The application of good clinical practice in nutrition research

Abstract

High-quality human studies are indispensable to obtain credible scientific evidence for nutritional effects on the structure and functioning of the human body in health and disease. Although nutrition studies can have specific characteristics in terms of populations, outcomes, designs, methodologies and interventions,1 it is clear that human nutrition research should follow the established basic scientific and operational principles for high-quality design and execution of human studies. These aspects, together with those related to subject protection, form the basis of the ICH Good Clinical Practice (GCP) guidelines.2 Consequently, the GCP principles are relevant and important for human nutrition research. In fact, nearly all articles of the GCP guidelines can be applied to nutrition studies. However, some GCP aspects need a certain level of adaptation to be practically incorporated into nutrition trials. These are discussed in the current paper.