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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906539
• Other study ID #: T/EMF/Pharma/18/23
• Status: Completed
• Phase: Phase 4
• Start date: May 22, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Atorvastatin 10mg
Atorvastatin 10 mg per day

Dietary Supplement:
• Virgin Coconut Oil (VCO)
Capsule VCO (1000 mg/day)

Other:
• Placebo
Placebo capsule - 1 capsule per day

Locations

Country	Name	City	State
India	AIIMS, Bhubaneswar	Bhubaneshwar	Odisha

Sponsors (2)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar	Coconut Development Board, Government of India

Country where clinical trial is conducted

India, 

References & Publications (15)

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Arunima S, Rajamohan T. Virgin coconut oil improves hepatic lipid metabolism in rats--compared with copra oil, olive oil and sunflower oil. Indian J Exp Biol. 2012 Nov;50(11):802-9. — View Citation

Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. — View Citation

Cardoso DA, Moreira AS, de Oliveira GM, Raggio Luiz R, Rosa G. A COCONUT EXTRA VIRGIN OIL-RICH DIET INCREASES HDL CHOLESTEROL AND DECREASES WAIST CIRCUMFERENCE AND BODY MASS IN CORONARY ARTERY DISEASE PATIENTS. Nutr Hosp. 2015 Nov 1;32(5):2144-52. doi: 10 — View Citation

Chinwong S, Chinwong D, Mangklabruks A. Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial. Evid Based Complement Alternat Med. 2017;2017:7251562. doi: 10.1155/ — View Citation

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Famurewa AC, Ekeleme-Egedigwe CA, Nwali SC, Agbo NN, Obi JN, Ezechukwu GC. Dietary Supplementation with Virgin Coconut Oil Improves Lipid Profile and Hepatic Antioxidant Status and Has Potential Benefits on Cardiovascular Risk Indices in Normal Rats. J Di — View Citation

Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs DR Jr, Bangdiwala S, Tyroler HA. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation. 1989 Jan;79(1):8-15. — View Citation

Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical — View Citation

Nevin KG, Rajamohan T. Beneficial effects of virgin coconut oil on lipid parameters and in vitro LDL oxidation. Clin Biochem. 2004 Sep;37(9):830-5. — View Citation

Panchal SK, Carnahan S, Brown L. Coconut Products Improve Signs of Diet-Induced Metabolic Syndrome in Rats. Plant Foods Hum Nutr. 2017 Dec;72(4):418-424. doi: 10.1007/s11130-017-0643-0. — View Citation

Sarwar N, Danesh J, Eiriksdottir G, Sigurdsson G, Wareham N, Bingham S, Boekholdt SM, Khaw KT, Gudnason V. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulatio — View Citation

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, — View Citation

Teramoto T, Sasaki J, Ueshima H, Egusa G, Kinoshita M, Shimamoto K, Daida H, Biro S, Hirobe K, Funahashi T, Yokote K, Yokode M; Japan Atherosclerosis Society (JAS) Committee for Epidemiology and Clinical Management of Atherosclerosis. Diagnostic criteria — View Citation

Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART s — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum High Density Lipoprotein (HDL)	Will be measured by autoanalyser	Baseline and 8 weeks
Secondary	Change in serum Lipoprotein (a)	Will be measured by ELISA	Baseline and 8 weeks
Secondary	Change in Atherogenic index	Ratio of LDL cholesterol and HDL cholesterol	Baseline and 8 weeks
Secondary	Change in Coronary risk index	Ratio of total cholesterol and HDL cholesterol	Baseline and 8 weeks
Secondary	Change in Cardiovascular risk index	Ratio of triglyceride and HDL cholesterol	Baseline and 8 weeks
Secondary	Change in visceral fat	Will be analysed by by digital body fat analyser	Baseline and 8 weeks
Secondary	Change in lipid peroxidation	Thiobarbituric acid reactive substances (TBARS) will be estimated by spectrofluorometric method	Baseline and 8 weeks
Secondary	Change in serum Low Density Lipoprotein (LDL)	Will be measured by autoanalyser	Baseline and 8 weeks
Secondary	Change in serum Very Low Density Lipoprotein (VLDL)	Will be measured by autoanalyser	Baseline and 8 weeks
Secondary	Change in serum total cholesterol	Will be measured by autoanalyser	Baseline and 8 weeks
Secondary	Change in serum triglyceride	Will be measured by autoanalyser	Baseline and 8 weeks