Overview

This trial is active, not recruiting.

Condition chronic coronary artery disease
Treatments coconut oil, diet
Sponsor Universidade Federal do Rio de Janeiro
Collaborator Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Start date January 2012
End date March 2014
Trial size 116 participants
Trial identifier NCT01962844, FC 0305

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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
diet dietary advice
Patients were instructed to follow the dietary treatment for 6 months
(Experimental)
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%
coconut oil coconut oil, palm grease, palmoil
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.

Primary Outcomes

Measure
Anthropometry
time frame: 3 months

Secondary Outcomes

Measure
Lipid profile
time frame: 3 months
Quality of the diet
time frame: 3 months

Eligibility Criteria

Male or female participants from 20 years up to 85 years old.

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.

Additional Information

Official title The Effect of Extra Virgin Coconut Oil Treatment Nutritional Associated With Data Anthropometric and Lipid Profile in Patients With Chronic Heart Disease
Principal investigator Diuli A Cardoso, Ms
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Universidade Federal do Rio de Janeiro.