The Challenge of Reproducibility and Accuracy in Nutrition Research: Resources and Pitfalls

Sorkin, Barbara C.; Kuszak, Adam; Williamson, John S.; Hopp, D. Craig; Betz, Joseph M.

doi:10.3945/an.115.010595

Cited by 33 publications

(26 citation statements)

References 37 publications

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“…Recent attention has also emphasized the challenge of reproducibility and accuracy in human nutrition research [ 125 ]. As noted above, more complete compositional profiles of dates are needed rather than simply recognizing the total amount of GAEs, a gross index of flavonoid content.…”

Section: Future Considerationsmentioning

confidence: 99%

Date Palm Fruit (Phoenix dactylifera): Effects on Vascular Health and Future Research Directions

Al-Dashti

Holt

Keen

et al. 2021

IJMS

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Cardiovascular disease is a leading cause of death globally, presenting an immense public and economic burden. Studies on cardioprotective foods and their bioactive components are needed to address both personal and public health needs. Date fruit is rich in polyphenols, particularly flavonoids, certain micronutrients, and dietary fiber, which can impact vascular health, and have the potential to attenuate vascular disease in humans. Data from in vitro and animal studies report that consumption of date fruit or extracts can modulate select markers of vascular health, particularly plasma lipid levels including triglycerides and cholesterol, indices of oxidative stress and inflammation, but human data is scant. More investigation is needed to better characterize date polyphenols and unique bioactive compounds or fractions, establish safe and effective levels of intake, and delineate underlying mechanisms of action. Implementing scientific rigor in clinical trials and assessment of functional markers of vascular disease, such as flow-mediated dilation and peripheral arterial tonometry, along with gut microbiome profiles would provide useful information with respect to human health. Emerging data supports the notion that intake of date fruit and extracts can be a useful component of a healthy lifestyle for those seeking beneficial effects on vascular health.

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Section: Future Considerationsmentioning

confidence: 99%

Date Palm Fruit (Phoenix dactylifera): Effects on Vascular Health and Future Research Directions

Al-Dashti

Holt

Keen

et al. 2021

IJMS

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“…[12][13][14] The often incomplete and/or conflicting information on mechanisms of action, appropriate uses, and expected health effects poses challenges for formulating hypotheses and designing CT. [12][13][14] The often incomplete and/or conflicting information on mechanisms of action, appropriate uses, and expected health effects poses challenges for formulating hypotheses and designing CT.…”

Section: Challenges To Be Addressedmentioning

confidence: 99%

Improving natural product research translation: From source to clinical trial

et al. 2019

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While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a Septe mber, 2018 trans disci plina ry workshop. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research. K E Y W O R D S clinical predictive validity, dietary supplements, model systems, rigor and replicability, value of information | 43 SORKIN et al.still provide invaluable guidance, the results of such trials are often met with concerns that different design choiceswhether of product, dose, timing, participant eligibility criteria, outcomes, etc.-might have yielded a substantially different result. Each interventional trial represents a substantial investment, with well-powered Phase III CTs typically consuming more than $10 million and many person-years. 9,10 Additionally, as time and funds are limited, and participant pools may also be constrained, a decision to invest in a CT often precludes pursuing other research questions, 11 which may provide more useful public health-relevant knowledge than an RCT with an insufficient evidence base.

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“…However, many products list herbals and botanicals as part of proprietary blends, which is permissible under U.S. law. To complicate matters even further, biological variability is known to exist in the bioactive components of natural products that is described in great detail elsewhere (Sorkin et al 2016).…”

Section: Limitations Of Existing Regulations and Resourcesmentioning

confidence: 99%

Current regulatory guidelines and resources to support research of dietary supplements in the United States

Bailey

2018

Critical Reviews in Food Science and Nutrition

104

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The U.S. Dietary Supplement Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the Food and Drug Administration (FDA). DSHEA outlined the legal definition, labeling requirements, and process for adverse event reporting for dietary supplements. FDA also issued formal guidance on current Good Manufacturing Practice to ensure that processes for preparation, packaging, labeling, and storage of supplements and ingredients are documented and meet specifications to ensure purity, composition, and strength. However, efficacy of dietary supplements is not required under U.S. law. Despite regulations to improve the marketplace, many challenges remain; as a result, the quality and safety of products available can be highly variable, especially for botanical and herbal products. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety. This review will highlight the existing American regulatory framework for dietary supplements and will describe the remaining regulatory barriers to ensuring that safe and high-quality dietary supplements are offered in the marketplace.

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The Challenge of Reproducibility and Accuracy in Nutrition Research: Resources and Pitfalls

Cited by 33 publications

References 37 publications

Date Palm Fruit (Phoenix dactylifera): Effects on Vascular Health and Future Research Directions

Date Palm Fruit (Phoenix dactylifera): Effects on Vascular Health and Future Research Directions

Improving natural product research translation: From source to clinical trial

Current regulatory guidelines and resources to support research of dietary supplements in the United States

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