# PREDIMED

Study · id `cardio:predimed` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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

## In plain language

A Spanish trial of a Mediterranean-style diet to lower the chance of heart attacks and strokes in people at high cardiovascular risk who did not yet have cardiovascular disease. 7447 people aged 55 to 80 were assigned to a Mediterranean diet with free extra-virgin olive oil, a Mediterranean diet with free mixed nuts, or advice to eat less fat. The first report (2013) was withdrawn after the authors found that some people had not been randomized. The corrected report found fewer major cardiovascular events with either Mediterranean diet than with the low-fat advice.

## Technical summary

Corrected and republished report (PubMed record 29897866; the original 2013 report was withdrawn by the authors). The abstract gives the trial registration as ISRCTN35739639; no registry record was read, so dates and registry status are not recorded. The 7447 count is the number assigned to a diet; its basis is recorded as unknown because the abstract describes some assignment without randomization. The trial was stopped on a prespecified interim analysis after a median of 4.8 years. Funded by Instituto de Salud Carlos III, the Spanish Ministry of Health and others (abstract). Numbers are on the claim.

## Key facts

- Design: Multicenter trial in Spain of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, and a control diet (advice to reduce dietary fat). The republished report revises effect estimates after protocol deviations in randomization were found.
- Phase: Not reported
- Enrolled: 7447 participants (unknown count; Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts, snapshot `cardio:pubmed-29897866-2026-10-15`, retrieved 2026-10-15)
- Started: Not reported
- Primary completion: Not reported
- Completion: Not reported
- Countries: Spain (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts, snapshot `cardio:pubmed-29897866-2026-10-15`, retrieved 2026-10-15)
- Care setting: A multicenter trial in Spain with 11 study sites; participants attended quarterly educational sessions and received free extra-virgin olive oil, mixed nuts or small nonfood gifts, depending on group (abstract). (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts, snapshot `cardio:pubmed-29897866-2026-10-15`, retrieved 2026-10-15)
- Registry status: Not reported
- Stopped early: The trial stopped early, date not reported. Stopped on the basis of a prespecified interim analysis after a median follow-up of 4.8 years (abstract). The abstract does not give a date. (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts, snapshot `cardio:pubmed-29897866-2026-10-15`, retrieved 2026-10-15)

## Connected pages

- Tests this eating pattern: Mediterranean diet (`cardio:mediterranean-diet`)

## Provenance

Content hash: ec6e9a0b8782433302d64e6290797c35b70e8a0b8ee9b38e2c3fc6794ea1ec65
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15