Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Atorvastatin 10mg
Virgin Coconut Oil (VCO)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring Cardiometabolic parameters, Virgin coconut oil, Serum lipoprotein, Lipid peroxidation, Atorvastatin
Eligibility Criteria
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.
Sites / Locations
- AIIMS, Bhubaneswar
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
VCO Group
Arm Description
The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.
The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).
Outcomes
Primary Outcome Measures
Change in serum High Density Lipoprotein (HDL)
Will be measured by autoanalyser
Secondary Outcome Measures
Change in serum Lipoprotein (a)
Will be measured by ELISA
Change in Atherogenic index
Ratio of LDL cholesterol and HDL cholesterol
Change in Coronary risk index
Ratio of total cholesterol and HDL cholesterol
Change in Cardiovascular risk index
Ratio of triglyceride and HDL cholesterol
Change in visceral fat
Will be analysed by by digital body fat analyser
Change in lipid peroxidation
Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method
Change in serum Low Density Lipoprotein (LDL)
Will be measured by autoanalyser
Change in serum Very Low Density Lipoprotein (VLDL)
Will be measured by autoanalyser
Change in serum total cholesterol
Will be measured by autoanalyser
Change in serum triglyceride
Will be measured by autoanalyser
Full Information
NCT ID
NCT03906539
First Posted
April 5, 2019
Last Updated
April 5, 2022
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Collaborators
Coconut Development Board, Government of India
1. Study Identification
Unique Protocol Identification Number
NCT03906539
Brief Title
Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia
Official Title
Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia: A Randomized, add-on, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Collaborators
Coconut Development Board, Government of India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
Cardiometabolic parameters, Virgin coconut oil, Serum lipoprotein, Lipid peroxidation, Atorvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.
Arm Title
VCO Group
Arm Type
Experimental
Arm Description
The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 10mg
Intervention Description
Atorvastatin 10 mg per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Virgin Coconut Oil (VCO)
Intervention Description
Capsule VCO (1000 mg/day)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule - 1 capsule per day
Primary Outcome Measure Information:
Title
Change in serum High Density Lipoprotein (HDL)
Description
Will be measured by autoanalyser
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in serum Lipoprotein (a)
Description
Will be measured by ELISA
Time Frame
Baseline and 8 weeks
Title
Change in Atherogenic index
Description
Ratio of LDL cholesterol and HDL cholesterol
Time Frame
Baseline and 8 weeks
Title
Change in Coronary risk index
Description
Ratio of total cholesterol and HDL cholesterol
Time Frame
Baseline and 8 weeks
Title
Change in Cardiovascular risk index
Description
Ratio of triglyceride and HDL cholesterol
Time Frame
Baseline and 8 weeks
Title
Change in visceral fat
Description
Will be analysed by by digital body fat analyser
Time Frame
Baseline and 8 weeks
Title
Change in lipid peroxidation
Description
Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method
Time Frame
Baseline and 8 weeks
Title
Change in serum Low Density Lipoprotein (LDL)
Description
Will be measured by autoanalyser
Time Frame
Baseline and 8 weeks
Title
Change in serum Very Low Density Lipoprotein (VLDL)
Description
Will be measured by autoanalyser
Time Frame
Baseline and 8 weeks
Title
Change in serum total cholesterol
Description
Will be measured by autoanalyser
Time Frame
Baseline and 8 weeks
Title
Change in serum triglyceride
Description
Will be measured by autoanalyser
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AIIMS, Bhubaneswar
City
Bhubaneshwar
State/Province
Odisha
ZIP/Postal Code
751019
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia
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