Protocol for Pilot Studies: Effectiveness of Bioactive Enriched Foods (BEF) on markers of Metabolic Syndrome

Many naturally-occurring compounds in dietary plants and animal products possess a variety of physiological functions which promote human health and wellbeing, and contribute to better diet-related-disease (DRD) prevention and particularly the Metabolic Syndrome (MS). These compounds, known collectively as bioactives (natural components of foods that possess biological activity in addition to their nutritional value), normally occur at very low concentrations in foods, and their effects on human health are being studied intensively for their possible contribution toward reducing the risk of many DRDs. Identifying bioactives, establishing their mechanisms of actions and health effects are all active areas of scientific inquiry and, through industrial exploitation, potential societal benefit. Scientific understanding of the role and mechanisms of bioactives is fragmented. Research often addresses the theoretical possibility of health improvement effects rather than their real, practical use for everyday diets. Bioactives cannot be considered as discrete chemical compounds and research must focus on bioactive-enriched foods (BEF), if consumer demands for foods delivering appropriate health and wellbeing benefits are to be fulfilled. The general objective of PATHWAY-27, a pan-European interdisciplinary team of 16 life/social scientists and 10 high tech/ food processing SMEs, addresses the exploitation of bioactive compounds as ingredients of foods that, within the common diet, could significantly benefit human health and wellbeing. PATHWAY-27 will evaluate the effectiveness of docosahexaenoic acid (DHA) alone or in combination with two other bioactives, beta-glucan (BG) and anthocyanins (AC), chosen for known/claimed effectiveness in reducing some risk factors of MS. These compounds will be considered as ingredients of BEFs enriching three different widely consumed food matrices (dairy-, bakery-, egg products) and not pure compounds. This will allow us a better understanding of possible synergisms and bioactive matrix interactions. BEFs to be tested in PATHWAY-27 clinical studies will be designed and selected in preceding work packages of this European FP7 project. SMEs will be deeply involved in the elaboration of BEFs. The purpose of pilot clinical studies will be to select, for each of the three food matrices, the BEF delivering the greatest reduction in serum triglycerides (TG) or increase in HDLcholesterol (HDL-C). Three pilot studies will be conducted in three clinical research centres (Max Rubner Institute, Karlsruhe, Germany; University of Leeds, United Kingdom; and Human Nutrition Research Centre of Auvergne, France), each participating centre focusing on a specific food matrix. Each pilot study will be randomized and double blind and aim to identify the most active BEF within a specific food matrix. The BEFs selected after pilot studies will then be tested in the subsequent, larger interventional study, on their ability to modulate a wider range of metabolic outcomes