeling of all feedback phenomena in PBMRs was investigated and a novel treatment of cross-section dependencies was introduced for improving the representation of cross-section variations. The added benefit was that in the process of studying and improving the coupled multi-physics methodology more insight was gained into the physics and dynamics of PBMR, which will help also to optimize the PBMR design and improve its safety. One unique contribution of the PhD research is the investigation of the importance of the correct representation of the three-dimensional (3-D) effects in the PBMR analysis. The performed studies demonstrated that explicit 3-D modeling of control rod movement is superior and removes the errors associated with the grey curtain (2-D homogenized) approximation.

Effects of supplementation with the fat-soluble vitamins E and D on fasting flow-mediated vasodilation in adults: a meta-analysis of randomized controlled trials.

PubMed

Joris, Peter J; Mensink, Ronald P

2015-03-10

The effects of fat-soluble vitamin supplementation on cardiovascular disease (CVD) risk are not clear. Therefore, we performed a meta-analysis to quantify effects of fat-soluble vitamin supplements on fasting flow-mediated vasodilation (FMD) of the brachial artery, a validated marker to assess CVD risk. Randomized placebo-controlled trials (RCTs) were identified by a systematic search till July 2014. Seven RCTs studying the effects of vitamin E supplements (range: 300 to 1800 IU per day) and nine RCTs examining the effects of vitamin D supplements, that involved, respectively, 303 and 658 adults, were included. No studies with carotenoid or vitamin K supplements were found. Vitamin E supplementation increased FMD vs. control by 2.42% (95% CI: 0.46% to 4.37%; p = 0.015). No effects of vitamin D supplementation were found (0.15%; 95% CI: -0.21% to 0.51%; p = 0.41). These effects did not depend on subject characteristics, treatment characteristics or technical aspects of the FMD measurement. However, no dose-response relationship was evident for vitamin E, statistical significance depended on one study, while the levels of supplement were far above recommended intakes. The current meta-analysis, therefore, does not provide unambiguous evidence to support the use of fat-soluble vitamin supplements to improve fasting FMD in adults.

78 FR 8119 - Cancellation of the Notice of Intent To Prepare a Draft and Final Supplemental Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-05

... the Herbert Hoover Dike Major Rehabilitation Project, Palm Beach and Glades Counties, FL AGENCY... safety modifications to dams. FOR FURTHER INFORMATION CONTACT: Questions may be forwarded to Ms. Angela... supplemental MRR will be replaced with a system wide Dam Safety Modification (DSM) Report. Environmental...

Acute liver injury following Garcinia cambogia weight-loss supplementation: case series and literature review.

PubMed

Crescioli, Giada; Lombardi, Niccolò; Bettiol, Alessandra; Marconi, Ettore; Risaliti, Filippo; Bertoni, Michele; Menniti Ippolito, Francesca; Maggini, Valentina; Gallo, Eugenia; Firenzuoli, Fabio; Vannacci, Alfredo

2018-05-25

Herbal weight-loss supplements are sold as self-medication products, and are often used under the misconception that their natural origin guarantees their safety. Food supplements are not required to provide any benefit/risk profile evaluation before marketing; however, possible risks associated with use of herbal extracts in food supplements are becoming more and more documented in the literature. Some herbs are listed as the leading cause of herb-induced liver injury, with a severe or potentially lethal clinical course, and unpredictable herb-drug interactions. Garcinia cambogia (GC) extract and GC-containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we present four cases of acute liver failure in women taking GC extract for weight loss, and a literature review of clinical evidences about hepatic toxicity in patients taking dietary supplements containing GC extract.

Health risk appraisal and safety belt use

DOT National Transportation Integrated Search

1987-05-01

The primary objective of this study was to determine the effectiveness of health risk appraisal (HRA) programs for increasing claimed and observed safety belt use. HRA programs were field tested with and without supplemental educational materials on ...

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.

Tomato and lycopene supplementation and cardiovascular risk factors: A systematic review and meta-analysis.

PubMed

Cheng, Ho Ming; Koutsidis, Georgios; Lodge, John K; Ashor, Ammar; Siervo, Mario; Lara, José

2017-02-01

Epidemiological evidence suggests an association between consumption of tomato products or lycopene and lower risk for cardiovascular diseases (CVD). Our aim was to evaluate the state of the evidence from intervention trials on the effect of consuming tomato products and lycopene on markers of cardiovascular (CV) function. We undertook a systematic review and meta-analysis on the effect of supplementing tomato and lycopene on CV risk factors. Three databases including Medline, Web of science, and Scopus were searched from inception to August 2016. Inclusion criteria were: intervention trials reporting effects of tomato products and lycopene supplementation on CV risk factors among adult subjects >18 years of age. The outcomes of interest included blood lipids (total-, HDL-, LDL-cholesterol, triglycerides, oxidised-LDL), endothelial function (flow-mediated dilation (FMD), pulse wave velocity (PWV)) and blood pressure (BP) inflammatory factors (CRP, IL-6) and adhesion molecules (ICAM-1). Random-effects models were used to determine the pooled effect sizes. Out of 1189 publications identified, 21 fulfilled inclusion criteria and were meta-analysed. Overall, interventions supplementing tomato were associated with significant reductions in LDL-cholesterol (-0.22 mmol/L; p = 0.006), IL-6 (standardised mean difference -0.25; p = 0.03), and improvements in FMD (2.53%; p = 0.01); while lycopene supplementation reduced systolic-BP (-5.66 mmHg; p = 0.002). No other outcome was significantly affected by these interventions. The available evidence on the effects of tomato products and lycopene supplementation on CV risk factors supports the view that increasing the intake of these has positive effects on blood lipids, blood pressure and endothelial function. These results support the development of promising individualised nutritional strategies involving tomatoes to tackle CVD. Copyright © 2017 Elsevier B.V. All rights reserved.

Hepatopathy following consumption of a commercially available blue-green algae dietary supplement in a dog.

PubMed

Bautista, Adrienne C; Moore, Caroline E; Lin, Yanping; Cline, Martha G; Benitah, Noemi; Puschner, Birgit

2015-06-19

Dietary supplement use in both human and animals to augment overall health continues to increase and represents a potential health risk due to the lack of safety regulations imposed on the manufacturers. Because there are no requirements for demonstrating safety and efficacy prior to marketing, dietary supplements may contain potentially toxic contaminants such as hepatotoxic microcystins produced by several species of blue-green algae. An 11-year-old female spayed 8.95 kg Pug dog was initially presented for poor appetite, lethargy polyuria, polydipsia, and an inability to get comfortable. Markedly increased liver enzyme activities were detected with no corresponding abnormalities evident on abdominal ultrasound. A few days later the liver enzyme activities were persistently increased and the dog was coagulopathic indicating substantial liver dysfunction. The dog was hospitalized for further care consisting of oral S-adenosylmethionine, silybin, vitamin K, and ursodeoxycholic acid, as well as intravenous ampicillin sodium/sulbactam sodium, dolasetron, N-acetylcysteine, metoclopramide, and intravenous fluids. Improvement of the hepatopathy and the dog's clinical status was noted over the next three days. Assessment of the dog's diet revealed the use of a commercially available blue-green algae dietary supplement for three-and-a-half weeks prior to hospitalization. The supplement was submitted for toxicology testing and revealed the presence of hepatotoxic microcystins (MCs), MC-LR and MC-LA. Use of the supplement was discontinued and follow-up evaluation over the next few weeks revealed a complete resolution of the hepatopathy. To the authors' knowledge, this is the first case report of microcystin intoxication in a dog after using a commercially available blue-green algae dietary supplement. Veterinarians should recognize the potential harm that these supplements may cause and know that with intervention, recovery is possible. In addition, more prudent oversight of

Hazard Identification and Risk Assessment of Health and Safety Approach JSA (Job Safety Analysis) in Plantation Company

NASA Astrophysics Data System (ADS)

Sugarindra, Muchamad; Ragil Suryoputro, Muhammad; Tiya Novitasari, Adi

2017-06-01

Plantation company needed to identify hazard and perform risk assessment as an Identification of Hazard and Risk Assessment Crime and Safety which was approached by using JSA (Job Safety Analysis). The identification was aimed to identify the potential hazards that might be the risk of workplace accidents so that preventive action could be taken to minimize the accidents. The data was collected by direct observation to the workers concerned and the results were recorded on a Job Safety Analysis form. The data were as forklift operator, macerator worker, worker’s creeper, shredder worker, workers’ workshop, mechanical line worker, trolley cleaning workers and workers’ crepe decline. The result showed that shredder worker value was 30 and had the working level with extreme risk with the risk value range was above 20. So to minimize the accidents could provide Personal Protective Equipment (PPE) which were appropriate, information about health and safety, the company should have watched the activities of workers, and rewards for the workers who obey the rules that applied in the plantation.

Technical noise supplement : TeNS : a technical supplement to the Traffic Noise Analysis Protocol.

DOT National Transportation Integrated Search

1998-10-01

The purpose of this Technical Noise Supplement (TeNS) is to provide technical background : information on transportation-related noise in general and highway traffic noise in : particular. It is designed to elaborate on technical concepts and procedu...

Resveratrol supplementation and plasma adipokines concentrations? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Mohammadi-Sartang, Mohsen; Mazloom, Zohreh; Sohrabi, Zahra; Sherafatmanesh, Saeed; Barati-Boldaji, Reza

2017-03-01

The results of human clinical trials have revealed that the effects of resveratrol on adipokines are inconsistent. Our objective was to elucidate the role of resveratrol supplementation on adipokines through a systematic review and a meta-analysis of available randomized placebo-controlled trials (RCTs). 1 The search included PubMed-MEDLINE, SCOPUS and ISI web of sciences database till up to 6th November 2016. Weight mean differences (WMD) 2 were calculated for net changes in adipokines using fixed-effects or random-effects models; meta-regression analysis and publication bias were conducted in accordance with standard methods. Nine RCTs with 11 treatment arms were eligible for inclusion in this systematic review and meta-analysis. Meta-analysis of data from 10 treatment arms showed a significant change in plasma adiponectin concentrations following resveratrol supplementation (WMD: 1.10μg/ml, 95%CI: 0.88, 1.33, p<0.001); Q=11.43, I 2 =21.29%, p=0.247). There was a significant greater adiponectin-reducing effect in trials with higher than or equal to 100mg/day (WMD: 1.11μg/ml, 95%CI: 0.88, 1.34, p<0.001), versus those with less than 100 mg/day dosage (WMD: 0.84μg/ml, 95%CI: -0.62, 2.31, p=0.260). Meta-analysis of data from 5 treatment arms did not find any significant change in plasma leptin concentrations following resveratrol supplementation (WMD: 3.77ng/ml, 95% CI: -2.28, 9.83, p=0.222; Q=8.00, I 2 =50.01%). Resveratrol significantly improves adiponectin but does not affect leptin concentrations. Additional studies are required to further evaluate the potential benefits of resveratrol on adipokines in humans. Copyright © 2017. Published by Elsevier Ltd.

The effect of glutamine supplementation on athletic performance, body composition, and immune function: A systematic review and a meta-analysis of clinical trials.

PubMed

Ramezani Ahmadi, Amirhossein; Rayyani, Elham; Bahreini, Mehdi; Mansoori, Anahita

2018-05-09

This systematic review and meta-analysis of available evidence was conducted to obtain a conclusive result on the effects of glutamine supplementation on athletes. Systematic review and meta-analysis. Data related to body mass, lean body mass, body fat percentage, Vo2 max, lymphocytes, leukocytes and neutrophil counts were extracted to determine the effects of GLN on performance outcomes. The literature search was conducted across the databases Pubmed, Scopus, ISI Web of Science, SID (Scientific Information Database) and Cochrane Central Register of Controlled Trials, covering a period up to January 2017. Clinical trials evaluating glutamine supplementation outcomes on athletes aged over 18 were included. A total of 47 studies were included in the systematic review, and 25 trials matched the inclusion criteria for the meta-analysis. According to the meta-analysis, glutamine has a significant effect on weight reduction (WMD = -1.36 [95% CI: -2.55 to -0.16], p = 0.02). Moreover, neutrophil numbers were reduced following glutamine intake at doses greater than 200 mg/kg body weight (WMD = -605.77 [95% CI: -1200.0 to 52.1]; P = 0.03). Also, supplementation by glutamine dipeptide resulted in higher blood glucose after exercise (WMD = 0.51 [95% CI: 0.18, 0.83] mmol/l; P = 0.002). There was no association between glutamine ingestion and other outcomes investigated. According to this meta-analysis, generally, glutamine supplementation has no effect on athletics immune system, aerobic performance, and body composition. However, the current study showed that glutamine resulted in greater weight reduction. In addition, the present study suggests that the efficacy of glutamine supplementation on neutrophil numbers could be affected by supplement type and dose. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Comparison of a Traditional Probabilistic Risk Assessment Approach with Advanced Safety Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Curtis L; Mandelli, Diego; Zhegang Ma

2014-11-01

As part of the Light Water Sustainability Program (LWRS) [1], the purpose of the Risk Informed Safety Margin Characterization (RISMC) [2] Pathway research and development (R&D) is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” (SBO) wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe themore » RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario. We also describe our approach we are using to represent advanced flooding analysis.« less

Effects of infant formula supplemented with prebiotics compared with synbiotics on growth up to the age of 12 mo: a randomized controlled trial.

PubMed

Szajewska, Hania; Ruszczyński, Marek; Szymański, Henryk; Sadowska-Krawczenko, Iwona; Piwowarczyk, Anna; Rasmussen, Preben Bødstrup; Kristensen, Mette Bach; West, Christina E; Hernell, Olle

2017-05-01

Growth is an essential outcome measure for evaluating the safety of infant formulas (IF). We investigated the effects of consumption of IF supplemented with prebiotics (fructooligosaccharides, FOS, and galactooligosaccharides, GOS) compared with synbiotics (FOS/GOS and Lactobacillus paracasei ssp. paracasei strain F19) on the growth of healthy infants. 182 full-term infants who were weaned completely from breast milk to IF at 28 d of age were randomly assigned to receive prebiotic- or synbiotic-supplemented, otherwise identical, IF until 6 mo of age (intervention period). A total of 146 (80%) infants were included in the intention-to-treat analysis at 6 mo. Anthropometric parameters were similar in the two groups during the intervention and follow-up period until 12 mo of age. Compared with the prebiotic group, a significant reduction in the cumulative incidence of lower respiratory tract infections was found in the synbiotic group; however, the confidence interval of the estimate was wide, resulting in uncertainty. The lack of a significant difference between the formula-fed groups in growth, or the occurrence of serious adverse events, supports the safety of using IF supplemented with synbiotics. Further studies are needed to evaluate the effects of such formula on lower-respiratory tract infections.

Integrated Safety Analysis Teams

NASA Technical Reports Server (NTRS)

Wetherholt, Jonathan C.

2008-01-01

Today's complex systems require understanding beyond one person s capability to comprehend. Each system requires a team to divide the system into understandable subsystems which can then be analyzed with an Integrated Hazard Analysis. The team must have both specific experiences and diversity of experience. Safety experience and system understanding are not always manifested in one individual. Group dynamics make the difference between success and failure as well as the difference between a difficult task and a rewarding experience. There are examples in the news which demonstrate the need to connect the pieces of a system into a complete picture. The Columbia disaster is now a standard example of a low consequence hazard in one part of the system; the External Tank is a catastrophic hazard cause for a companion subsystem, the Space Shuttle Orbiter. The interaction between the hardware, the manufacturing process, the handling, and the operations contributed to the problem. Each of these had analysis performed, but who constituted the team which integrated this analysis together? This paper will explore some of the methods used for dividing up a complex system; and how one integration team has analyzed the parts. How this analysis has been documented in one particular launch space vehicle case will also be discussed.

Safety analysis, risk assessment, and risk acceptance criteria

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities andmore » that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.« less

41 CFR 102-80.130 - Who must perform the equivalent level of safety analysis?

Code of Federal Regulations, 2010 CFR

2010-07-01

...-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and Fire Prevention Equivalent Level of Safety Analysis... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who must perform the equivalent level of safety analysis? 102-80.130 Section 102-80.130 Public Contracts and Property Management...

Alpha-lipoic acid supplement in obesity treatment: A systematic review and meta-analysis of clinical trials.

PubMed

Namazi, Nazli; Larijani, Bagher; Azadbakht, Leila

2018-04-01

Previous studies have supported positive roles of antioxidant supplements on weight-loss. One antioxidant supplement is Alpha-lipoic acid. However, recommending ALA as an anti-obesity supplement remains controversial. Accordingly, the purpose of the present study was to perform a meta-analysis on the effects of ALA supplement on anthropometric indices among adult subjects. We searched five electronic databases till September 2016. Placebo-controlled clinical trials were included. Weighted Mean Difference (WMD) was pooled using a random-effects model. Findings of 12 included trials indicated that ALA supplement reduced body weight (WMD: -0.69 kg; 95% CI: -1.27, -0.10; I 2  = 0%) and BMI (WMD: -0.38 kg/m 2 ; 95% CI: -0.53, -0.24; I 2  = 0%) significantly compared to the placebo group. However, its effects on Waist Circumference (WC) was not significant (WMD: -0.30 cm; 95% CI: -1.18, 0.58; I 2  = 17.8%). Stratification by health status indicated that ALA decreased WC in unhealthy subjects (WMD: -2.00 cm; 95% CI: -4.19, 0.19; I 2  = 1.3%) more than healthy individuals (0.03 cm; 95% CI: -0.69, 0.75; I 2  = 0%). The present study revealed that supplementation with ALA slightly but significantly decreased body weight and BMI. Safe dosage for ALA is up to 1200 mg/day. However, it seems that ALA cannot be cost-effective. Further studies are needed to clarify the effects of ALA on metabolic parameter in unhealthy obese individuals. Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes

Management system of health and safety work (SMK3) with job safety analysis (JSA) in PT. Nira Murni construction

NASA Astrophysics Data System (ADS)

Melliana, Armen, Yusrizal, Akmal, Syarifah

2017-11-01

PT Nira Murni construction is a contractor of PT Chevron Pacific Indonesia which engaged in contractor, fabrication, maintenance construction suppliers, and labor services. The high of accident rate in this company is caused the lack of awareness of workplace safety. Therefore, it requires an effort to reduce the accident rate on the company so that the financial losses can be minimized. In this study, Safe T-Score method is used to analyze the accident rate by measuring the level of frequency. Analysis is continued using risk management methods which identify hazards, risk measurement and risk management. The last analysis uses Job safety analysis (JSA) which will identify the effect of accidents. From the result of this study can be concluded that Job Safety Analysis (JSA) methods has not been implemented properly. Therefore, JSA method needs to follow-up in the next study, so that can be well applied as prevention of occupational accidents.

Supplement Analysis for the Grande Ronde Basin Endemic Spring Chinook Salmon Supplementation Program EA (DOE/EA-1173/SA-01)

DOE Office of Scientific and Technical Information (OSTI.GOV)

N /A

2003-12-18

The CTUIR and ODFW propose to expand their monitoring and evaluation for the Grande Ronde spring chinook supplementation program to take additional data on summer steelhead that are trapped at the existing adult collection weirs on the upper Grande Ronde River and Catherine Creek. The weirs are a movable design and are operated seasonally during the adult chinook migration. Bull trout and summer steelhead have been trapped at the weirs since 1997 incidental to the spring chinook broodstock collection activities. Minimal data is recorded on both species as a requirement of the ESA permits, and reported to USFWS and NOAAmore » Fisheries. This supplement analysis covers a minor expansion of the program to collect more extensive life history data on summer steelhead. The weir and trap will be installed 2-3 weeks earlier (early to mid-March) than was previously needed for the spring chinook broodstock collection in order to monitor the summer steelhead migration period. The adult steelhead will be captured in the traps, anesthetized, and measured. Data will be recorded on the date of capture, fork length, sex, markings, and maturity of the fish, and scale and punch tissue samples will be taken for genetic analyses.« less

[Risk assessment of synephrine in dietary supplements].

PubMed

Bakhyia, Nadiya; Dusemund, Birgit; Richter, Klaus; Lindtner, Oliver; Hirsch-Ernst, Karen Ildico; Schäfer, Bernd; Lampen, Alfonso

2017-03-01

Synephrine is a sympathomimetic phenylethylamine derivative that occurs naturally in citrus fruits. It is often added to dietary supplements intended for weight loss and enhancement of sports performance, typically in the form of Citrus aurantium extracts and in many cases in combination with caffeine. The health risks of synephrine were evaluated on the basis of the available toxicological data and in accordance to the EFSA guidance on the safety assessment of botanicals and botanical preparations intended for use in food supplements. In animal studies, orally applied synephrine induced adrenergic effects on the cardiovascular system (increase of blood pressure, ventricular arrhythmias), which were enhanced by the concomitant application of caffeine as well as physical activity. Some human intervention studies investigating the acute effects of synephrine on blood pressure and heart rate of healthy, normotensive test persons indicate that synephrine can induce cardiovascular effects in humans. A series of published case reports of adverse cardiovascular effects (hypertension, cardiac arrhythmia, myocardial infarction) were associated with consumption of synephrine- and caffeine-containing dietary supplements. In conclusion, consumption of high amounts of synephrine, especially in combination with caffeine and physical exercise, is associated with an increased risk of adverse effects on the cardiovascular system. According to the assessment by the BfR (Bundesinstitut für Risikobewertung), daily intake of synephrine through dietary supplements should not exceed the median intake from conventional foods.

Sensitivity analysis in practice: providing an uncertainty budget when applying supplement 1 to the GUM

NASA Astrophysics Data System (ADS)

Allard, Alexandre; Fischer, Nicolas

2018-06-01

Sensitivity analysis associated with the evaluation of measurement uncertainty is a very important tool for the metrologist, enabling them to provide an uncertainty budget and to gain a better understanding of the measurand and the underlying measurement process. Using the GUM uncertainty framework, the contribution of an input quantity to the variance of the output quantity is obtained through so-called ‘sensitivity coefficients’. In contrast, such coefficients are no longer computed in cases where a Monte-Carlo method is used. In such a case, supplement 1 to the GUM suggests varying the input quantities one at a time, which is not an efficient method and may provide incorrect contributions to the variance in cases where significant interactions arise. This paper proposes different methods for the elaboration of the uncertainty budget associated with a Monte Carlo method. An application to the mass calibration example described in supplement 1 to the GUM is performed with the corresponding R code for implementation. Finally, guidance is given for choosing a method, including suggestions for a future revision of supplement 1 to the GUM.

Analysis of microgravity space experiments Space Shuttle programmatic safety requirements

NASA Technical Reports Server (NTRS)

Terlep, Judith A.

1996-01-01

This report documents the results of an analysis of microgravity space experiments space shuttle programmatic safety requirements and recommends the creation of a Safety Compliance Data Package (SCDP) Template for both flight and ground processes. These templates detail the programmatic requirements necessary to produce a complete SCDP. The templates were developed from various NASA centers' requirement documents, previously written guidelines on safety data packages, and from personal experiences. The templates are included in the back as part of this report.