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Trial registered on ANZCTR

Registration number

ACTRN12618000752268

Ethics application status

Approved

Date submitted

26/04/2018

Date registered

4/05/2018

Date last updated

4/05/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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.

Secondary ID [1]

NONE

Universal Trial Number (UTN)

Trial acronym

VCO & LIPID

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute coronary syndrome

Level of lipid profile

Level of glucose (fasting blood sugar and Hba1c)

Level of Hs crp

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

Diabetes

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Virgin olive oil

Control group

Active

Outcomes

Primary outcome [1]

Serum lipid profile
1. Total cholesterol
2. Triglyceride
3. HDL
4. LDL

Timepoint [1]

1. VCO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VOO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

2. VOO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VCO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

*Serum lipid profile will be taken 7 times start from baseline (day 0) until day 270.

Primary outcome [2]

Serum glucose level (Fasting blood sugar)

Timepoint [2]

1. VCO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VOO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

2. VOO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VCO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

*Serum for fasting blood sugar will be taken 7 times start from baseline (day 0) until day 270.

Primary outcome [3]

Serum hs crp

Timepoint [3]

1. VCO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VOO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

2. VOO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VCO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

*Serum for Hs Crp will be taken 7 times start from baseline (day 0) until day 270.

Secondary outcome [1]

Level of quality of life
This outcome measure through MacNew quality of life after myocardial infarction questionnaire (Macnew QLMI) (with permission)

Timepoint [1]

1. VCO group = Baseline and day 90

2. VOO group = Baseline, and day 90

*Measurement for level of quality of life will be assessed twice start from baseline (day 0) until day 90 (both groups)

Secondary outcome [2]

Serum for HbA1c

* this is one of primary outcomes

Timepoint [2]

1. VCO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VOO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

2. VOO group = Baseline, 30 days, 60 days and 90 days - washout (90 days = day 180) received VCO , then 30 days (day 210), 60 days (day 230) and 90 days (day 270) Total period is 270 days

*Serum for HbA1c will be taken 7 times start from baseline (day 0) until day 270.

Eligibility

Key inclusion criteria

Inclusion criteria
• Age 20 to 65
• Patients with stable acute coronary syndrome (ACS)
• Both genders
• Willing to ingest 5 soft gel twice time per day
• Understand Malay and English language

Minimum age

20 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria
• Pregnant patients
• Patients with uncontrolled hypothyroidism
• Patients with renal failure creatinine >2mg/dL
• Patients with liver failure
• Patients with other illness limiting the life expectancy less than 2 years

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization Participants will randomly be assigned to either the intervention or control group using simple random sampling. Random numbers will be generated through StarTrek Number Generator (from web). Each participants will receive one envelop consist of code key (A or B) and one bottle contain 450 soft gels. In order to maintain concealment of treatment, soft gels from both bottles will appear similar in term of size, color, amount, odor and flavor. In order to differentiate between these soft gels, the bottle contains VCO soft gel will be labeled as A and placebo (VOO) as B. This is a double blind study where participants, researcher and medical laboratory technicians (outcome assessor) will not be exposed the code key.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random number sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Randomized crossover design

Phase

Phase 1 / Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

1. Independence t test
2. paired t test
4. ANOVA
3. Logistic regression

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

5/03/2018

Date of last participant enrolment

Anticipated

30/08/2018

Actual

Date of last data collection

Anticipated

30/05/2019

Actual

Sample size

Target

160

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

KUALA LUMPUR

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

MALAYSIA MINISTRY OF SCIENCE AND TECHNOLOGY

Address [1]

MINISTRY OF SCIENCE AND TECHNOLOGY (MOSTI)
LEVEL 4, BLOCK C4, COMPLEX C
62662 PUTRAJAYA MALAYSIA

Country [1]

Malaysia

Primary sponsor type

Government body

Name

MOSTI

Address

MINISTRY OF SCIENCE AND TECHNOLOGY (MOSTI)
LEVEL 4, BLOCK C4, COMPLEX C
62662 PUTRAJAYA
MALAYSIA

Country

Malaysia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

BIORICH MARKETING

Address [1]

Jalan Ppsl 1, Pusat Perniagaan Sungai Lias,
45300 Sungai Besar, Selangor
MALAYSIA

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNIVERSITY OF MALAYA RESEARCH ETHIC COMMITTEE

Ethics committee address [1]

Research ethic Committee 
University of Malaya, 
50603 Kuala Lumpur
MALAYSIA

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

19/07/2017

Approval date [1]

08/08/2017

Ethics approval number [1]

2017528-5276

Summary

Brief 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

Trial website

None

Trial related presentations / publications

None

Public notes

None

Attachments [1]

/AnzctrAttachments/374994-Ethic approval.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/374994-Consent_editted_2.pdf (Participant information/consent)

Contacts

Principal investigator

Name

Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH

Address

NURSING DEPARTMENT
FACULTY OF MEDICINE, UNIVERSITY OF MALAYA
50603 KUALA LUMPUR
MALAYSIA

Country

Malaysia

Phone

+60132851116

Fax

+60379676686

shasya@salam.uitm.edu.my

Contact person for public queries

Name

SHARIFAH SHAFINAZ BINTI SH ABDULLAH

Address

NURSING DEPARTMENT
FACULTY OF MEDICINE, UNIVERSITY OF MALAYA
50603 KUALA LUMPUR
MALAYSIA

Country

Malaysia

Phone

+60132851116

Fax

+60379676686

shasya@salam.uitm.edu.my

Contact person for scientific queries

Name

SHARIFAH SHAFINAZ BINTI SH ABDULLAH

Address

NURSING DEPARTMENT
FACULTY OF MEDICINE, UNIVERSITY OF MALAYA
50603 KUALA LUMPUR
MALAYSIA

Country

Malaysia

Phone

+60132851116

Fax

+60379676686

shasya@salam.uitm.edu.my

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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