Coconut Oil in Cardiovascular Disease (HCCO)

October 10, 2013 updated by: DIULI ALVES CARDOSO, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22240-002
        • Instituto Nacional do Coração

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
Behavioral: Diet
Patients were instructed to follow the dietary treatment for 6 months
Other Names:
  • dietary advice
EXPERIMENTAL: 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%
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.
Other Names:
  • coconut oil, palm grease, palmoil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometry
Time Frame: 3 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 3 months
To evaluate the effect of extra virgin coconut oil in lowering total cholesterol, triglycerides, LDL cholesterol and increase in HDL cholesterol
3 months
Quality of the diet
Time Frame: 3 months
To evaluating the effect of treatment on the nutritional quality of the diet
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Diuli A Cardoso, Ms, Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (ESTIMATE)

October 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FC 0305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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