Coconut Oil in Cardiovascular Disease

NCT ID: NCT01962844

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of this study is to evaluate the supplementation with extra virgin of coconut oil combined with a nutritional counseling in reducing anthropometry and improves the lipid profile in patients with chronic coronary disease.

Detailed Description

The universe of patients with coronary artery disease (CAD) has been increasing steadily worldwide. And associated intimately with certain cardiovascular risk factors such as dyslipidemia , decreased HDL-C , hypertension , diabetes mellitus and obesity. The quality of the fat in the diet influences the incidence of obesity and dyslipidemia. A high intake of saturated fat in different populations is associated with elevated serum cholesterol concentration and cardiovascular mortality. However, studies have shown that extra virgin coconut oil (Cocos nucifera L.) despite being characterized by its high content of saturated fat was not associated with obesity and dyslipidemia in populations that had their high consumption . And this is due to the high proportion of medium chain triglycerides , especially lauric acid in proportions ranging from 45-50 % , and the presence of factors antioxidants like vitamin E and polyphenols. Our hypothesis is that extra virgin coconut oil associated with a nutritional treatment has an effect on weight reduction and control of dyslipidemia contributes to control in secondary prevention in patients with coronary artery disease. All participants will be informed about the research and they must sign a consent form . Volunteers will be divided into two groups : a group receiving dietary treatment for 6 months and the other beyond the dietary treatment during the 6 months starts to receive supplementation with coconut oil extra virgin from 3 months, both groups evaluated monthly . At each visit , weight assessment , compliance with diet and blood pressure measurement is performed. In addition , the blood will also be collected for determination of glucose, insulin, total cholesterol, LDL-cholesterol , HDL-cholesterol, triglycerides , apolipoprotein A and B. The results will be analyzed by the statistical program.It is expected that the results obtained, the extra virgin coconut oil can be used as a coupled secondary prevention in patients with coronary artery disease.Our hypothesis is that extra virgin coconut oil associated with nutritional treatment has an effect on weight reduction and control of dyslipidemia contributes to control in secondary prevention in patients with coronary artery disease.

Conditions

Chronic Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutritional treatment

All patients received an individualized diet plan and balanced. The diet was calculated according to the nutritional status and the protein 15-20% of total energy value, lipids 25-30% of daily energy intake and carbohydrate 50-60% of of total energy value

Group Type: OTHER

Diet

Intervention Type: BEHAVIORAL

Patients were instructed to follow the dietary treatment for 6 months

extra virgim coconut oil group

Oil from coconuts (cocos nucifera L.) contains a high proportion of medium chain fatty acids, principally the lauric acid (12:0), in proportions that range from 45 to 50%

Group Type: EXPERIMENTAL

Coconut Oil

Intervention Type: DIETARY_SUPPLEMENT

Patients were followed for 6 months with dietary treatment. Beginning supplementation with coconut oil extra virgin from the third month of intervention nutrition. Coconut oil was consumed neat or added to fruit.

Interventions

Coconut Oil

Patients were followed for 6 months with dietary treatment. Beginning supplementation with coconut oil extra virgin from the third month of intervention nutrition. Coconut oil was consumed neat or added to fruit.

Intervention Type: DIETARY_SUPPLEMENT

Diet

Patients were instructed to follow the dietary treatment for 6 months

Intervention Type: BEHAVIORAL

Other Intervention Names

coconut oil, palm grease, palmoil; dietary advice

Eligibility Criteria

Inclusion Criteria

Presenting chronic coronary artery disease (myocardial infarction and/or stable angina

Exclusion Criteria

angioplasty and/or coronary artery bypass grafting and previous cardiovascular event <6 months and those who had chronic renal failure with creatinine values> the 2mg/dl and liver disease.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

DIULI ALVES CARDOSO

researcher official

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diuli A Cardoso, Ms

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

Instituto Nacional do Coração

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

FC 0305

Identifier Type: -

Identifier Source: org_study_id