Clinical trial · Interventional
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
NCT00924937CI-TRIAL-00052085CORDIOPREVcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Decline | — | UNRESOLVED | — |
| Diabetes Mellitus | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Metabolic Syndrome | — | UNRESOLVED | — |
| Myocardial Infarction | — | UNRESOLVED | — |
| Unstable Angina | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Fat Diet | Behavioral | — | UNRESOLVED |
| Mediterranean Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low Fat Diet
- description
- Dietary Intervention with a Low fat diet: \<30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; \<10% saturated fatty acids)
- interventionNames
- Behavioral: Low Fat Diet
- type
- EXPERIMENTAL
- label
- Mediterranean Diet
- description
- Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; \<10% saturated fatty acids).
- interventionNames
- Behavioral: Mediterranean Diet
Primary outcomes (1)
- measure
- Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent * Clinical: Unstable coronary disease with documented vessel/myocardial damage * Acute Myocardial Infarction * Revascularization Exclusion Criteria: * Age \< 20 or \> 75 years (or life expectancy lower than 5 years). * Patients already planned for revascularization. * Patients submitted to revascularization in the last 6 months * Grade II-IV Heart failure. * Left ventricle dysfunction with ejection fraction lower than 35%. * Patients unable to follow a protocol. * Patients with severe uncontrol of Diabetes Mellitus, or those with Renal Insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of Diabetes mellitus. * Other chronic diseases: * Psychiatric diseases * Renal Insufficiency * Chronic Hepatopathy * Active Malignancy * Chronic obstructive pulmonary disease * Diseases of the digestive tract Endocrine disorders * Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).
References
Publications (38)
- DERIVEDGaraulet M, Romero-Cabrera JL, Alcala-Diaz JF, Arenas-de Larriva AP, Torres-Pena D, Rodriguez-Cantalejo F, Sotos-Prieto M, Kales SN, Delgado-Lista J, Perez-Martinez P, Garcia-Rios A, Miranda JL. Short siesta habit and cardiometabolic health: A 7-year follow-up in coronary heart disease patients from the CORDIOPREV study. Metabolism. 2026 Aug 4:156724. doi: 10.1016/j.metabol.2026.156724. Online ahead of print. PMID 42551629
- DERIVEDArenas-Montes J, Garcia-Fernandez H, Alcala-Diaz JF, Boughanem H, Allais A, Gutierrez-Mariscal FM, Arenas-de Larriva AP, Ojeda-Rodriguez A, Malagon MM, Priego-Capote F, Delgado-Lista J, Perez-Martinez P, Camargo A, Lopez-Miranda J. High postprandial endotoxemia is associated with recurrence of cardiovascular events in patients with coronary heart disease: from the CORDIOPREV randomized clinical trial. Am J Clin Nutr. 2026 Jul;124(1):101323. doi: 10.1016/j.ajcnut.2026.101323. Epub 2026 Jun 8. PMID 42386249
- DERIVEDDelgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Arenas Larriva AP, Fuentes F, Garcia-Rios A, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Katsiki N, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Incidence of major adverse cardiovascular events decreases with greater adherence to both Mediterranean and low-fat dietary patterns in secondary prevention patients: a randomized controlled trial. Eur J Intern Med. 2026 May;147:106733. doi: 10.1016/j.ejim.2026.106733. Epub 2026 Jan 28. PMID 41611577
- DERIVEDGarcia-Rios A, Romero-Cabrera JL, Alcala-Diaz JF, Quintana-Navarro GM, Martin-Piedra L, Arenas-de Larriva AP, Torres-Pena JD, Rodriguez-Cantalejo F, Kales SN, Ordovas JM, Perez-Martinez P, Delgado-Lista J, Lopez-Miranda J. Long sleep duration pattern is associated with increased cardiovascular recurrence: Effect of long-term Mediterranean diet from the CORDIOPREV study. J Intern Med. 2025 Sep;298(3):237-250. doi: 10.1111/joim.20119. Epub 2025 Jul 17. PMID 40677148
- DERIVEDBoughanem H, Gutierrez-Mariscal FM, Arenas-de Larriva AP, Torres-Pena JD, Romero-Cabrera JL, Rangel-Zuniga OA, Garcia-Fernandez H, Podadera-Herreros A, Rodriguez-Cantalejo F, Soehnlein O, Macias-Gonzalez M, Tinahones FJ, Yubero Serrano EM, Perez-Martinez P, Delgado-Lista J, Lopez-Miranda J. Effect of long-term Mediterranean versus low-fat diet on neutrophil count, and type 2 diabetes mellitus remission in patients with coronary heart disease: results from the CORDIOPREV study. Nutr Diabetes. 2025 Mar 27;15(1):11. doi: 10.1038/s41387-025-00360-3.