Assessment of the effects of bioactives on health and wellbeing: clinical protocol design

International audience; PATHWAY-27 will evaluate the effectiveness of docosahexaenoic acid (DHA) alone or in combination with two other bioactives, beta-glucan (BG) and anthocyanins (AC) in reducing some risk factors of Metabolic Syndrome MS. These compounds will be used as ingredients of bioactive-enriched foods (BEF), enriching 3 different widely-consumed food matrices (dairy-, bakery-, egg products) and not as pure compounds. This will allow a better understanding of possible synergisms and bioactive-matrix interactions. BEFs to be tested in clinical studies have been designed, selected and produced by different Pathway’ partners. The aim of this multi-centre, randomized, double- blind, parallel pilot study is to identify the BEF achieving the greatest effect on lipid parameters (reduction in serum triglycerides or increase in HDL-C). The selected BEF will then be tested in a subsequent, larger interventional study. Three different matrices containing DHA, BG and AC given alone or of DHA associated with BG or AC will be tested. 300 men and women at risk for MS will be investigated (either one or two of the following criteria should be met: elevated waist circumference, elevated fasting trigycerides, reduced fasting HDL-C, elevated blood pressure or hypotensive treatment or elevated fasting glucose). MRI, ULE, CRNH will investigate BEFs based on either bakery, dairy or egg products, representing a different food matrix. Each pilot study will be conducted on 100 volunteers for a period of 4 weeks. Participants will be divided in 5 groups receiving BEF enriched with DHA, BG, or AC alone or DHA+BG, or DHA+AC. At baseline and after 4 weeks of intervention, fasting blood samples will be collected for further analysis. Additionally, blood pressure and anthropometric data will be determined. The 3 most effective BEF (one for each matrix) having the most significant impact on end-points selected for this study will be used in a larger randomized, double-blind, placebo-controlled study. The aim will be to understand the mechanisms underlying the effects observed on primary and secondary endpoints related to the consumption of BEF. Omics approaches will be used to examine metabolic changes and potentially identify new markers of effects.