Perspective: Guidelines needed for the conduct of human nutrition randomized controlled trials

Authors: WEAVER, CONNIE - Weaver And Associates Consulting Llc; LICHTENSTEIN, ALICE - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; KRIS-ETHERTON, PENNY - Pennsylvania State University

Submitted to: Advances in Nutrition
Publication Type: Review Article
Publication Acceptance Date: 6/17/2020
Publication Date: 11/17/2020
Citation: Weaver, C.M., Lichtenstein, A.H., Kris-Etherton, P.M. 2020. Perspective: Guidelines needed for the conduct of human nutrition randomized controlled trials. Advances in Nutrition. 12(1):1-3. https://doi.org/10.1093/advances/nmaa083.
DOI: https://doi.org/10.1093/advances/nmaa083

Interpretive Summary:

Technical Abstract: Guidelines for designing, conducting, documenting, and reporting human nutrition randomized controlled trials (RCTs) have as yet to be developed and disseminated as reference for investigators, funders, regulators, institutions, assessors, trainees, and others involved in human nutrition research. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements. This Perspective introduces a series of papers that outline core principles for design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Human nutrition RCTs have unique considerations delineated in these papers. Conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care.