Objective The impact of weight loss on cardiovascular disease risk within the frame of the Mediterranean dietary pattern has not yet been tested using a sufficiently large randomized trial (Malik, Hu, 2007). We propose to run a parallel group, multi-center, randomized, primary prevention trial (PREDIMED PLUS) on men aged 55-75 years and women 65-75 years, with a body mass index ≥27 to <40 kg/m2 and meeting at least 3 criteria for the metabolic syndrome. The objective of the present research is to address the cardiovascular effect of an intensive weight-loss lifestyle intervention based on an energy-restricted traditional Mediterranean diet in comparison with a less intensive program using Mediterranean diet, but with no energy restriction, behavioural intervention or physical activity programme. The end-point is a composite of major hard clinical cardiovascular events. We hypothesize that an intensive weight-loss lifestyle intervention, including physical activity, based on the traditional Mediterranean food pattern is a sustainable long-term approach for weight reduction among overweight/obese adults and that the achieved lifestyle changes will exert beneficial effects on cardiovascular disease incidence, according to our experience (Estruch R et al., 2012) and research by other investigators (Shai et al., 2008). The rationale for the proposed investigation is that it can provide a new, affordable, and sustainable approach to reduce excess cardiovascular morbidity and mortality among overweight/obese adults, beyond what was already observed in the PREDIMED I trial. Fields of science social sciencessociologydemographymortalityengineering and technologymaterials engineeringcompositesmedical and health scienceshealth sciencesnutritionmedical and health sciencesclinical medicinecardiologycardiovascular diseases Programme(s) FP7-IDEAS-ERC - Specific programme: "Ideas" implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) Topic(s) ERC-AG-LS7 - ERC Advanced Grant - Diagnostic tools, therapies and public health Call for proposal ERC-2013-ADG See other projects for this call Funding Scheme ERC-AG - ERC Advanced Grant Host institution UNIVERSIDAD DE NAVARRA EU contribution € 1 496 754,47 Address CAMPUS UNIVERSITARIO EDIFICIO CENTRAL 31080 Pamplona Spain See on map Region Noreste Comunidad Foral de Navarra Navarra Activity type Higher or Secondary Education Establishments Principal investigator Miguel ángel Martínez González (Prof.) Administrative Contact Fco. Javier Irigoyen Barrio (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Beneficiaries (2) Sort alphabetically Sort by EU Contribution Expand all Collapse all UNIVERSIDAD DE NAVARRA Spain EU contribution € 1 496 754,47 Address CAMPUS UNIVERSITARIO EDIFICIO CENTRAL 31080 Pamplona See on map Region Noreste Comunidad Foral de Navarra Navarra Activity type Higher or Secondary Education Establishments Principal investigator Miguel ángel Martínez González (Prof.) Administrative Contact Fco. Javier Irigoyen Barrio (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CONSORCIO CENTRO DE INVESTIGACION BIOMEDICA EN RED M.P. Spain EU contribution € 582 215,15 Address CALLE MONFORTE DE LEMOS 5 28029 Madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Research Organisations Administrative Contact Manuel Sanchez (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data