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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03906539
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Coconut Development Board, Government of India
Information provided by (Responsible Party):
RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: Atorvastatin 10mg Dietary Supplement: Virgin Coconut Oil (VCO) Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Change in serum High Density Lipoprotein (HDL) [ Time Frame: Baseline and 8 weeks ]
    Will be measured by autoanalyser


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: RITUPARNA MAITI, MD 09438884191 pharm_rituparna@aiimsbhubaneswar.edu.in
Contact: RASHMI R MOHANTY, MD genmed_rashmi@aiimsbhubaneswar.edu.in

Locations
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India
AIIMS, Bhubaneswar Recruiting
Bhubaneshwar, Odisha, India, 751019
Contact: RITUPARNA MAITI, MD       rituparnamaiti@gmail.com   
Sub-Investigator: RASHMI R MOHANTY, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Coconut Development Board, Government of India

Publications of Results:
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Erratum in: Circulation. 2015 Dec 22;132(25):e396.

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Responsible Party: RITUPARNA MAITI, Additional Professor, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT03906539     History of Changes
Other Study ID Numbers: T/EMF/Pharma/18/23
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar:
Cardiometabolic parameters
Virgin coconut oil
Serum lipoprotein
Lipid peroxidation
Atorvastatin
Additional relevant MeSH terms:
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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