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ARS Home » Northeast Area » Beltsville, Maryland (BHNRC) » Beltsville Human Nutrition Research Center » Diet, Genomics and Immunology Laboratory » Research » Publications at this Location » Publication #383520
Research Project: Elucidating Phytonutrient Bioavailability, Health Promoting Effects and Mechanisms of Existing/Emerging Foods and Beverages

Location: Diet, Genomics and Immunology Laboratory

Title: Managing Regulatory Requirements in Clinical Nutrition Randomized Controlled Trials: A mini-review and commentary

Author
item Fukagawa, Naomi
item WEAVER, CONNIE - Weaver And Associates Consulting Llc
item LISKA, DEANN - Texas A&M Agrilife
item MATTES, RICHARD - Purdue University
item MATUSZEK, GREGORY - Jean Mayer Human Nutrition Research Center On Aging At Tufts University
item NIEVES, JERI - Columbia University - New York
item SHAPSES, SUE - Rutgers University
item SNETSELAAR, LINDA - University Of Iowa

Submitted to: Annals of Biological Research
Publication Type: Other
Publication Acceptance Date: 4/5/2021
Publication Date: N/A
Citation: N/A

Interpretive Summary: Conducting clinical nutrition RCT carries great responsibility and vulnerability to investigators, participants and institutions. It is of great public health interest to do such research because the nutritional health of a population influences overall health, growth, economic development, and productivity throughout the lifespan of the population. Nutrition scientists involved in the conduct of clinical nutrition randomized, controlled trials (RCTs) are typically trained to apply for approval of the study protocol by an Institutional Review Board (IRB). But little training occurs on a broader scale of good documentation practices and adherence to regulatory requirements, especially for the unique considerations involved in nutrition research (1). Clinical nutrition RCTs can involve controlling by providing the entire diet or a food, beverage, or supplement or giving dietary prescriptions. It can be difficult to distinguish risks associated with normal eating and the actual study intervention. Good documentation and regulation practices are essential for scientific rigor and reproducibility to improve the quality of the evidence base for how diet can influence health. These relationships are used to generate dietary guidelines for the public.

Technical Abstract: Good documentation and regulation practices are essential for scientific rigor and reproducibility to improve the quality of the evidence base that is then used to form conclusions about how diet can influence health parameters which in turn provides the evidence base that generates dietary guidelines for consumers. This commentary addresses the responsibilities and vulnerabilities of investigators and institutions conducting clinical nutrition randomized controlled trials (RCT). The importance of RCT’s on public health is well-accepted, and the importance of training in the responsible conduct of clinical nutrition research is key to the future of establishing an evidence base for diet-related related recommendations.