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Introduction
The PREDIMED trial is the largest primary prevention trial showing that an intervention to promote a Mediterranean diet is beneficial against the incidence of several major chronic diseases in subjects at high cardiovascular risk, particularly when improved adherence to the Mediterranean diet includes increased consumption of extra virgin olive oil and mixed tree nuts.
This study was conducted in Spain with 7,447 participants and showed a significant (approximately 30%) reduction in the combined endpoint of heart attack, stroke and cardiovascular death.
The trial was a primary prevention trial with enrollment limited to individuals who were at risk for developing future heart attacks and strokes but without any prior history of cardiovascular events. Participants were allocated to one of 3 groups: a Mediterranean Diet with supplemental extra virgin olive oil, a Mediterranean Diet with supplemental tree nuts, and a control diet consisting on advice to reduce all types of dietary fat, though actually there was little reduction in fat intake. Median follow-up of trial participants was 4.8 years. This trial shows benefits occurring in patients without prior heart disease, which expands on the Lyon Diet Heart Trial results showing a reduction in heart attack as well as a reduction in total mortality with a Mediterranean Diet in patients who survived an acute myocardial infarction (i.e., it was a secondary prevention trial).
This study was conducted in Spain with 7,447 participants and showed a significant (approximately 30%) reduction in the combined endpoint of heart attack, stroke and cardiovascular death.
The trial was a primary prevention trial with enrollment limited to individuals who were at risk for developing future heart attacks and strokes but without any prior history of cardiovascular events. Participants were allocated to one of 3 groups: a Mediterranean Diet with supplemental extra virgin olive oil, a Mediterranean Diet with supplemental tree nuts, and a control diet consisting on advice to reduce all types of dietary fat, though actually there was little reduction in fat intake. Median follow-up of trial participants was 4.8 years. This trial shows benefits occurring in patients without prior heart disease, which expands on the Lyon Diet Heart Trial results showing a reduction in heart attack as well as a reduction in total mortality with a Mediterranean Diet in patients who survived an acute myocardial infarction (i.e., it was a secondary prevention trial).
PREDIMED PLUS
PREDIMED-PLUS is a multicenter, randomized, primary prevention field trial of cardiovascular disease prevention conducted in community-dwelling men (aged 55 to 75 years) and women (aged 60 to 75 years), with a BMI ranging from ≥ 27 to <40 kg/m2 and meeting three or more criteria for the metabolic syndrome.
Participants are randomized to two groups:
1) A similar intervention to that made in the PREDIMED trial, with a Mediterranean Diet supplemented with extra virgin olive oil and nuts, without calorie restriction or physical activity program or weight loss goals.
2) An intensive intervention with a hypocaloric Mediterranean Diet supplemented with extra virgin olive oil and nuts, adding to the calorie restriction (30%) an intensive lifestyle program with physical activity (walking 45 minutes/day or equivalent) and weight loss goals (8% weight reduction) which includes behavioral therapy.
The primary end-point is a combination of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes).
The total sample size is 6,874 participants randomized to 2 groups. Recruitment of participants began in September 2013 and ended in December 2016. Final results will be available from 2022 onwards.
The PREDIMED-PLUS trial was funded by an Advanced Research Grant of the European Research Council (Principal Investigator: MA Martínez-Gonzalez) and by the Instituto de Salud Carlos III (Coordinator: J. Salas-Salvado).
PREDIMED-PLUS is a multicenter, randomized, primary prevention field trial of cardiovascular disease prevention conducted in community-dwelling men (aged 55 to 75 years) and women (aged 60 to 75 years), with a BMI ranging from ≥ 27 to <40 kg/m2 and meeting three or more criteria for the metabolic syndrome.
Participants are randomized to two groups:
1) A similar intervention to that made in the PREDIMED trial, with a Mediterranean Diet supplemented with extra virgin olive oil and nuts, without calorie restriction or physical activity program or weight loss goals.
2) An intensive intervention with a hypocaloric Mediterranean Diet supplemented with extra virgin olive oil and nuts, adding to the calorie restriction (30%) an intensive lifestyle program with physical activity (walking 45 minutes/day or equivalent) and weight loss goals (8% weight reduction) which includes behavioral therapy.
The primary end-point is a combination of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes).
The total sample size is 6,874 participants randomized to 2 groups. Recruitment of participants began in September 2013 and ended in December 2016. Final results will be available from 2022 onwards.
The PREDIMED-PLUS trial was funded by an Advanced Research Grant of the European Research Council (Principal Investigator: MA Martínez-Gonzalez) and by the Instituto de Salud Carlos III (Coordinator: J. Salas-Salvado).
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