Trial Review

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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] 294747 0
NONE
Universal Trial Number (UTN)
Trial acronym
VCO & LIPID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 307612 0
Level of lipid profile 307613 0
Level of glucose (fasting blood sugar and Hba1c) 307614 0
Level of Hs crp 307615 0
Condition category
Condition code
Cardiovascular 306669 306669 0 0
Coronary heart disease
Metabolic and Endocrine 306671 306671 0 0
Diabetes
Alternative and Complementary Medicine 306707 306707 0 0
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] 301025 0
Treatment: Other
Comparator / control treatment
Virgin olive oil
Control group
Active

Outcomes
Primary outcome [1] 305676 0
Serum lipid profile
1. Total cholesterol
2. Triglyceride
3. HDL
4. LDL
Timepoint [1] 305676 0
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] 305677 0
Serum glucose level (Fasting blood sugar)
Timepoint [2] 305677 0
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] 305678 0
Serum hs crp
Timepoint [3] 305678 0
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] 346136 0
Level of quality of life
This outcome measure through MacNew quality of life after myocardial infarction questionnaire (Macnew QLMI) (with permission)
Timepoint [1] 346136 0
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] 346409 0
Serum for HbA1c

* this is one of primary outcomes
Timepoint [2] 346409 0
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?
No
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
35
Final
Recruitment outside Australia
Country [1] 10356 0
Malaysia
State/province [1] 10356 0
KUALA LUMPUR

Funding & Sponsors
Funding source category [1] 299339 0
Government body
Name [1] 299339 0
MALAYSIA MINISTRY OF SCIENCE AND TECHNOLOGY
Country [1] 299339 0
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] 298608 0
Commercial sector/Industry
Name [1] 298608 0
BIORICH MARKETING
Address [1] 298608 0
Jalan Ppsl 1, Pusat Perniagaan Sungai Lias,
45300 Sungai Besar, Selangor
MALAYSIA
Country [1] 298608 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300246 0
UNIVERSITY OF MALAYA RESEARCH ETHIC COMMITTEE
Ethics committee address [1] 300246 0
Research ethic Committee
University of Malaya,
50603 Kuala Lumpur
MALAYSIA
Ethics committee country [1] 300246 0
Malaysia
Date submitted for ethics approval [1] 300246 0
19/07/2017
Approval date [1] 300246 0
08/08/2017
Ethics approval number [1] 300246 0
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] 2635 2635 0 0
/AnzctrAttachments/374994-Ethic approval.pdf (Ethics approval)
Attachments [2] 2636 2636 0 0
/AnzctrAttachments/374994-Consent_editted_2.pdf (Participant information/consent)

Contacts
Principal investigator
Name 83034 0
Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 83034 0
NURSING DEPARTMENT
FACULTY OF MEDICINE, UNIVERSITY OF MALAYA
50603 KUALA LUMPUR
MALAYSIA
Country 83034 0
Malaysia
Phone 83034 0
+60132851116
Fax 83034 0
+60379676686
Email 83034 0
shasya@salam.uitm.edu.my
Contact person for public queries
Name 83035 0
Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 83035 0
NURSING DEPARTMENT
FACULTY OF MEDICINE, UNIVERSITY OF MALAYA
50603 KUALA LUMPUR
MALAYSIA
Country 83035 0
Malaysia
Phone 83035 0
+60132851116
Fax 83035 0
+60379676686
Email 83035 0
shasya@salam.uitm.edu.my
Contact person for scientific queries
Name 83036 0
Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 83036 0
NURSING DEPARTMENT
FACULTY OF MEDICINE, UNIVERSITY OF MALAYA
50603 KUALA LUMPUR
MALAYSIA
Country 83036 0
Malaysia
Phone 83036 0
+60132851116
Fax 83036 0
+60379676686
Email 83036 0
shasya@salam.uitm.edu.my

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23626Study protocol https://drive.google.com/drive/folders/1emr-SQT98o68CY4KSp3m-t2QIl25yyCh?usp=sharing 
23627Informed consent form https://drive.google.com/drive/folders/1emr-SQT98o68CY4KSp3m-t2QIl25yyCh?usp=sharing 
23628Ethical approval https://drive.google.com/drive/folders/1emr-SQT98o68CY4KSp3m-t2QIl25yyCh?usp=sharing 

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.