Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001736235
Ethics application status
Approved
Date submitted
11/10/2018
Date registered
22/10/2018
Date last updated
27/10/2021
Date data sharing statement initially provided
27/10/2021
Date results information initially provided
27/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Virgin coconut oil on cholesterol and glucose level among acute coronary syndrome patients.
Scientific title
The effect of Virgin coconut oil on lipid profile and glucose level among acute coronary syndrome patients : A single blind study
Secondary ID [1] 296316 0
None
Universal Trial Number (UTN)
None
Trial acronym
VCO Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 310026 0
Acute coronary syndrome 310052 0
Condition category
Condition code
Alternative and Complementary Medicine 308779 308779 0 0
Other alternative and complementary medicine
Cardiovascular 308806 308806 0 0
Coronary heart disease
Metabolic and Endocrine 308807 308807 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RCT was conducted among 70 Acute coronary sundrome (ACS) patients for 30 days. Participants were randomly be assigned into the intervention group and control group by using simple random sampling. Participant in group A were received there bottles contain of 100 pieces of Virgin coconut oil (VCO) soft gels each bottles with label A. Participants in group A were instructed to ingest 5 capsules of VCO twice per day (0.5ml/capsule = 10 capsules/5 mls ) for 30 days. They were also continuing routine treatment including consuming Statin medication. While group B remain routine treatment and Statin medication.
After 30 days all subjects were followed-up in the ward for blood taking (Fasting blood sugar and Fasting serum lipid) and anthropometry measurement. They were instructed to fast for at least 10 hour before blood taking. Group A were instructed to bring back the empty label A containers and the amount left was measured in order to monitor the compliance.
Intervention code [1] 312644 0
Treatment: Drugs
Comparator / control treatment
ACS patients with routine treatment such as attending Cardiac rehabilitation program (CRP) , diet education, physical exercise education, and taking Statin medications.
Control group
Active

Outcomes
Primary outcome [1] 307757 0
Serum lipid profile (Total cholesterol, Triglyceride, High desirable lipoprotien (HDL)
and Low desirable lipoprotien (LDL)). It is a composite primary outcome.
Timepoint [1] 307757 0
Day 0 as baseline data and day 30 as endpoint
Primary outcome [2] 307758 0
Serum fasting glucose
Timepoint [2] 307758 0
Day 0 as baseline data and day 30 as endpoint
Secondary outcome [1] 352803 0
Body weight
Body weight and height was measured using Omron Digital Body Weighing Weight Scale on day 0 as baseline and day 30 as post test.
Participants were required to stand on weighing scale with light clothing and
without shoes.
Timepoint [1] 352803 0
Day 0 as baseline data and day 30 as endpoint
Secondary outcome [2] 352804 0
Body mass index (BMI)

Calculation for BMI as following:
1. Divide body weight in kilogram (kg) by height in meters (m) with Omron Digital Weighing Scale
2. than divide the answer by height again
This calculation was calculated by SPSS version 21.0 software.
Timepoint [2] 352804 0
Day 0 as baseline data and day 30 as endpoint

Eligibility
Key inclusion criteria
1. Both gender
2. ACS patients receiving Cardiac rehabilitation program (CRP) program
3. ACS patients with Statin
4. ACS patients understand English and Malay language
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ACS patients with renal failure
2. ACS patients with liver failure
3. ACS patients with pregnancy

Study design
Purpose of the study
Educational / counselling / training
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 envelope consist of code key (A or B). Participants with code A was received three bottles containing 100 soft gels each bottles and continue routine treatment.
Participants with code B, were maintain their routine treatment s such as continue consuming Statin medication, attending CRP program, and regular clinic followup.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Independence t test
2. Paired t test
3. Chi Square

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2018
Date of last participant enrolment
Anticipated
Actual
9/03/2018
Date of last data collection
Anticipated
Actual
23/05/2018
Sample size
Target
80
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 20933 0
Malaysia
State/province [1] 20933 0
Wilayah Persekutuan Kuala Lumpur

Funding & Sponsors
Funding source category [1] 300913 0
Government body
Name [1] 300913 0
MALAYSIA MINISTRY OF SCIENCE, INNOVATION AND TECHNOLOGY
Country [1] 300913 0
Malaysia
Primary sponsor type
Government body
Name
MALAYSIA MINISTRY OF SCIENCE,INNOVATION AND TECHNOLOGY
Address
MINISTRY OF SCIENCE AND TECHNOLOGY (MOSTI)
LEVEL 4, BLOCK C4, COMPLEX C
62662 PUTRAJAYA
MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 300511 0
Other Collaborative groups
Name [1] 300511 0
BIORICH MARKETING
Address [1] 300511 0
Jalan Ppsl 1, Pusat Perniagaan Sungai Lias,
45300 Sungai Besar, Selangor
MALAYSIA
Country [1] 300511 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301681 0
RESEARCH ETHIC COMMITTEE UNIVERSITY OF MALAYA
Ethics committee address [1] 301681 0
Research ethic Committee
University of Malaya,
50603 Kuala Lumpur
MALAYSIA
Ethics committee country [1] 301681 0
Malaysia
Date submitted for ethics approval [1] 301681 0
19/07/2017
Approval date [1] 301681 0
08/08/2017
Ethics approval number [1] 301681 0
2017528-5276

Summary
Brief summary
A randomized single blind study was conducted between from March 2018 to May 2018 to investigate the effect of virgin coconut oil (VCO) on serum lipid profile (cholesterol) on patients with acute coronary syndrome patients’ (ACS).
The study will provide new evidence on the ability of the VCO to reduce cholesterol and glucose level for ACS patients. The findings could help in improving patients’ quality of life which in line one of the Malaysia National Research Agenda.
Trial website
none
Trial related presentations / publications
none
Public notes
none
Attachments [1] 3154 3154 0 0
/AnzctrAttachments/376178-Ethic approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 87770 0
Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 87770 0
NURSING DEPARTMENT FACULTY OF MEDICINE,
UNIVERSITY OF MALAYA 50603
KUALA LUMPUR
MALAYSIA
Country 87770 0
Malaysia
Phone 87770 0
+60132851116
Fax 87770 0
Email 87770 0
shasya@salam.uitm.edu.my
Contact person for public queries
Name 87771 0
Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 87771 0
NURSING DEPARTMENT FACULTY OF MEDICINE,
UNIVERSITY OF MALAYA 50603
KUALA LUMPUR
MALAYSIA
Country 87771 0
Malaysia
Phone 87771 0
0132851116
Fax 87771 0
Email 87771 0
shasyaadrian88@gmail.com
Contact person for scientific queries
Name 87772 0
Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 87772 0
NURSING DEPARTMENT FACULTY OF MEDICINE,
UNIVERSITY OF MALAYA 50603
KUALA LUMPUR
MALAYSIA
Country 87772 0
Malaysia
Phone 87772 0
+60132851116
Fax 87772 0
Email 87772 0
shasya@salam.uitm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.