Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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. opens in new tab.)
No comments:
Post a Comment