Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia
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| ClinicalTrials.gov Identifier: NCT03906539 |
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Recruitment Status :
Completed
First Posted : April 8, 2019
Last Update Posted : April 6, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyslipidemias | Drug: Atorvastatin 10mg Dietary Supplement: Virgin Coconut Oil (VCO) Other: Placebo | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia: A Randomized, add-on, Placebo-controlled Clinical Trial |
| Actual Study Start Date : | May 22, 2019 |
| Actual Primary Completion Date : | November 30, 2021 |
| Actual Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Control Group
The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.
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Drug: Atorvastatin 10mg
Atorvastatin 10 mg per day Other: Placebo Placebo capsule - 1 capsule per day |
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Experimental: VCO Group
The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).
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Drug: Atorvastatin 10mg
Atorvastatin 10 mg per day Dietary Supplement: Virgin Coconut Oil (VCO) Capsule VCO (1000 mg/day) |
- Change in serum High Density Lipoprotein (HDL) [ Time Frame: Baseline and 8 weeks ]Will be measured by autoanalyser
- Change in serum Lipoprotein (a) [ Time Frame: Baseline and 8 weeks ]Will be measured by ELISA
- Change in Atherogenic index [ Time Frame: Baseline and 8 weeks ]Ratio of LDL cholesterol and HDL cholesterol
- Change in Coronary risk index [ Time Frame: Baseline and 8 weeks ]Ratio of total cholesterol and HDL cholesterol
- Change in Cardiovascular risk index [ Time Frame: Baseline and 8 weeks ]Ratio of triglyceride and HDL cholesterol
- Change in visceral fat [ Time Frame: Baseline and 8 weeks ]Will be analysed by by digital body fat analyser
- Change in lipid peroxidation [ Time Frame: Baseline and 8 weeks ]Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method
- Change in serum Low Density Lipoprotein (LDL) [ Time Frame: Baseline and 8 weeks ]Will be measured by autoanalyser
- Change in serum Very Low Density Lipoprotein (VLDL) [ Time Frame: Baseline and 8 weeks ]Will be measured by autoanalyser
- Change in serum total cholesterol [ Time Frame: Baseline and 8 weeks ]Will be measured by autoanalyser
- Change in serum triglyceride [ Time Frame: Baseline and 8 weeks ]Will be measured by autoanalyser
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906539
| India | |
| AIIMS, Bhubaneswar | |
| Bhubaneshwar, Odisha, India, 751019 | |
| Responsible Party: | RITUPARNA MAITI, Additional Professor, All India Institute of Medical Sciences, Bhubaneswar |
| ClinicalTrials.gov Identifier: | NCT03906539 |
| Other Study ID Numbers: |
T/EMF/Pharma/18/23 |
| First Posted: | April 8, 2019 Key Record Dates |
| Last Update Posted: | April 6, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cardiometabolic parameters Virgin coconut oil Serum lipoprotein Lipid peroxidation Atorvastatin |
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Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |