Proof of efficacy in controlled human intervention studies with appropriate biomarkers of effect is required to support a claim of benefit to health as a result of consumption of a food, food ingredient or food extract. Six randomised placebo-controlled human intervention studies (phase II randomise clinical trials) will be undertaken to investigate the effect of fruit-derived polyphenols or bioactive peptides on cardiovascular disease risk using validated biomarkers and established risk factors for disease, and will establish a dossier of best practice for translation to future food-based studies with cardiovascular endpoints.

Objectives:

• Undertake six randomised controlled trials (RCT) in human volunteers with food products developed in WP2 to investigate the effects of consuming fruit-derived polyphenol-enriched foods and bioactive peptides on established biomarkers of cardio-metabolic health and cardiovascular disease (CVD) and, where applicable, to distinguish between the relative effects of polyphenolic compounds present at various concentrations in target foods
• Investigate dose-response relationships; these data will be integrated with WP2 to support optimal product development and WP3 to refine estimates of projected distribution of intakes of polyphenols and peptides for maximum health benefit. Biobanked blood and urine samples will undergo further analysis in WP2 (Bioavailability and metabolism) and WP 5 (Mechanisms of action)
• Compile a toolbox of good clinical practice protocols and procedures implemented for each intervention study to support food-based interventions in cardiovascular/metabolic health; this toolbox will be integrated with deliverables from WP1 and disseminated in collaboration with WP7
• Support training through workshops, web-based and published materials to empower SMEs to develop the evidence basis to support valid health claims in collaboration with WP1 and WP7

Workpackage leader: University College Cork, Ireland