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NCT Number: NCT03906539

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AIIMS, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin 10mg

Drug

Atorvastatin 10 mg per day

Virgin Coconut Oil (VCO)

Dietary Supplement

Capsule VCO (1000 mg/day)

Placebo

Other

Placebo capsule - 1 capsule per day

Primary outcomes

  1. Change in serum High Density Lipoprotein (HDL)

    Time frame: Baseline and 8 weeks

    Will be measured by autoanalyser

Secondary outcomes

  1. Change in serum Lipoprotein (a)

    Time frame: Baseline and 8 weeks

    Will be measured by ELISA

  2. Change in Atherogenic index

    Time frame: Baseline and 8 weeks

    Ratio of LDL cholesterol and HDL cholesterol

  3. Change in Coronary risk index

    Time frame: Baseline and 8 weeks

    Ratio of total cholesterol and HDL cholesterol

  4. Change in Cardiovascular risk index

    Time frame: Baseline and 8 weeks

    Ratio of triglyceride and HDL cholesterol

  5. Change in visceral fat

    Time frame: Baseline and 8 weeks

    Will be analysed by by digital body fat analyser

  6. Change in lipid peroxidation

    Time frame: Baseline and 8 weeks

    Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method

  7. Change in serum Low Density Lipoprotein (LDL)

    Time frame: Baseline and 8 weeks

    Will be measured by autoanalyser

  8. Change in serum Very Low Density Lipoprotein (VLDL)

    Time frame: Baseline and 8 weeks

    Will be measured by autoanalyser

  9. Change in serum total cholesterol

    Time frame: Baseline and 8 weeks

    Will be measured by autoanalyser

  10. Change in serum triglyceride

    Time frame: Baseline and 8 weeks

    Will be measured by autoanalyser

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Collaborators

  • Coconut Development Board, Government of India

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2019
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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