Clinical trial NCT01962844: Coconut Oil in Cardiovascular Disease
Official title: The Effect of Extra Virgin Coconut Oil Treatment Nutritional Associated With Data Anthropometric and Lipid Profile in Patients With Chronic Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Coronary Artery Disease
Keywords: chronic coronary artery disease
coconut oil extra virgin
index of diet quality
nutritional treatment
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-10-14
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Anthropometry
timeFrame: 3 months
Secondary outcomes:
measure: Lipid profile
timeFrame: 3 months
measure: Quality of the diet
timeFrame: 3 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Coração
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Diuli A Cardoso, Ms
role: PRINCIPAL_INVESTIGATOR
References: