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Long-term effects of an energy-restricted Mediterranean diet on mortality and cardiovascular disease: the PREDIMED PLUS Study


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.

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Campus universitario edificio central
31080 Pamplona

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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.)
EU contribution
No data

Beneficiaries (2)