Funded in part by Fundación Mapfre
Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts
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, Fitó M, Gea A, Hernán MA, Martínez-González MA, PREDIMED Study Investigators
The New England journal of medicine · 2433 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
- Intake measured by
- Not stated
Who paid for it
- Funding
- Industry funded
- Government
- Patient-Centered Outcomes Research Institute
- Government
- Generalitat de Catalunya
- Company
- Fundación Mapfre
- Government
- Generalitat Valenciana
- Government
- Departamento de Educación, Gobierno de Navarra
- University or hospital
- Universidad de Navarra
- Government
- Ministerio de Ciencia e Innovación
- University or hospital
- Centro Nacional de Investigaciones Cardiovasculares
- Government
- Junta de Andalucía
- University or hospital
- Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y Nutrición
- Government
- Gobierno de Navarra
- Government
- Instituto de Salud Carlos III
- Government
- European Regional Development Fund
- Government
- Public Health Division of the Department of Health of the Autonomous Government of Catalonia
- Government
- Consejería de Salud de la Junta de Andalucía
- Grants
- European Regional Development Fund (PI11/01647); Instituto de Salud Carlos III (PI 07/0473); European Regional Development Fund (PI07-0954); Ministerio de Ciencia e Innovación (AGL2010-22319-C03); European Regional Development Fund (PI04–2239); Patient-Centered Outcomes Research Institute (ME-1503-28119); Fundación Mapfre (Fundación Mapfre 2010); Generalitat Valenciana (CS2010-AP-111); Instituto de Salud Carlos III (PI1002658); Centro Nacional de Investigaciones Cardiovasculares (06/2007); Instituto de Salud Carlos III (RTIC G03/140); Generalitat Valenciana (GVACOMP2011-151); European Regional Development Fund (CP06/00100); Departamento de Educación, Gobierno de Navarra (P27/2011); Instituto de Salud Carlos III (PI071138); Instituto de Salud Carlos III (RD06/0045); European Regional Development Fund (06/0045); Instituto de Salud Carlos III (PI07/0954); Instituto de Salud Carlos III (PI11/); Instituto de Salud Carlos III (PI07/0240); European Regional Development Fund (PI 07/0473); Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007); European Regional Development Fund (PI 05/2584); Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y Nutrición (PI10/02658); Instituto de Salud Carlos III (PI05/2584); European Regional Development Fund (P11/02505); Ministerio de Ciencia e Innovación (G03/140); Generalitat Valenciana (ACOMP06109); Instituto de Salud Carlos III (RTIC RD06/0045); Instituto de Salud Carlos III (CP 06/00100); European Regional Development Fund (PI10/01407); European Regional Development Fund (PI07/0240); Instituto de Salud Carlos III (G03/140); European Regional Development Fund (RTIC G03/140); European Regional Development Fund ((RD 06/0045); European Regional Development Fund (PI07/1138); Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y Nutrición (G03/140); European Regional Development Fund (PI10/02658); Generalitat Valenciana (CS2011-AP-042); Instituto de Salud Carlos III (PI04/0954); European Regional Development Fund (G03/140); Instituto de Salud Carlos III (PI1001407); Instituto de Salud Carlos III (P11/02505); Instituto de Salud Carlos III (PI11/01647); Ministerio de Ciencia e Innovación (PI10/02658); Ministerio de Ciencia e Innovación (AGL-2009-13906- C02); Generalitat Valenciana (GVACOMP2010-181)
Based on 15 listed funder(s).
Publication
- Published
- 2018-06-13 · N Engl J Med · vol. 378 · issue 25 · pp. 1388–1389
- Publisher
- Massachusetts Medical Society
- Cited
- 3631 citations · more than 100% of similar papers · 295.1× the field average
- Impact
- Top 10% most cited in its field
- References
- 33 works
- Access
- Free to read
- Research areas
- Nutritional Studies and Diet · Nuts composition and effects · Agriculture Sustainability and Environmental Impact
- Keywords
- Olive oil, Mediterranean diet, Disease, Mediterranean climate, Medicine, Primary prevention, Food science, Biology, Internal medicine, Ecology
21 authors
From ES, US
- Ramón EstruchInstituto de Salud Carlos III; Centro de Investigación Biomédica en Red
- Emilio Peña RosCentro de Investigación Biomédica en Red
- Jordi Salas‐SalvadóInstitut de Recerca Biomèdica Catalunya Sud; Centro de Investigación Biomédica en Red; Universitat Rovira i Virgili; Universidad de Navarra
- María‐Isabel CovasCentro de Investigación Biomédica en Red
- Dolores CorellaUniversitat de València; Centro de Investigación Biomédica en Red; Universidad de Navarra
- Fernando ArósCentro de Investigación Biomédica en Red; Universidad de Navarra
Abstract
Background
Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk.
Methods
In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) 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 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 a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned.
Results
A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol.
Conclusions
In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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