Evaluating the effects of food on health in a world of evolving operational challenges

Abstract

In a context of rising interest in food and supplement clinical trials, operational considerations for the set-up and conduct of these research projects remain difficult to address in the absence of a harmonized referential. Food trials tend to be more pragmatic than drug trials which are usually more elucidatory. However, comparing them is difficult because the objectives they serve are different. Food trials are usually conducted to evaluate the effect of food products on the prevention or mitigation of symptoms, not the treatment or cure of a condition. In this article we explain these main differences and discuss several key operational and regulatory aspects to consider when dealing with clinical research evaluating the effect of food products on health-related biomedical or behavioral outcomes. Keywords: Nutrition research, Clinical operations, Regulation, Good clinical practices