Guidelines for optimizing design and analysis of clinical studies of nutrient effects

Abstract

Presented here is a system to standardize clinical studies of nutrient effects, using nutrient-specific physiological criteria. These guidelines are based mainly on analysis of the typical sigmoid curve of biological response to nutrients and are intended for design, interpretation, and pooling of studies of nutrient effects. Five rules have been articulated for individual studies of nutrients, and six for systematic reviews and/or meta-analyses.

Keywords: clinical studies; meta-analysis; nutrient effects; sigmoid curve; study design; systematic review.