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PREDIMED PLUS Report Summary

Project ID: 340918
Funded under: FP7-IDEAS-ERC
Country: Spain

Mid-Term Report Summary - PREDIMED PLUS (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 randomised trial. We are running a parallel group, multi-centre, randomised, primary prevention trial (PREDIMED-PLUS) on 6,919 participants, including men aged 55-75 years and women 60-75 years, with a body mass index ≥27 to <40 kg/m2 and meeting at least 3 criteria for the metabolic syndrome in 23 field centres in Spain. The effect of an intensive weight-loss lifestyle intervention based on an energy-restricted traditional Mediterranean diet (“intervention” group) versus a less intensive program using Mediterranean diet, but without any energy restriction or behavioral intervention or physical activity programme (“control” group) will be tested. The final primary end-point is a cardiovascular composite including myocardial infarction, stroke and cardiovascular death.
Baseline characteristics in both groups (intervention, n=3,398; control, n=3,466) were very well balanced. After completing the 6-month follow-up of the first in 3,256 participants (intervention, n=1606; control, n=1650) we found significantly greater weight loss in intervention (-3.52 kg) than in control group (-0.82 kg) and significantly greater reductions in waist circumference (-3.75 vs. -0.92 cm). Significantly stronger reductions were observed in intervention versus control for systolic (-3.5 vs. 0.8 mmHg) and diastolic (-1.6 vs. -0.1 mmHg) blood pressure, fasting blood glucose (-4.7 vs. -1.7 mg/dl) and total cholesterol:HDL ratio (-0.22 vs. -0.06). Changes in the prevalence of the metabolic syndrome (-6% vs. +0.4%) also significantly favored the intervention group. These changes were also observed and even were more dramatic in the subgroups of participants with current follow-up >1 year (n=2,058) and >2 years (n=468).
In conclusion, the energy-restricted Mediterranean diet together with physical activity was superior to the control diet (Mediterranean diet in a low-intensity intervention) in achieving sustained weight loss, a higher reversion rate of the metabolic syndrome than the control group.

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