N Engl J Med. 2013 Apr 4;368(14):1279-90.
Primary prevention of cardiovascular disease with a Mediterranean diet.
Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F,
Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM,
Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA,
Martínez-González MA; PREDIMED Study Investigators.
Collaborators (233)
Source
Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y
Nutrición, Instituto de Salud Carlos III, Madrid, Spain. restruch@clinic.ub.es
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.).
PMID: 23432189 [PubMed - indexed for MEDLINE]