title: Primary prevention of cardiovascular disease with a Mediterranean diet.
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.).
authors: Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid, Spain. restruch@clinic.ub.es
authors: Ramón
authors: R
authors: Estruch
authors: Emilio
authors: E
authors: Ros
authors: Jordi
authors: J
authors: Salas-Salvadó
authors: Maria-Isabel
authors: MI
authors: Covas
authors: Dolores
authors: D
authors: Corella
authors: Fernando
authors: F
authors: Arós
authors: Enrique
authors: E
authors: Gómez-Gracia
authors: Valentina
authors: V
authors: Ruiz-Gutiérrez
authors: Miquel
authors: M
authors: Fiol
authors: José
authors: J
authors: Lapetra
authors: Rosa Maria
authors: RM
authors: Lamuela-Raventos
authors: Lluís
authors: L
authors: Serra-Majem
authors: Xavier
authors: X
authors: Pintó
authors: Josep
authors: J
authors: Basora
authors: Miguel Angel
authors: MA
authors: Muñoz
authors: José V
authors: JV
authors: Sorlí
authors: José Alfredo
authors: JA
authors: Martínez
authors: Miguel Angel
authors: MA
authors: Martínez-González
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control*; D018752:Diet, Fat-Restricted; D038441:Diet, Mediterranean; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000453:epidemiology; D009754:Nuts; D000069463:Olive Oil; D010938:Plant Oils; D011322:Primary Prevention; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology
chemical_list: D000069463:Olive Oil; D010938:Plant Oils