Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia

April 5, 2022 updated by: RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar

Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia: A Randomized, add-on, Placebo-controlled Clinical Trial

The present research will help to assess the effect of virgin coconut oil on cholesterol level and also will help to know whether virgin coconut oil can reduce the risk of heart diseases or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dyslipidemia is a well-established risk factor for cardiovascular (CV) diseases. Lipid abnormalities, including high levels of low-density lipoprotein cholesterol (LDL-C), elevated triglycerides and low levels of high-density lipoprotein cholesterol (HDL-C), are independent predictors of CV disease. The National Cholesterol Education Program Adult Treatment Panel III (ATP III) guideline and the American College of Cardiology (ACC) and American Heart Association (AHA) guideline recommend the use of statins for primary prevention based on a patient's cardiovascular risk profile and low-density lipoprotein cholesterol (LDL-C) level. However, statin therapy may be insufficient for patients with mixed dyslipidemia, especially those with metabolic syndromes. While the addition of niacin, fibrate or ezetimibe may be useful in this setting, the combination therapy may lead to more adverse drug reactions.

Virgin Coconut Oil (VCO), a nutraceutical, is an oil obtained from the fresh, mature kernel of the coconut by mechanical or natural means, with or without the use of heat and without undergoing chemical refining and it contains a considerable amount of medium-chain fatty acids similar to those in mother's milk. The beneficial effects of VCO in the reduction of cardiovascular risk have been proved from previous animal and clinical studies. The previous study demonstrated the potential beneficiary effect of VCO in lowering lipid levels in serum and LDL oxidation by physiological oxidants and this property of VCO was attributed to the biologically active polyphenol components present in the oil. It has been also demonstrated the hypolipidemic effect of VCO through activation of lipoprotein lipase, lecithin cholesterol acyltransferase and enhanced formation of bile acids. It was found that isolated polyphenols from VCO can prevent cadmium-induced lipid abnormalities and cardiovascular risk ratios by improving antioxidant defence systems. VCO may improve cardiovascular and hepatic complications in obesity. The findings from another study suggest a beneficial effect of VCO on lipid profile, renal status, hepatic antioxidant defence system, and cardiovascular risk indices in rats. It has been observed that VCO increased HDL-C level in patients with coronary artery disease (CAD). In a randomized crossover trial, it was found that daily consumption of VCO in young healthy adults significantly increased high-density lipoprotein cholesterol without any safety issues.

Our literature search revealed that to date, no clinical trial evaluated the potential of VCO as an add-on hypolipidemic agent in patients suffering from dyslipidemia. So, the present clinical trial has been designed to evaluate the effect of VCO on cardiometabolic parameters as an add-on with statins in patients with dyslipidemia.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

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

  • India
    • Odisha
      • Bhubaneshwar, Odisha, India, 751019
        • AIIMS, Bhubaneswar

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with dyslipidemia [diagnosis of dyslipidemia is made when either of the lipid abnormality is present: LDL-C >140mg/dl, HDL-C <40mg/dl, Triglyceride >150mg/dl according to diagnostic criteria of dyslipidemia ]
  • Patients aged 18-65 years, of either sex.
  • Treatment-naive patients or patients who had not taken any treatment for at least 2 weeks before inclusion.

Exclusion Criteria:

  • History of any cardiovascular diseases, stroke, diabetes, malignancy, musculoskeletal or hepatic diseases
  • History of hypersensitivity to statins or coconut oil
  • Patients who are already under treatment for the presenting conditions.
  • Patients with drug/alcohol abuse.
  • Pregnant and nursing women.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.
Drug: Atorvastatin 10mg
Atorvastatin 10 mg per day
Other: Placebo
Placebo capsule - 1 capsule per day
Experimental: VCO Group
The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).
Drug: Atorvastatin 10mg
Atorvastatin 10 mg per day
Dietary supplement: Virgin Coconut Oil (VCO)
Capsule VCO (1000 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum High Density Lipoprotein (HDL)
Time Frame: Baseline and 8 weeks
Will be measured by autoanalyser
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum Lipoprotein (a)
Time Frame: Baseline and 8 weeks
Will be measured by ELISA
Baseline and 8 weeks
Change in Atherogenic index
Time Frame: Baseline and 8 weeks
Ratio of LDL cholesterol and HDL cholesterol
Baseline and 8 weeks
Change in Coronary risk index
Time Frame: Baseline and 8 weeks
Ratio of total cholesterol and HDL cholesterol
Baseline and 8 weeks
Change in Cardiovascular risk index
Time Frame: Baseline and 8 weeks
Ratio of triglyceride and HDL cholesterol
Baseline and 8 weeks
Change in visceral fat
Time Frame: Baseline and 8 weeks
Will be analysed by by digital body fat analyser
Baseline and 8 weeks
Change in lipid peroxidation
Time Frame: Baseline and 8 weeks
Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method
Baseline and 8 weeks
Change in serum Low Density Lipoprotein (LDL)
Time Frame: Baseline and 8 weeks
Will be measured by autoanalyser
Baseline and 8 weeks
Change in serum Very Low Density Lipoprotein (VLDL)
Time Frame: Baseline and 8 weeks
Will be measured by autoanalyser
Baseline and 8 weeks
Change in serum total cholesterol
Time Frame: Baseline and 8 weeks
Will be measured by autoanalyser
Baseline and 8 weeks
Change in serum triglyceride
Time Frame: Baseline and 8 weeks
Will be measured by autoanalyser
Baseline and 8 weeks

Collaborators and Investigators

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

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Collaborators

Coconut Development Board, Government of India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 22, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/EMF/Pharma/18/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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