RecruitingPhase 2ACTRN12618000752268

The effect of Virgin coconut oil on quality of life and serum lipid profile, glucose level and Hs Crp among acute coronary syndrome patients

The effect of Virgin coconut oil on quality of life and serum lipid profile, glucose level and Hs Crp among acute coronary syndrome patients : A randomized crossover study.


Sponsor

MOSTI

Enrollment

160 participants

Start Date

Mar 5, 2018

Study Type

Interventional

Conditions

Summary

Acute coronary syndrome (ACS) has been proven to be resulted from accumulation of lipid in the intima layer of the coronary arteries. This plague known as atherosclerosis causes narrowing the arteries and prevent blood supply to myocardium. The myocardium when deprived of oxygen and nutrition will cause patient to suffer from myocardium infarction. Although a range of synthetic drugs are available such as antihypercholesterolemic drugs their numerous side effects are widely reported by recent systemic review on clinical trial studies from many countries. In Malaysia, there are many natural sources which are claimed to be as effective as those marketable pharmacological agents. One of the Malaysia natural sources is Virgin coconut oil (VCO) which is widely reported to be effective in lowering lipid profile and glucose level. The research on nutraceutical sources for reduction of serum and plasma cholesterol and reduction of hypercholesterol atherosclerosis is still ongoing and might provide a better source for therapy or alternatively as simple supplement adjunct to existing therapies. Various clinical trials on animal studies have found the VCO has many beneficial effects on health. Despite claims from a few studies on VCO significant effects, there have been limited published studies on pharmacological properties of VCO using human as the subject of study. Therefore, the aim of this cross over trial study is to investigate the potential VCO as an anticholesterol, antihyperglacemic agent and anti-inflammation for ACS patients. In addition, this study also want to investigate the level of quality of life among ACS patients. Statistical analysis included descriptive statistics, Chi-Square test of Association, Fisher’s exact test, independent t-tests for means and proportions. Investigation on human study is extremely required in order to provide more empirical evidence to show the effect of VCO for ACS patients and eventually support VCO as an alternative or supplement to improve the health of ACS patients. Significance of study (Relevance to government policy) The study will provide new evidence on the ability of the VCO to reduce cholesterol and glucose level as well as able to be an anti-inflammation agent for CHD patients. The findings could help in improving patients’ quality of life which in line one of the Malaysia National Research Agenda. This outcome also can increased country income by promoting the local product to worldwide. The organization could increase the reputation on the ability of VCO in early detection and prevention of CHD as well as reduce morbidity and mortality of CHD. This study also is inline with National Learning Strategic Planning third principle which is “Strengthen research and innovation”. This project has been approved by University of Malaya Ethic committee on the 08/08/2017


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Acute coronary syndrome (ACS) — a term that covers heart attacks and severe angina — results from the build-up of fatty plaques in the arteries supplying the heart. Standard treatment usually involves cholesterol-lowering medications, but these drugs can have side effects that lead some patients to look for natural alternatives. This study from Malaysia is investigating whether virgin coconut oil (VCO) — a natural oil widely used in Southeast Asia and believed by some to have cholesterol-lowering and anti-inflammatory properties — can benefit ACS patients when taken alongside their standard care. In a crossover design, participants will take VCO soft gel capsules for a period, then switch to a control, and researchers will measure changes in cholesterol levels, blood sugar, inflammatory markers, and quality of life. The study aims to provide proper scientific evidence for or against VCO as a complementary supplement for heart patients. You may be eligible if you are between 20 and 65 years old, have stable ACS, speak Malay or English, and are willing to take soft gel capsules twice daily. Pregnant women and people with uncontrolled thyroid disease, kidney failure, liver failure, or a life-limiting illness are not eligible. This is a Phase 2 trial registered at Hospital Universiti Malaya in Malaysia.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

1. Participants will received 5 capsules of Virgin coconut oil twice per day ( 0.5ml/capsule = 10 capsules/5 mls ) for 90 days. After 90 days they place in washout period for 90 days and proceed with

1. Participants will received 5 capsules of Virgin coconut oil twice per day ( 0.5ml/capsule = 10 capsules/5 mls ) for 90 days. After 90 days they place in washout period for 90 days and proceed with virgin olive oil (VOO) 5 capsules twice per day for another 90 days. 2. Assignment of starting capsules is randomised 3. All subjects are followed-up every 4 weeks. They are instructed to bring back the empty containers of the VCO or VOO and the amount left is measured in order to monitor the compliance.


Locations(1)

KUALA LUMPUR, Malaysia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12618000752268