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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.
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Scientific title
The effect of Virgin coconut oil on lipid profile and glucose level among acute coronary syndrome patients : A single blind study
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Secondary ID [1]
296316
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None
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Universal Trial Number (UTN)
None
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Trial acronym
VCO Study
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus
310026
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Acute coronary syndrome
310052
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Condition category
Condition code
Alternative and Complementary Medicine
308779
308779
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0
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Other alternative and complementary medicine
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Cardiovascular
308806
308806
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0
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Coronary heart disease
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Metabolic and Endocrine
308807
308807
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
312644
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Treatment: Drugs
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Comparator / control treatment
ACS patients with routine treatment such as attending Cardiac rehabilitation program (CRP) , diet education, physical exercise education, and taking Statin medications.
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Control group
Active
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Outcomes
Primary outcome [1]
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Serum lipid profile (Total cholesterol, Triglyceride, High desirable lipoprotien (HDL)
and Low desirable lipoprotien (LDL)). It is a composite primary outcome.
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Assessment method [1]
307757
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Timepoint [1]
307757
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Day 0 as baseline data and day 30 as endpoint
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Primary outcome [2]
307758
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Serum fasting glucose
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Assessment method [2]
307758
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Timepoint [2]
307758
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Day 0 as baseline data and day 30 as endpoint
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Secondary outcome [1]
352803
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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.
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Assessment method [1]
352803
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Timepoint [1]
352803
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Day 0 as baseline data and day 30 as endpoint
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Secondary outcome [2]
352804
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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.
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Assessment method [2]
352804
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Timepoint [2]
352804
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Day 0 as baseline data and day 30 as endpoint
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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
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Minimum age
20
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. ACS patients with renal failure
2. ACS patients with liver failure
3. ACS patients with pregnancy
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence number
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
None
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
1. Independence t test
2. Paired t test
3. Chi Square
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/03/2018
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Date of last participant enrolment
Anticipated
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Actual
9/03/2018
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Date of last data collection
Anticipated
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Actual
23/05/2018
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Sample size
Target
80
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Accrual to date
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Final
70
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Recruitment outside Australia
Country [1]
20933
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Malaysia
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State/province [1]
20933
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Wilayah Persekutuan Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
300913
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Government body
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Name [1]
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MALAYSIA MINISTRY OF SCIENCE, INNOVATION AND TECHNOLOGY
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Address [1]
300913
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MINISTRY OF SCIENCE AND TECHNOLOGY (MOSTI)
LEVEL 4, BLOCK C4, COMPLEX C
62662 PUTRAJAYA
MALAYSIA
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Country [1]
300913
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Malaysia
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Primary sponsor type
Government body
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Name
MALAYSIA MINISTRY OF SCIENCE,INNOVATION AND TECHNOLOGY
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Address
MINISTRY OF SCIENCE AND TECHNOLOGY (MOSTI)
LEVEL 4, BLOCK C4, COMPLEX C
62662 PUTRAJAYA
MALAYSIA
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Country
Malaysia
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Secondary sponsor category [1]
300511
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Other Collaborative groups
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Name [1]
300511
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BIORICH MARKETING
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Address [1]
300511
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Jalan Ppsl 1, Pusat Perniagaan Sungai Lias,
45300 Sungai Besar, Selangor
MALAYSIA
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Country [1]
300511
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Malaysia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301681
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RESEARCH ETHIC COMMITTEE UNIVERSITY OF MALAYA
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Ethics committee address [1]
301681
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Research ethic Committee
University of Malaya,
50603 Kuala Lumpur
MALAYSIA
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Ethics committee country [1]
301681
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Malaysia
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Date submitted for ethics approval [1]
301681
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19/07/2017
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Approval date [1]
301681
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08/08/2017
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Ethics approval number [1]
301681
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2017528-5276
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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.
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Trial website
none
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Trial related presentations / publications
none
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Public notes
none
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Attachments [1]
3154
3154
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/AnzctrAttachments/376178-Ethic approval.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
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Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
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Address
87770
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NURSING DEPARTMENT FACULTY OF MEDICINE,
UNIVERSITY OF MALAYA 50603
KUALA LUMPUR
MALAYSIA
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Country
87770
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Malaysia
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Phone
87770
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+60132851116
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Fax
87770
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Email
87770
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[email protected]
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Contact person for public queries
Name
87771
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Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
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Address
87771
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NURSING DEPARTMENT FACULTY OF MEDICINE,
UNIVERSITY OF MALAYA 50603
KUALA LUMPUR
MALAYSIA
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Country
87771
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Malaysia
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Phone
87771
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0132851116
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Fax
87771
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Email
87771
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[email protected]
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Contact person for scientific queries
Name
87772
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Ms SHARIFAH SHAFINAZ BINTI SH ABDULLAH
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Address
87772
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NURSING DEPARTMENT FACULTY OF MEDICINE,
UNIVERSITY OF MALAYA 50603
KUALA LUMPUR
MALAYSIA
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Country
87772
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Malaysia
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Phone
87772
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+60132851116
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Fax
87772
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Email
87772
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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