CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
- Conditions
- Unstable AnginaCognitive DeclineDiabetes MellitusMetabolic SyndromeMyocardial InfarctionMalignancy
- Interventions
- Behavioral: Low Fat DietBehavioral: Mediterranean Diet
- Registration Number
- NCT00924937
- Lead Sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1002
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Informed Consent
-
Clinical: Unstable coronary disease with documented vessel/myocardial damage
- Acute Myocardial Infarction
- Revascularization
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Age < 20 or > 75 years (or life expectancy lower than 5 years).
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Patients already planned for revascularization.
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Patients submitted to revascularization in the last 6 months
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Grade II-IV Heart failure.
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Left ventricle dysfunction with ejection fraction lower than 35%.
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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.
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Other chronic diseases:
- Psychiatric diseases
- Renal Insufficiency
- Chronic Hepatopathy
- Active Malignancy
- Chronic obstructive pulmonary disease
- Diseases of the digestive tract Endocrine disorders
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Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Fat Diet Low Fat Diet Dietary Intervention with a Low fat diet: \<30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; \<10% saturated fatty acids) Mediterranean Diet Mediterranean Diet Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; \<10% saturated fatty acids).
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis. Seven Years Data from clinical and/or diagnostic tests will be analyzed
Concentration of LDL cholesterol. Seven Years Concentration of LDL cholesterol in blood samples
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL. Seven Years Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c). Seven Years Study of the metabolism of carbohydrates during the trial
Blood pressure. Seven Years Study of blood pressure in response to the study
Incidence of malignancy. Seven Years Appearance of malignancy
Progression of Cognitive Decline. Seven Years Cognitive decline will be evaluated by validated questionnaires
Extended composite of cardiovascular disease progression Seven Years 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.
Extended composite of heart events Seven Years Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Incidence of type 2 Diabetes Mellitus Up to Seven Years Incidence of type 2 Diabetes Mellitus during the study
Anthropometric changes. Metabolic disease Up to Seven Years Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study
Gut Microbiota Up to Seven Years Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
Arrhythmias Up to Seven Years Study of relationship between existing or new Arrhythmias on clinical events
Individual evaluation of all components of the primary outcome. Up to Seven Years Individual apparition of hard cardiovascular events:
* myocardial infarction
* revascularization
* ischemic stroke
* documented peripheral artery disease
* cardiovascular deathGlobal Metabolomics Up to Seven Years Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.
Inflammation and oxidative stress Up to Seven Years Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Specific metabolomics Up to Seven Years Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Gene Expression Up to Seven Years Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
AGEs Up to Seven Years Metabolism of advanced glycation end products.
Mineral metabolism Up to Seven Years Impact of mineral metabolism on atherosclerosis
Echographic markers of cardiac function and clinical outcomes Up to Seven Years Cardiac function studies by Echocardiography at baseline and during the study
Microparticles Up to Seven Years 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
Subgroup analysis Up to Seven Years 27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Trial Locations
- Locations (1)
Reina Sofia University Hospital
🇪🇸Cordoba, Spain