Human studies for health claims guideline

EFSA General scientific guidance for health claim applications: “Pertinent human studies are an absolute requirement for the scientific substantiation of health claims, and pertinent human efficacy studies are at the top of the hierarchy that informs decisions on substantiation”

Dietary intervention studies must be well designed in order to optimise the quality of the data they provide. A key component of the European Food Safety Authority (EFSA) health claim evaluation process is the provision of robust evidence clearly demonstrating a physiological cause-and-effect relationship that is clinically relevant to human health from at least one well-designed dietary intervention study or randomised controlled trial (RCT). In addition to the food or food component under review being comprehensively characterised, all data must be sufficiently detailed to identify the strength, consistency, specificity, dose-response and biological plausibility of the proposed relationship between food and health.

BACCHUS has developed tools and resources aimed at providing constructive guidance to the food-based SME sector for the development of successful health claim dossiers. “Guidance for the design and implementation of human dietary intervention studies for health claim submissions” has been developed at University College Cork (UCC, IE), and features a comprehensive set of guidelines that consider the major design elements of dietary interventions with a view towards identifying optimal approaches as well as identifying gaps and challenges in developing protocols for dietary intervention studies.

This user-friendly resource was developed for SMEs and others to support the submission of a health claim for foods/food-based bioactives related to cardiovascular health. Guidance is provided at an introductory level and based on experience from the human studies work package within BACCHUS, which has undertaken six randomised placebo-controlled dietary intervention studies investigating the effects of fruit-derived polyphenols and bioactive peptides on cardiovascular disease (CVD) risk using validated biomarkers and established CVD risk factors. Every step in these dietary intervention studies (from concept to dissemination) has been subject to critical evaluation and governance in line with the principles of good clinical practice (GCP) and the EFSA evaluation process for the substantiation of a health claim, which have in turn provided the basis of this guidance document for the design of future food-based dietary interventions.

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If you experience any problems with obtaining the Human studies for health claims guideline, please contact Sian Astley (