CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Overview

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.

Full Title of Study: “Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2018

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

Interventions

  • Behavioral: Mediterranean Diet
    • Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
  • Behavioral: Low Fat Diet
    • Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)

Arms, Groups and Cohorts

  • Active Comparator: 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)
  • Experimental: Mediterranean Diet
    • Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
    • Time Frame: Seven Years
    • Data from clinical and/or diagnostic tests will be analyzed
  • Concentration of LDL cholesterol.
    • Time Frame: Seven Years
    • Concentration of LDL cholesterol in blood samples
  • Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
    • Time Frame: 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).
    • Time Frame: Seven Years
    • Study of the metabolism of carbohydrates during the trial
  • Blood pressure.
    • Time Frame: Seven Years
    • Study of blood pressure in response to the study
  • Incidence of malignancy.
    • Time Frame: Seven Years
    • Appearance of malignancy
  • Progression of Cognitive Decline.
    • Time Frame: Seven Years
    • Cognitive decline will be evaluated by validated questionnaires
  • Extended composite of cardiovascular disease progression
    • Time Frame: 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
    • Time Frame: Seven Years
    • Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
  • Incidence of type 2 Diabetes Mellitus
    • Time Frame: Up to Seven Years
    • Incidence of type 2 Diabetes Mellitus during the study
  • Anthropometric changes. Metabolic disease
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Up to Seven Years
    • Study of relationship between existing or new Arrhythmias on clinical events
  • Individual evaluation of all components of the primary outcome.
    • Time Frame: Up to Seven Years
    • Individual apparition of hard cardiovascular events: myocardial infarction revascularization ischemic stroke documented peripheral artery disease cardiovascular death
  • Global Metabolomics
    • Time Frame: 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.
  • Specific metabolomics
    • Time Frame: Up to Seven Years
    • Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
  • Gene Expression
    • Time Frame: Up to Seven Years
    • Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
  • Inflammation and oxidative stress
    • Time Frame: Up to Seven Years
    • Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
  • AGEs
    • Time Frame: Up to Seven Years
    • Metabolism of advanced glycation end products.
  • Mineral metabolism
    • Time Frame: Up to Seven Years
    • Impact of mineral metabolism on atherosclerosis
  • Echographic markers of cardiac function and clinical outcomes
    • Time Frame: Up to Seven Years
    • Cardiac function studies by Echocardiography at baseline and during the study
  • Microparticles
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Reina Sofia de Cordoba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Francisco Perez Jimenez, Chief of Internal Medicine Unit – Hospital Universitario Reina Sofia de Cordoba
  • Overall Official(s)
    • Francisco Perez-Jimenez, MD,PhD, Principal Investigator, Reina Sofia University Hospital

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