Mediterranean diet
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 The authors had withdrawn their first (2013) report after finding that some participants had not been randomized, so the corrected numbers come from analyses that do not assume every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.
- Intervention
- In this atlas
Overview
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.
About this intervention
- Type
- Lifestyle
- Mechanism
- A Mediterranean diet supplemented with extra-virgin olive oil or mixed nuts, as given in PREDIMED.
Claims and evidence
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.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
- Included
- Aged 55 to 80 years
- At high cardiovascular risk, with no cardiovascular disease at enrollment
- Excluded
- None stated
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.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Applies to Adult- 7447 participants aged 55 to 80 years (57% women) who were at high cardiovascular risk but had no cardiovascular disease at enrollment (abstract).
- Multicenter trial in Spain with 11 study sites (abstract); participants attended quarterly educational sessions.
- Spain
- Adults aged 55 to 80 years
- Certainty method
- Not assessed
- 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
- Next evidence check due
- Not scheduled
Sources and citations (3)
-
- Locator
- Abstract, RESULTS, sentences 1 to 3
- How it applies
- Event counts and hazard ratios.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
dab726ef13c5c4c2208e057cea07f1a22804759bd806d6186965d45068e0ea19- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
- Locator
- Abstract, CONCLUSIONS, sentence 1
- How it applies
- The authors' conclusion.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
dab726ef13c5c4c2208e057cea07f1a22804759bd806d6186965d45068e0ea19- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
- Locator
- Abstract, METHODS, sentences 1 to 7
- How it applies
- Design, end point, interim stop and the withdrawal of the 2013 report.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
dab726ef13c5c4c2208e057cea07f1a22804759bd806d6186965d45068e0ea19- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
Clinical links
Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.
-
Claim, not a settled fact 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
Applies to Adult- 7447 participants aged 55 to 80 years (57% women) who were at high cardiovascular risk but had no cardiovascular disease at enrollment (abstract).
- Multicenter trial in Spain with 11 study sites (abstract); participants attended quarterly educational sessions.
- Spain
- Adults aged 55 to 80 years
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.Source problem. A cited source is corrected. Check the sources before relying on this claim.
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.
Record details
- Record id
cardio:mediterranean-diet- Content hash
921954b669739549216dd0cca0867dd45409259049bea7a5fa1f205b1f489a1e