Coconut Oil in Cardiovascular Disease

Chronic Coronary Artery Disease Clinical Trial

— HCCO  

Official title:

The Effect of Extra Virgin Coconut Oil Treatment Nutritional Associated With Data Anthropometric and Lipid Profile in Patients With Chronic Heart Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01962844
• Other study ID #: FC 0305
• Status: Active, not recruiting
• Phase: N/A
• First received: October 8, 2013
• Last updated: October 10, 2013
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2013
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Coronary Artery Disease
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• 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.

Behavioral:
• Diet
Patients were instructed to follow the dietary treatment for 6 months

Locations

Country	Name	City	State
Brazil	Instituto Nacional do Coração	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometry	To evaluate the effect of extra virgin coconut oil in the improvement of weight, waist circumference and neck circumference in patients with chronic coronary artery disease	3 months	No
Secondary	Lipid profile	To evaluate the effect of extra virgin coconut oil in lowering total cholesterol, triglycerides, LDL cholesterol and increase in HDL cholesterol	3 months	No
Secondary	Quality of the diet	To evaluating the effect of treatment on the nutritional quality of the diet	3 months	No