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CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924937
Recruitment Status : Active, not recruiting
First Posted : June 19, 2009
Last Update Posted : November 15, 2019
Information provided by (Responsible Party):
Francisco Perez Jimenez, 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Unstable Angina Malignancy Cognitive Decline Diabetes Mellitus Metabolic Syndrome Behavioral: Mediterranean Diet Behavioral: Low Fat Diet Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2009
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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)
Behavioral: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)

Experimental: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Behavioral: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of intermittent claudication. [ Time Frame: Seven Years ]
  2. Concentration of LDL cholesterol. [ Time Frame: Seven Years ]
  3. Atherogenic ratio Total cholesterol/HDL and LDL/HDL. [ Time Frame: Seven Years ]
  4. Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose). [ Time Frame: Seven Years ]
  5. Blood pressure. [ Time Frame: Seven Years ]
  6. Incidence of malignancy. [ Time Frame: Seven Years ]
  7. Progression of Cognitive Decline. [ Time Frame: Seven Years ]
  8. 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.

  9. Extended composite of heart events [ Time Frame: Seven Years ]
    Cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest

  10. Incidence of type 2 Diabetes Mellitus [ Time Frame: Up to Seven Years ]
  11. Incidence of Metabolic Syndrome [ Time Frame: Up to Seven Years ]
  12. Composition of the different families of Gut Microbiota [ Time Frame: Up to Seven Years ]
    Changes in the percentage of different families of Microbiota will be analyzed during the study

Other Outcome Measures:
  1. Endothelial function (Flow mediated dilation) [ Time Frame: Up to Seven Years ]
    Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed

  2. genetics [ Time Frame: Up to seven years ]
    Influence of genotype in the development of type 2 dm, at 1, 2, 4 and 7 years

  3. postprandial lipaemia [ Time Frame: Up to seven years ]
    Influence of metabolic phenotypes and diet on postprandial lipemia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924937

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Reina Sofia University Hospital
Cordoba, Spain, 14001
Sponsors and Collaborators
Hospital Universitario Reina Sofia de Cordoba
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Principal Investigator: Francisco Perez-Jimenez, MD,PhD Reina Sofia University Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Francisco Perez Jimenez, Chief of Internal Medicine Unit, Hospital Universitario Reina Sofia de Cordoba Identifier: NCT00924937    
Other Study ID Numbers: CORDIOPREV
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francisco Perez Jimenez, Hospital Universitario Reina Sofia de Cordoba:
Cardiovascular events
Blood pressure
Incidence of Cancer
Cognitive decline
Mediterranean Diet
Secondary Prevention
Low fat diet
Additional relevant MeSH terms:
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Myocardial Infarction
Angina, Unstable
Metabolic Syndrome
Cognitive Dysfunction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Angina Pectoris
Chest Pain
Neurologic Manifestations
Signs and Symptoms