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
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
Trial website
Trial related presentations / publications
Public notes
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
[email protected]
Contact person for public queries
Name 83035 0
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
[email protected]
Contact person for scientific queries
Name 83036 0
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
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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