search
Back to results

Coconut Oil in Cardiovascular Disease (HCCO)

Primary Purpose

Chronic Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Coconut Oil
Diet
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Coronary Artery Disease focused on measuring chronic coronary artery disease, coconut oil extra virgin, index of diet quality, nutritional treatment

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Nacional do Coração

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Nutritional treatment

extra virgim coconut oil group

Arm Description

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

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%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lipid profile
To evaluate the effect of extra virgin coconut oil in lowering total cholesterol, triglycerides, LDL cholesterol and increase in HDL cholesterol
Quality of the diet
To evaluating the effect of treatment on the nutritional quality of the diet

Full Information

First Posted
October 8, 2013
Last Updated
October 10, 2013
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT01962844
Brief Title
Coconut Oil in Cardiovascular Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Artery Disease
Keywords
chronic coronary artery disease, coconut oil extra virgin, index of diet quality, nutritional treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional treatment
Arm Type
Other
Arm Description
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
Arm Title
extra virgim coconut oil group
Arm Type
Experimental
Arm Description
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%
Intervention Type
Dietary Supplement
Intervention Name(s)
Coconut Oil
Other Intervention Name(s)
coconut oil, palm grease, palmoil
Intervention Description
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
Behavioral
Intervention Name(s)
Diet
Other Intervention Name(s)
dietary advice
Intervention Description
Patients were instructed to follow the dietary treatment for 6 months
Primary Outcome Measure Information:
Title
Anthropometry
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lipid profile
Description
To evaluate the effect of extra virgin coconut oil in lowering total cholesterol, triglycerides, LDL cholesterol and increase in HDL cholesterol
Time Frame
3 months
Title
Quality of the diet
Description
To evaluating the effect of treatment on the nutritional quality of the diet
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diuli A Cardoso, Ms
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional do Coração
City
Rio de Janeiro
ZIP/Postal Code
22240-002
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Coconut Oil in Cardiovascular Disease

We'll reach out to this number within 24 hrs