NCT03906539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 22, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

April 5, 2019

Last Update Submit

April 5, 2022

Conditions

Dyslipidemias

Keywords

Cardiometabolic parametersVirgin coconut oilSerum lipoproteinLipid peroxidationAtorvastatin

Outcome Measures

Primary Outcomes (1)

  • Change in serum High Density Lipoprotein (HDL)

    Will be measured by autoanalyser

    Baseline and 8 weeks

Secondary Outcomes (10)

  • Change in serum Lipoprotein (a)

    Baseline and 8 weeks

  • Change in Atherogenic index

    Baseline and 8 weeks

  • Change in Coronary risk index

    Baseline and 8 weeks

  • Change in Cardiovascular risk index

    Baseline and 8 weeks

  • Change in visceral fat

    Baseline and 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Control Group

PLACEBO COMPARATOR

The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.

Drug: Atorvastatin 10mgOther: Placebo

VCO Group

EXPERIMENTAL

The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).

Drug: Atorvastatin 10mgDietary Supplement: Virgin Coconut Oil (VCO)

Interventions

Atorvastatin 10mgDRUG

Atorvastatin 10 mg per day

Control GroupVCO Group
Virgin Coconut Oil (VCO)DIETARY_SUPPLEMENT

Capsule VCO (1000 mg/day)

VCO Group
PlaceboOTHER

Placebo capsule - 1 capsule per day

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIIMS, Bhubaneswar

Bhubaneshwar, Odisha, 751019, India

Location

Related Publications (15)

  • 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 study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PMID: 15364185RESULT

  • 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. doi: 10.1161/01.cir.79.1.8.

    PMID: 2642759RESULT

  • 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. Circulation. 2007 Jan 30;115(4):450-8. doi: 10.1161/CIRCULATIONAHA.106.637793. Epub 2006 Dec 26.

    PMID: 17190864RESULT

  • 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. doi: 10.1001/jama.298.3.309.

    PMID: 17635891RESULT

  • 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 trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004 Jul 13;110(2):227-39. doi: 10.1161/01.CIR.0000133317.49796.0E.

    PMID: 15249516RESULT

  • 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. No abstract available.

    PMID: 24222016RESULT

  • 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 Diet Suppl. 2018 May 4;15(3):330-342. doi: 10.1080/19390211.2017.1346031. Epub 2017 Aug 17.

    PMID: 28816548RESULT

  • 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. doi: 10.1016/j.clinbiochem.2004.04.010.

    PMID: 15329324RESULT

  • 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.

    PMID: 23305031RESULT

  • [Should the specialist examination be introduced? Thoughts of the Education Committee]. Ugeskr Laeger. 1969 Jan 23;131(4):170-1. No abstract available. Danish.

    PMID: 5787998RESULT

  • 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.

    PMID: 29079969RESULT

  • 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: 10.3305/nh.2015.32.5.9642.

    PMID: 26545671RESULT

  • 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: 10.1155/2017/7251562. Epub 2017 Dec 14.

    PMID: 29387131RESULT

  • 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 for dyslipidemia. Executive summary of Japan Atherosclerosis Society (JAS) guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese. J Atheroscler Thromb. 2007 Aug;14(4):155-8. doi: 10.5551/jat.e537. No abstract available.

    PMID: 17827859RESULT

  • Ermakova GL, Abakumov EM, Martynova VA. [Immunological and microbiological parallels in pneumonia complicating leukemia]. Klin Med (Mosk). 1973 Feb;51(2):29-32. No abstract available. Russian.

    PMID: 4700825RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

May 22, 2019

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)