Cardiovascular Atlas
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PREDIMED

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 The first report (2013) was withdrawn after the authors found that some people had not been randomized.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.

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Overview

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
  • 7,447 participants (unknown count) (Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • ISRCTN ISRCTN35739639
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, retrieved )
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, retrieved )
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, retrieved )

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Corrected and republished report (PubMed record 29897866; the original 2013 report was withdrawn by the authors).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.

Arms

  • Mediterranean diet with extra-virgin olive oil

    Intervention Mediterranean diet

    A Mediterranean diet supplemented with extra-virgin olive oil (abstract).

  • Mediterranean diet with mixed nuts

    Intervention Mediterranean diet

    A Mediterranean diet supplemented with mixed nuts (abstract).

  • Control diet

    Intervention None named

    A control diet: advice to reduce dietary fat (abstract).

Findings

No findings are published for this study.

Record details

Record id
cardio:predimed
Content hash
ec6e9a0b8782433302d64e6290797c35b70e8a0b8ee9b38e2c3fc6794ea1ec65