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Abstract
Observational cohort studies and a secondary prevention trial have shown an inverse
association between adherence to the Mediterranean diet and cardiovascular risk. We
conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular
events.
In a multicenter trial in Spain, we randomly assigned participants who were at high
cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three
diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean
diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat).
Participants received quarterly individual and group educational sessions and, depending
on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small
nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial
infarction, stroke, or death from cardiovascular causes). On the basis of the results
of an interim analysis, the trial was stopped after a median follow-up of 4.8 years.
A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women.
The two Mediterranean-diet groups had good adherence to the intervention, according
to self-reported intake and biomarker analyses. A primary end-point event occurred
in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence
interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned
to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned
to a Mediterranean diet with nuts (83 events), respectively, versus the control group
(109 events). No diet-related adverse effects were reported.
Among persons at high cardiovascular risk, a Mediterranean diet supplemented with
extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events.
(Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com
number, ISRCTN35739639.).