Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

Connie M Weaver; Naomi K Fukagawa; DeAnn Liska; Richard D Mattes; Gregory Matuszek; Jeri W Nieves; Sue A Shapses; Linda G Snetselaar

doi:10.1093/advances/nmaa118

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Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

Journal article

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Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

Connie M Weaver, Naomi K Fukagawa, DeAnn Liska, Richard D Mattes, Gregory Matuszek, Jeri W Nieves, Sue A Shapses and Linda G Snetselaar

Advances in nutrition (Bethesda, Md.), Vol.12(1), pp.21-45

02/01/2021

DOI: 10.1093/advances/nmaa118

PMCID: PMC7850145

PMID: 33200185

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Abstract

Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled-feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity, and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (institutional review boards, data safety and monitoring boards, US FDA); participant safety; standard operating procedures; training of investigators, staff, and students; and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

Diet

Documentation

Humans

Nutritional Status

Randomized Controlled Trials as Topic

Research Personnel

Details

Title: Subtitle: Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials
Creators: Connie M Weaver - Weaver and Associates Consulting LLC, West Lafayette, IN, USA
Naomi K Fukagawa - USDA-Agricultural Research Service Beltsville Human Nutrition Research Center, Beltsville, MD, USA
DeAnn Liska - Texas A&M AgriLife, College of Agriculture and Life Science, College Station, TX, USA
Richard D Mattes - Department of Nutrition Science, Purdue University, West Lafayette, IN, USA
Gregory Matuszek - Biostatistics and Data Management Core Unit, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA
Jeri W Nieves - Mailman School of Public Health and Institute of Human Nutrition, Columbia University, New York, NY, USA
Sue A Shapses - Department of Medicine, Rutgers RWJ Medical School, New Brunswick, NJ, USA
Linda G Snetselaar - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA
Resource Type: Journal article
Publication Details: Advances in nutrition (Bethesda, Md.), Vol.12(1), pp.21-45
DOI: 10.1093/advances/nmaa118
PMID: 33200185
PMCID: PMC7850145
NLM abbreviation: Adv Nutr
ISSN: 2161-8313
eISSN: 2156-5376
Grant note: UL1 TR002544 / NCATS NIH HHS UL1 TR002014 / NCATS NIH HHS UL1 TR002529 / NCATS NIH HHS
Language: English
Date published: 02/01/2021
Academic Unit: Epidemiology; Fraternal Order of Eagles Diabetes Research Center; Internal Medicine
Record Identifier: 9984215043002771

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