Recommendations for Designing, Conducting, and Reporting Feeding Trials in Nutrition Research.

ABSTRACT

Double-blind, placebo-controlled, randomized controlled trials are the gold standard for clinical trials in nutrition science. For trials of whole diets, dietary counseling is advantageous as they offer clinical translatability although can vary in the fidelity of the intended intervention from participant to participant and across studies. Feeding trials, in which most or all food is provided, offer high precision and can provide proof-of-concept evidence that a dietary intervention is efficacious and can also better evaluate the effect of known quantities of foods and nutrients on physiology. However, they come with additional methodological complexities. Feeding trials also call for a variety of unique methodological considerations, not least of which relate to the design and delivery of diets to participants. This review aims to provide a comprehensive summary of recommendations for design and conduct of feeding trials, encompassing domiciled and nondomiciled feeding trials. Several pertinent aspects of trial design and methodology are discussed, including defining the study population to maximize retention, safety, and generalizability of findings, recommendations for design of control interventions and optimizing blinding, and specific considerations for clinical populations. A detailed stepwise process for menu design, development, validation, and delivery are also presented. These recommendations aim to facilitate methodologic consistency and execution of high-quality feeding trials, ultimately facilitating improved understanding of the role of diet in treating disease and the underpinning mechanisms.