# Mediterranean diet

Intervention · id `cardio:mediterranean-diet` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Browse, organ or system: Heart  
Browse, condition area: Risk and prevention  

## In plain language

An eating pattern studied in Spain in the PREDIMED trial. People at high cardiovascular risk were given a Mediterranean diet plus either free extra-virgin olive oil or free mixed nuts, and a comparison group was advised to cut fat. The corrected report found fewer major cardiovascular events (heart attack, stroke or cardiovascular death) with either Mediterranean diet than with the reduced-fat advice. The authors had withdrawn their first (2013) report after finding that some participants had not been randomized, so the corrected numbers come from analyses that do not assume every participant was randomized.

## Technical summary

MeSH Diet, Mediterranean (D038441) is an exact match. One trial is recorded, in one claim: PREDIMED, a corrected and republished report, stopped on a prespecified interim analysis after a median of 4.8 years. The abstract does not list the components of the diet beyond the supplements, so this record does not describe them. The control diet was advice to reduce dietary fat, so the result compares the Mediterranean diets with that advice and not with unrestricted eating. The effect of the diet outside Spain, or in people who already have cardiovascular disease, is not covered.

## Claims, with the population each applies to

## Context: Adults at high cardiovascular risk without cardiovascular disease, Spain (PREDIMED, republication)

Recipient: Adult; Population: 7447 participants aged 55 to 80 years (57% women) who were at high cardiovascular risk but had no cardiovascular disease at enrollment (abstract).; Care setting: Multicenter trial in Spain with 11 study sites (abstract); participants attended quarterly educational sessions.; Geography: Spain; Life stage: Adults aged 55 to 80 years; Follow-up: Median follow-up of 4.8 years; the trial was stopped on the basis of a prespecified interim analysis.

### In the PREDIMED trial in Spain, 7447 participants (55 to 80 years of age, 57% women) who were at high cardiovascular risk but had no cardiovascular disease at enrollment were assigned 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). 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, a primary end-point event occurred in 288 participants: 96 (3.8%) in the olive oil group, 83 (3.4%) in the nuts group and 109 (4.4%) in the control group. In the intention-to-treat analysis adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% CI 0.53 to 0.91) for the olive oil group and 0.72 (95% CI 0.54 to 0.95) for the nuts group, compared with the control diet. Results were similar after omitting 1588 participants whose study-group assignments were known or suspected to have departed from the protocol. The authors conclude that 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.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: Recipient: Adult; Population: 7447 participants aged 55 to 80 years (57% women) who were at high cardiovascular risk but had no cardiovascular disease at enrollment (abstract).; Care setting: Multicenter trial in Spain with 11 study sites (abstract); participants attended quarterly educational sessions.; Geography: Spain; Life stage: Adults aged 55 to 80 years; Follow-up: Median follow-up of 4.8 years; the trial was stopped on the basis of a prespecified interim analysis.
- Limitations: This is the corrected and republished report. The authors withdrew their 2013 report after they identified protocol deviations (enrollment of household members without randomization, assignment of some participants at 1 of 11 study sites without randomization, and apparent inconsistent use of randomization tables at another site), and report revised estimates from analyses that do not rely exclusively on the assumption that all participants were randomly assigned. The trial was stopped on the basis of a prespecified interim analysis. The control diet was advice to reduce dietary fat, and the diet groups also received quarterly educational sessions and free olive oil or nuts. Participants were at high cardiovascular risk without disease, aged 55 to 80, in Spain. Only the PubMed abstract was read, and the abstract gives the trial registration as ISRCTN35739639 rather than a ClinicalTrials.gov record.
- Last checked: 2026-10-15
- Source problem: a cited source is corrected. Check the sources before relying on this claim.
- Sources:
  1. Supports: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed marks this record as a corrected and republished article and links the withdrawn 2013 report (RepublishedFrom).) <https://doi.org/10.1056/NEJMoa1800389>
     Locator: Abstract, RESULTS, sentences 1 to 3. Retrieved 2026-10-15T13:48:15Z. Source state: Corrected. Snapshot hash: dab726ef13c5c4c2208e057cea07f1a22804759bd806d6186965d45068e0ea19.
     How it applies: Event counts and hazard ratios.
  2. Supports: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed marks this record as a corrected and republished article and links the withdrawn 2013 report (RepublishedFrom).) <https://doi.org/10.1056/NEJMoa1800389>
     Locator: Abstract, CONCLUSIONS, sentence 1. Retrieved 2026-10-15T13:48:15Z. Source state: Corrected. Snapshot hash: dab726ef13c5c4c2208e057cea07f1a22804759bd806d6186965d45068e0ea19.
     How it applies: The authors' conclusion.
  3. Background: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed marks this record as a corrected and republished article and links the withdrawn 2013 report (RepublishedFrom).) <https://doi.org/10.1056/NEJMoa1800389>
     Locator: Abstract, METHODS, sentences 1 to 7. Retrieved 2026-10-15T13:48:15Z. Source state: Corrected. Snapshot hash: dab726ef13c5c4c2208e057cea07f1a22804759bd806d6186965d45068e0ea19.
     How it applies: Design, end point, interim stop and the withdrawal of the 2013 report.

## Connected pages

- PREDIMED, adults aged 55 to 80 at high cardiovascular risk without cardiovascular disease, Spain: fewer major cardiovascular events than reduced-fat advice (corrected report): Preventing heart attack, stroke and heart failure (`cardio:cardiovascular-prevention`) [a claim, not a settled fact; see claim `cardio:claim-predimed-major-cv-events` and its context]
- Filed under this front: Prevention and lifestyle (`cardio:front-prevention-and-lifestyle`)
- Investigated in: PREDIMED (`cardio:predimed`)

## Provenance

Content hash: 921954b669739549216dd0cca0867dd45409259049bea7a5fa1f205b1f489a1e
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15