Clinical trial NCT03906539: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Keywords: Cardiometabolic parameters
Virgin coconut oil
Serum lipoprotein
Lipid peroxidation
Atorvastatin
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
Collaborators: name: Coconut Development Board, Government of India
First posted: 2019-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in serum High Density Lipoprotein (HDL)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in serum Lipoprotein (a)
timeFrame: Baseline and 8 weeks
measure: Change in Atherogenic index
timeFrame: Baseline and 8 weeks
measure: Change in Coronary risk index
timeFrame: Baseline and 8 weeks
measure: Change in Cardiovascular risk index
timeFrame: Baseline and 8 weeks
measure: Change in visceral fat
timeFrame: Baseline and 8 weeks
measure: Change in lipid peroxidation
timeFrame: Baseline and 8 weeks
measure: Change in serum Low Density Lipoprotein (LDL)
timeFrame: Baseline and 8 weeks
measure: Change in serum Very Low Density Lipoprotein (VLDL)
timeFrame: Baseline and 8 weeks
measure: Change in serum total cholesterol
timeFrame: Baseline and 8 weeks
measure: Change in serum triglyceride
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Bhubaneshwar
country: India
facility: AIIMS, Bhubaneswar
state: Odisha
Study officials:
References:
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