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Definition
The PREDIMED study was a primary prevention trial which tested the long-term effects of the Mediterranean Diet on incident cardiovascular disease in men and women at high cardiovascular risk aged 55-75 y (men) or 60-80 y (women). PREDIMED was a multicenter, nutritional intervention randomized clinical trial carried out in Spain from 2003 to 2011. The study was funded by the official Spanish agency for funding scientific biomedical research, Instituto de Salud Carlos III (Madrid).
We selected participants from >200 primary care facilities affiliated with 11 recruiting sites. All participants were at high risk for CVD, but had no history of prior CVD at enrolment. Criteria for recruitment were the presence of either type 2 diabetes mellitus or 3 or more major risk factors (overweight or obesity, low HDL-cholesterol, high LDL-cholesterol, smoking, hypertension, and family history of early-onset coronary heart disease). Participants were randomized into one of three diets:
1) Mediterranean Diet supplemented with extra-virgin olive oil
2) Mediterranean Diet supplemented with nuts
3) Control diet (advice on a low-fat diet).
Full-time registered dietitians delivered the intervention. Throughout the study, participants attended quarterly individual visits and group sessions in which they were instructed to follow the allocated diets. In the group sessions participants received written material with information on key Mediterranean foods and seasonal shopping lists, menus and specific recipes for a typical week. This material was discussed in detail with the dietitians. Allotments of extra-virgin olive oil (1 L per week, including a minimum of 50 mL/day for participants and the rest for family needs) or mixed nuts (30 g/day: 15 g walnuts, 7.5 g almonds and 7.5 g hazelnuts plus extra allocations for the family) were supplied at no cost to each participant randomly assigned to the Mediterranean Diet groups on a quarterly basis during the group sessions with dietitians. Participants in the control diet group attended similar quarterly sessions with explanations and written material on the low-fat diet and they received non-food gifts. The three diets were energy-unrestricted and no intervention on physical activity was conducted.
1) Mediterranean Diet supplemented with extra-virgin olive oil
2) Mediterranean Diet supplemented with nuts
3) Control diet (advice on a low-fat diet).
Full-time registered dietitians delivered the intervention. Throughout the study, participants attended quarterly individual visits and group sessions in which they were instructed to follow the allocated diets. In the group sessions participants received written material with information on key Mediterranean foods and seasonal shopping lists, menus and specific recipes for a typical week. This material was discussed in detail with the dietitians. Allotments of extra-virgin olive oil (1 L per week, including a minimum of 50 mL/day for participants and the rest for family needs) or mixed nuts (30 g/day: 15 g walnuts, 7.5 g almonds and 7.5 g hazelnuts plus extra allocations for the family) were supplied at no cost to each participant randomly assigned to the Mediterranean Diet groups on a quarterly basis during the group sessions with dietitians. Participants in the control diet group attended similar quarterly sessions with explanations and written material on the low-fat diet and they received non-food gifts. The three diets were energy-unrestricted and no intervention on physical activity was conducted.
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