Predimed

PREDIMED (Prevención con Dieta Mediterránea (Prevention with Mediterranean Diet)) was a large Spanish primary prevention trial which included 7,447 Spanish participants (55–80 years, 58% women) who were at high risk for cardiovascular disease, but otherwise healthy (initially free of cardiovascular disease). They were randomly assigned to receive interventions with intensive education to one of three diets:

  1. Mediterranean diet supplemented with extra-virgin olive oil.
  2. Mediterranean diet supplemented with nuts.
  3. Control diet encouraging low-fat food items.

The trial was planned for six years, but it was terminated early after a median follow-up of 4.8 years, and demonstrated that both Mediterranean diet groups reached a statistically significant reduction in the rate of the composite cardiovascular primary end-point of myocardial infarction, stroke, or cardiovascular death. This corresponded to an absolute reduction in 3 less cardiovascular events per 1000 patient-years, or a 30% relative risk reduction. Other important observed benefits included a strong reduction in peripheral artery disease, breast cancer, and atrial fibrillation (only associated with the consumption of extra-virgin olive oil).