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Dietary Supplements: Regulatory Challenges and Research Resources
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.
Journal Article
Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States
In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.
Journal Article
Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial
AbstractObjectiveTo assess the effects of food supplementation on improving working memory and additional measures including cerebral blood flow in children at risk of undernutrition.DesignRandomized controlled trial.Setting10 villages in Guinea-Bissau.Participants1059 children aged 15 months to 7 years; children younger than 4 were the primary population.InterventionsSupervised isocaloric servings (≈1300 kJ, five mornings each week, 23 weeks) of a new food supplement (NEWSUP, high in plant polyphenols and omega 3 fatty acids, within a wide variety and high fortification of micronutrients, and a high protein content), or a fortified blended food (FBF) used in nutrition programs, or a control meal (traditional rice breakfast).Main outcome measurementsThe primary outcome was working memory, a core executive function predicting long term academic achievement. Additional outcomes were hemoglobin concentration, growth, body composition, and index of cerebral blood flow (CBFi). In addition to an intention-to-treat analysis, a predefined per protocol analysis was conducted in children who consumed at least 75% of the supplement (820/925, 89%). The primary outcome was assessed by a multivariable Poisson model; other outcomes were assessed by multivariable linear mixed models.ResultsAmong children younger than 4, randomization to NEWSUP increased working memory compared with the control meal (rate ratio 1.20, 95% confidence interval 1.02 to 1.41, P=0.03), with a larger effect in the per protocol population (1.25, 1.06 to 1.47, P=0.009). NEWSUP also increased hemoglobin concentration among children with anemia (adjusted mean difference 0.65 g/dL, 95% confidence interval 0.23 to 1.07, P=0.003) compared with the control meal, decreased body mass index z score gain (−0.23, −0.43 to −0.02, P=0.03), and increased lean tissue accretion (2.98 cm2, 0.04 to 5.92, P=0.046) with less fat (−5.82 cm2, −11.28 to −0.36, P=0.04) compared with FBF. Additionally, NEWSUP increased CBFi compared with the control meal and FBF in both age groups combined (1.14 mm2/s×10−8, 0.10 to 2.23, P=0.04 for both comparisons). Among children aged 4 and older, NEWSUP had no significant effect on working memory or anemia, but increased lean tissue compared with FBF (4.31 cm2, 0.34 to 8.28, P=0.03).ConclusionsChildhood undernutrition is associated with long term impairment in cognition. Contrary to current understanding, supplementary feeding for 23 weeks could improve executive function, brain health, and nutritional status in vulnerable young children living in low income countries. Further research is needed to optimize nutritional prescriptions for regenerative improvements in cognitive function, and to test effectiveness in other vulnerable groups.Trial registrationClinicalTrials.gov NCT03017209.
Journal Article
Dietary supplements : safety, efficacy, and quality
Dietary supplements made from foods, herbs and their constituents are a rapidly growing market sector. Consumers often view food supplements as 'natural' and therefore safe; however, supplements are regulated as foods rather than as pharmaceuticals and so are not as closely monitored as may be necessary. With the commercial market in these products growing, this book provides essential research into their safety, efficacy and potential risk of interaction with pharmaceuticals.
Book
Effects of an Acute Dose of Zinc Monomethionine Asparate and Magnesium Asparate
The goal of the present study was to determine whether an acute dose of a zinc-containing nutritional supplement (ZMA) has any effects on sleep and morning performance in recreationally trained males. Nineteen males participated in a repeated-measures within-subjects study to assess objective and subjective measures of sleep, completed counter-movement jumps (CMJ) and repeated sprint morning performance (RSP). Three days of baseline food intake showed no major deficiencies of zinc, magnesium or vitamin B6 for all participants (11.9 ± 3.4, 395 ± 103 and 2.7 ± 0.9 mg.day[sup.−1], respectively). Sleep (22:30–06:30 h) was assessed via actimetry, and either a control (no tablets, NoPill), dextrose placebo (PLAC) or ZMA was ingested 30–60 min before retiring to bed for two nights. The participants undertook the three conditions (NoPill, PLAC or ZMA) administered in a counterbalanced order. The data were analyzed using general linear models with repeated measures. In healthy active males who consume diets of adequate micronutrients, sleep normally and maintain good sleep hygiene (time to bed and wake times), ZMA supplementation had no beneficial effect on RSP or performance in the Stroop test (p > 0.05) but did improve CMJ height (p < 0.001) compared to that of PLAC but not NoPill (p > 0.05). Supplementation of ZMA for two nights had no effect on sleep, RSP or cognitive function. The NoPill condition elucidated the effects of the intervention under investigation.
Journal Article
Nutraceuticals and innovative food products for healthy living and preventive care
\"This book's research brings a revolution in the field of dietary products and numbers of industries are growing rapidly using these natural products. The book gives us a better understanding of what is an optimal diet, but has allowed food and nutraceutical companies to market products with specific health claims and fortify existing foods\"--Provided by publisher.
Book
Nutraceuticals, antioxidant pigments, and phytochemicals in the leaves of Amaranthus spinosus and Amaranthus viridis weedy species
Six selected weedy
Amaranthus
genotypes (three accessions from each species of
A. viridis
and
A. spinosus
) were evaluated in terms of nutrients, minerals, antioxidant constituents and antioxidant activity for the possibilities of weedy species as a vegetable cultivar in a randomized complete block design with three replications. As leafy vegetable, Weedy
Amaranthus
has remarkable protein, dietary fiber, carbohydrates, Ca, K, Mg, P, S, Fe, Mn, Cu, Zn, Na, Mo, B, chlorophylls, β-cyanins, β-xanthins, betalains, β-carotene, vitamin C, TPC, TFC, and TAC (DPPH and ABTS
+
) compared to any cultivated species. The
A. viridis
genotype WAV7 and
A. spinosus
genotype WAS13 had the highest nutrients, pigments, vitamins, phenolics, flavonoids, and antioxidant. Hence, these two weedy accessions could be used as an antioxidant profile enriched cultivar with high nutritional and antioxidant activity. Pigments, β-carotene, vitamin C, phenolics, and flavonoids had strong antioxidant activity and played a vital role in the antioxidant activity of weedy
Amaranthus
genotypes. Weedy species are an excellent source of phenolics, flavonoids, and antioxidants that have many pharmacological and medicinal effects of their traditional applications and detoxify ROS and offered huge prospects for feeding the antioxidant-deficient community to cope with the hidden hunger and attaining nutritional and antioxidant sufficiency.
Journal Article