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

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.
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Principal Investigator

Miguel ángel Martínez González (Prof.)

Host institution

UNIVERSIDAD DE NAVARRA

Address

Campus Universitario Edificio Central
31080 Pamplona

Spain

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 496 754,47

Principal Investigator

Miguel ángel Martínez González (Prof.)

Administrative Contact

Fco. Javier Irigoyen Barrio (Mr.)

Beneficiaries (2)

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UNIVERSIDAD DE NAVARRA

Spain

EU Contribution

€ 1 496 754,47

CONSORCIO CENTRO DE INVESTIGACION BIOMEDICA EN RED M.P.

Spain

EU Contribution

€ 582 215,15

Project information

Grant agreement ID: 340918

Status

Closed project

  • Start date

    1 May 2014

  • End date

    30 April 2019

Funded under:

FP7-IDEAS-ERC

  • Overall budget:

    € 2 078 969,62

  • EU contribution

    € 2 078 969,62

Hosted by:

UNIVERSIDAD DE NAVARRA

Spain