Myocardial InfarctionCORDIOPREVNCT00924937
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
A study testing Mediterranean Diet and Low Fat Diet in people with Myocardial Infarction and Unstable Angina, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Myocardial Infarction, Unstable Angina, Malignancy
- What is being tested?
- Mediterranean Diet and Low Fat Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2009to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- Clinical: Unstable coronary disease with documented vessel/myocardial damage
- Acute Myocardial Infarction
- Revascularization
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
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.
Read the detailed description
Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).
Primary Objective:
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).
Secondary Objectives:
Those related in the Outcome Measures section of this webpage
- Conditions
- Myocardial Infarction, Unstable Angina, Malignancy, Cognitive Decline, Diabetes Mellitus, Metabolic Syndrome
- Being tested
- Mediterranean Diet, Low Fat Diet
- Keywords
- Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet
- Medical subject headings
- Myocardial Infarction, Angina, Unstable, Neoplasms, Cognitive Dysfunction, Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
Low Fat DietBehavioural
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
| Study group | Role | What they receive |
|---|---|---|
| Low Fat Diet | Active comparator | Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids) Receives: Behavioral: Low Fat Diet |
| Mediterranean Diet | Experimental | Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids). Receives: Behavioral: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Seven Years
Secondary outcomes (23)
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Data from clinical and/or diagnostic tests will be analyzed
Measured: Seven Years
Concentration of LDL cholesterol.
Concentration of LDL cholesterol in blood samples
Measured: Seven Years
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
Measured: Seven Years
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
Study of the metabolism of carbohydrates during the trial
Measured: Seven Years
Blood pressure.
Study of blood pressure in response to the study
Measured: Seven Years
Incidence of malignancy.
Appearance of malignancy
Measured: Seven Years
Progression of Cognitive Decline.
Cognitive decline will be evaluated by validated questionnaires
Measured: Seven Years
Extended composite of cardiovascular disease progression
Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.
Measured: Seven Years
Extended composite of heart events
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Measured: Seven Years
Incidence of type 2 Diabetes Mellitus
Incidence of type 2 Diabetes Mellitus during the study
Measured: Up to Seven Years
Anthropometric changes. Metabolic disease
Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study
Measured: Up to Seven Years
Gut Microbiota
Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
Measured: Up to Seven Years
Arrhythmias
Study of relationship between existing or new Arrhythmias on clinical events
Measured: Up to Seven Years
Individual evaluation of all components of the primary outcome.
Individual apparition of hard cardiovascular events:
- myocardial infarction
- revascularization
- ischemic stroke
- documented peripheral artery disease
- cardiovascular death
Measured: Up to Seven Years
Global Metabolomics
Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.
Measured: Up to Seven Years
Specific metabolomics
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Measured: Up to Seven Years
Gene Expression
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
Measured: Up to Seven Years
Inflammation and oxidative stress
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Measured: Up to Seven Years
AGEs
Metabolism of advanced glycation end products.
Measured: Up to Seven Years
Mineral metabolism
Impact of mineral metabolism on atherosclerosis
Measured: Up to Seven Years
Echographic markers of cardiac function and clinical outcomes
Cardiac function studies by Echocardiography at baseline and during the study
Measured: Up to Seven Years
Microparticles
Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry
Measured: Up to Seven Years
Subgroup analysis
- Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Measured: Up to Seven Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2018
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Francisco Perez Jimenez, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- Francisco Perez-Jimenez, MD,PhD, Principal investigator, Reina Sofia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924937
- Sponsor's protocol ID
- CORDIOPREV
- Acronym
- CORDIOPREV
- Status last verified
- May 2021
- First submitted
- 18 Jun 2009
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Garaulet 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.
PubMed 42551629Arenas-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.
PubMed 42386249Delgado-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.
PubMed 41611577Garcia-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.
PubMed 40677148Boughanem 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.
PubMed 40148287Gutierrez-Mariscal FM, Lopez-Moreno A, Torres-Pena JD, Gomez-Luna P, Arenas-de Larriva AP, Romero-Cabrera JL, Luque RM, Uribarri J, Perez-Martinez P, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Modulation of circulating levels of advanced glycation end products and its impact on intima-media thickness of both common carotid arteries: CORDIOPREV randomised controlled trial. Cardiovasc Diabetol. 2024 Oct 14;23(1):361. doi: 10.1186/s12933-024-02451-4.
PubMed 39402581Podadera-Herreros A, Arenas-de Larriva AP, Gutierrez-Mariscal FM, Alcala-Diaz JF, Ojeda-Rodriguez A, Rodriguez-Cantalejo F, Cardelo MP, Rodriguez-Cano D, Torres-Pena JD, Luque RM, Ordovas JM, Perez-Martinez P, Delgado-Lista J, Lopez-Miranda J, Yubero-Serrano EM. Mediterranean diet as a strategy for preserving kidney function in patients with coronary heart disease with type 2 diabetes and obesity: a secondary analysis of CORDIOPREV randomized controlled trial. Nutr Diabetes. 2024 May 16;14(1):27. doi: 10.1038/s41387-024-00285-3.
PubMed 38755195Ojeda-Rodriguez A, Rangel-Zuniga OA, Arenas-de Larriva AP, Gutierrez-Mariscal FM, Torres-Pena JD, Romero-Cabrera JL, Podadera-Herreros A, Garcia-Fernandez H, Porras-Perez E, Luque RM, Kales SN, Perez-Martinez P, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Telomere length as biomarker of nutritional therapy for prevention of type 2 diabetes mellitus development in patients with coronary heart disease: CORDIOPREV randomised controlled trial. Cardiovasc Diabetol. 2024 Mar 16;23(1):98. doi: 10.1186/s12933-024-02175-5.
PubMed 38493287Garcia-Fernandez H, Arenas-de Larriva AP, Lopez-Moreno J, Gutierrez-Mariscal FM, Romero-Cabrera JL, Molina-Abril H, Torres-Pena JD, Rodriguez-Cano D, Malagon MM, Ordovas JM, Delgado-Lista J, Perez-Martinez P, Lopez-Miranda J, Camargo A. Sex-specific differences in intestinal microbiota associated with cardiovascular diseases. Biol Sex Differ. 2024 Jan 19;15(1):7. doi: 10.1186/s13293-024-00582-7.
PubMed 38243297Rivas-Garcia L, Quintana-Navarro GM, Torres-Pena JD, Arenas-de Larriva AP, Alcala-Diaz JF, Yubero-Serrano EM, Perez Caballero AI, Ortiz-Morales AM, Rangel-Zuniga OA, Lopez-Moreno A, Ordovas JM, Perez-Martinez P, Lopez-Miranda J, Delgado-Lista J. Dietary antioxidant intake reduces carotid intima-media thickness in coronary heart disease patients: From the CORDIOPREV study. Free Radic Biol Med. 2024 Jan;210:221-229. doi: 10.1016/j.freeradbiomed.2023.11.026. Epub 2023 Nov 29.
PubMed 38036071Villasanta-Gonzalez A, Mora-Ortiz M, Alcala-Diaz JF, Rivas-Garcia L, Torres-Pena JD, Lopez-Bascon A, Calderon-Santiago M, Arenas-Larriva AP, Priego-Capote F, Malagon MM, Eichelmann F, Perez-Martinez P, Delgado-Lista J, Schulze MB, Camargo A, Lopez-Miranda J. Plasma lipidic fingerprint associated with type 2 diabetes in patients with coronary heart disease: CORDIOPREV study. Cardiovasc Diabetol. 2023 Aug 3;22(1):199. doi: 10.1186/s12933-023-01933-1.
PubMed 37537576Gutierrez-Mariscal FM, Alcala-Diaz JF, Quintana-Navarro GM, de la Cruz-Ares S, Torres-Pena JD, Cardelo MP, Arenas-Larriva AP, Malagon MM, Romero-Cabrera JL, Ordovas JM, Perez-Martinez P, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Changes in quantity plant-based protein intake on type 2 diabetes remission in coronary heart disease patients: from the CORDIOPREV study. Eur J Nutr. 2023 Jun;62(4):1903-1913. doi: 10.1007/s00394-022-03080-x. Epub 2023 Mar 4.
PubMed 36869909Mora-Ortiz M, Alcala-Diaz JF, Rangel-Zuniga OA, Arenas-de Larriva AP, Abollo-Jimenez F, Luque-Cordoba D, Priego-Capote F, Malagon MM, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Camargo A, Lopez-Miranda J. Metabolomics analysis of type 2 diabetes remission identifies 12 metabolites with predictive capacity: a CORDIOPREV clinical trial study. BMC Med. 2022 Oct 27;20(1):373. doi: 10.1186/s12916-022-02566-z.
PubMed 36289459Yubero-Serrano EM, Gutierrez-Mariscal FM, Gomez-Luna P, Alcala-Diaz JF, Perez-Martinez P, Lopez-Miranda J. Dietary modulation of advanced glycation end products metabolism on carotid intima-media thickness in type 2 diabetes patients: From the CORDIOPREV study. Clin Investig Arterioscler. 2023 May-Jun;35(3):105-114. doi: 10.1016/j.arteri.2022.08.004. Epub 2022 Sep 29. English, Spanish.
PubMed 36184301Delgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Fuentes F, Garcia-Rios A, Ortiz-Morales AM, Gonzalez-Requero AI, Perez-Caballero AI, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Lopez-Segura F, Badimon L, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.
PubMed 35525255
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
- ClinicalTrials.gov ID
- NCT00924937
- Acronym / sponsor ID
- CORDIOPREV / CORDIOPREV
- Conditions
- Myocardial Infarction, Unstable Angina, Malignancy, Cognitive Decline, Diabetes Mellitus, Metabolic Syndrome
- Keywords
- Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- Nov 2009 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).
Primary Objective:
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).
Secondary Objectives:
Those related in the Outcome Measures section of this webpage
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fat Diet | Active comparator | Behavioral: Low Fat DietDietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids) |
| Mediterranean Diet | Experimental | Behavioral: Mediterranean DietDietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent
- Clinical: Unstable coronary disease with documented vessel/myocardial damage
Key exclusion criteria (15 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietMediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT). | Behavioural | Mediterranean Diet |
| Low Fat DietLow fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT) | Behavioural | Low Fat Diet |
Primary outcome
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.
Time frame: Seven Years
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.
23 secondary outcomes
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Time frame: Seven Years
Concentration of LDL cholesterol.
Time frame: Seven Years
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
Time frame: Seven Years
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
Time frame: Seven Years
Blood pressure.
Time frame: Seven Years
Incidence of malignancy.
Time frame: Seven Years
Progression of Cognitive Decline.
Time frame: Seven Years
Extended composite of cardiovascular disease progression
Time frame: Seven Years
Extended composite of heart events
Time frame: Seven Years
Incidence of type 2 Diabetes Mellitus
Time frame: Up to Seven Years
Anthropometric changes. Metabolic disease
Time frame: Up to Seven Years
Gut Microbiota
Time frame: Up to Seven Years
Arrhythmias
Time frame: Up to Seven Years
Individual evaluation of all components of the primary outcome.
Time frame: Up to Seven Years
Global Metabolomics
Time frame: Up to Seven Years
Specific metabolomics
Time frame: Up to Seven Years
Gene Expression
Time frame: Up to Seven Years
Inflammation and oxidative stress
Time frame: Up to Seven Years
AGEs
Time frame: Up to Seven Years
Mineral metabolism
Time frame: Up to Seven Years
Echographic markers of cardiac function and clinical outcomes
Time frame: Up to Seven Years
Microparticles
Time frame: Up to Seven Years
Subgroup analysis
Time frame: Up to Seven Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 42551629Garaulet 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.
- Derived from this study: PubMed 42386249Arenas-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.
- Derived from this study: PubMed 41611577Delgado-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.
- Derived from this study: PubMed 40677148Garcia-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.
- Derived from this study: PubMed 40148287Boughanem 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.
- Derived from this study: PubMed 39402581Gutierrez-Mariscal FM, Lopez-Moreno A, Torres-Pena JD, Gomez-Luna P, Arenas-de Larriva AP, Romero-Cabrera JL, Luque RM, Uribarri J, Perez-Martinez P, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Modulation of circulating levels of advanced glycation end products and its impact on intima-media thickness of both common carotid arteries: CORDIOPREV randomised controlled trial. Cardiovasc Diabetol. 2024 Oct 14;23(1):361. doi: 10.1186/s12933-024-02451-4.
- Derived from this study: PubMed 38755195Podadera-Herreros A, Arenas-de Larriva AP, Gutierrez-Mariscal FM, Alcala-Diaz JF, Ojeda-Rodriguez A, Rodriguez-Cantalejo F, Cardelo MP, Rodriguez-Cano D, Torres-Pena JD, Luque RM, Ordovas JM, Perez-Martinez P, Delgado-Lista J, Lopez-Miranda J, Yubero-Serrano EM. Mediterranean diet as a strategy for preserving kidney function in patients with coronary heart disease with type 2 diabetes and obesity: a secondary analysis of CORDIOPREV randomized controlled trial. Nutr Diabetes. 2024 May 16;14(1):27. doi: 10.1038/s41387-024-00285-3.
- Derived from this study: PubMed 38493287Ojeda-Rodriguez A, Rangel-Zuniga OA, Arenas-de Larriva AP, Gutierrez-Mariscal FM, Torres-Pena JD, Romero-Cabrera JL, Podadera-Herreros A, Garcia-Fernandez H, Porras-Perez E, Luque RM, Kales SN, Perez-Martinez P, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Telomere length as biomarker of nutritional therapy for prevention of type 2 diabetes mellitus development in patients with coronary heart disease: CORDIOPREV randomised controlled trial. Cardiovasc Diabetol. 2024 Mar 16;23(1):98. doi: 10.1186/s12933-024-02175-5.
- Derived from this study: PubMed 38243297Garcia-Fernandez H, Arenas-de Larriva AP, Lopez-Moreno J, Gutierrez-Mariscal FM, Romero-Cabrera JL, Molina-Abril H, Torres-Pena JD, Rodriguez-Cano D, Malagon MM, Ordovas JM, Delgado-Lista J, Perez-Martinez P, Lopez-Miranda J, Camargo A. Sex-specific differences in intestinal microbiota associated with cardiovascular diseases. Biol Sex Differ. 2024 Jan 19;15(1):7. doi: 10.1186/s13293-024-00582-7.
- Derived from this study: PubMed 38036071Rivas-Garcia L, Quintana-Navarro GM, Torres-Pena JD, Arenas-de Larriva AP, Alcala-Diaz JF, Yubero-Serrano EM, Perez Caballero AI, Ortiz-Morales AM, Rangel-Zuniga OA, Lopez-Moreno A, Ordovas JM, Perez-Martinez P, Lopez-Miranda J, Delgado-Lista J. Dietary antioxidant intake reduces carotid intima-media thickness in coronary heart disease patients: From the CORDIOPREV study. Free Radic Biol Med. 2024 Jan;210:221-229. doi: 10.1016/j.freeradbiomed.2023.11.026. Epub 2023 Nov 29.
- Derived from this study: PubMed 37537576Villasanta-Gonzalez A, Mora-Ortiz M, Alcala-Diaz JF, Rivas-Garcia L, Torres-Pena JD, Lopez-Bascon A, Calderon-Santiago M, Arenas-Larriva AP, Priego-Capote F, Malagon MM, Eichelmann F, Perez-Martinez P, Delgado-Lista J, Schulze MB, Camargo A, Lopez-Miranda J. Plasma lipidic fingerprint associated with type 2 diabetes in patients with coronary heart disease: CORDIOPREV study. Cardiovasc Diabetol. 2023 Aug 3;22(1):199. doi: 10.1186/s12933-023-01933-1.
- Derived from this study: PubMed 36869909Gutierrez-Mariscal FM, Alcala-Diaz JF, Quintana-Navarro GM, de la Cruz-Ares S, Torres-Pena JD, Cardelo MP, Arenas-Larriva AP, Malagon MM, Romero-Cabrera JL, Ordovas JM, Perez-Martinez P, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Changes in quantity plant-based protein intake on type 2 diabetes remission in coronary heart disease patients: from the CORDIOPREV study. Eur J Nutr. 2023 Jun;62(4):1903-1913. doi: 10.1007/s00394-022-03080-x. Epub 2023 Mar 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Perez-Jimenez, MD,PhD principal investigator
Reina Sofia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet and Low Fat Diet in people with Myocardial Infarction and Unstable Angina, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Seven Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924937, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.