Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000579291
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
16/04/2018
Date last updated
19/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating Effects of Genetic Variants and Lifestyle on The Risk of Developing Obesity in Healthy Indonesian Subjects
Scientific title
FTO and CD36 Risk Variants Association with Visceral Obesity and Fat Consumption in Indonesian
Secondary ID [1] 294429 0
None
Universal Trial Number (UTN)
U1111-1211-3012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 307179 0
Condition category
Condition code
Diet and Nutrition 306293 306293 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Female and male were involved in this cross-sectional study. CD36 rs1761667 and FTO rs9939609 genotypes were identified from blood using PCR-RFLP; and then, were compared with dietary patterns, physical activities, medical data, and body compositions.

The subjects had to undergo body composition measurement and the medical checkup procedure before participating in this study. Subject’s body composition was analyzed using InBody720 (Biospace, Gangnam-gu, Seoul, Korea) which was based on bioelectrical impedance method. The instrument predicts the body fat mass and non-fat mass by measuring total water value and low electric current resistance within the human body. Other body compositions such as body mass index (BMI), waist-hip ratio (WHR), percent body fat (PBF), visceral fat area (VFA), and basal metabolic rate (BMR) were also analyzed using this instrument. The medical data collected from subjects were total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride, blood glucose, systolic and diastolic blood pressure.

To investigate subjects’ nutrient intake in the last 24 hours, all subjects were interviewed using 24-hour food recall. Subjects were required to memorize the type and amount of foods and drinks they had consumed for the last 24 hours; and informed them to the interviewer. Food models were used as visual aid for facilitating this procedure. The 24-hour food recall was performed three times; twice on the weekdays and once on the weekend. The 24-hour food recall data were further processed using Food Processor SQL 10.1.1; ESHA, Salem, Oregon to generate detailed nutrient intake information.

International Physical Activity Questionnaire (IPAQ) was used to analyze the activity level. This questionnaire calculated the physical activity Metabolic equivalents (METs) value taken for the past week. The physical activity METS were calculated based on the intensity and duration of an activity. METs are described as the amount of oxygen consumed when sitting at rest.

Two milliliter of blood samples were collected from each subject after 8 hours of fasting.
Intervention code [1] 300726 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305297 0
Body fat percentage as measured by bio-electrical impedance analysis
Timepoint [1] 305297 0
Baseline
Primary outcome [2] 305298 0
Dietary pattern as measured by 24-hour food recall
Timepoint [2] 305298 0
Baseline
Primary outcome [3] 305340 0
FTO genotype as assessed by PCR-RFLP
Timepoint [3] 305340 0
Baseline
Secondary outcome [1] 344779 0
Waist-hip ratio assessed by InBody 720 bio-electrical impedance analysis which uses its impedance index to provide a scientific estimation of the subject’s ratio of abdominal fat and WHR
Timepoint [1] 344779 0
Baseline
Secondary outcome [2] 344780 0
Waist circumference assessed by tape measure
Timepoint [2] 344780 0
Baseline
Secondary outcome [3] 344781 0
Metabolic profile assessed using patients' medical records, such as total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride, blood glucose, systolic and diastolic blood pressure.
Timepoint [3] 344781 0
Baseline
Secondary outcome [4] 344782 0
Visceral fat assessed by bio-electrical impedance analysis
Timepoint [4] 344782 0
Baseline
Secondary outcome [5] 344900 0
BMI assessed by bio-electrical impedance analysis
Timepoint [5] 344900 0
Baseline
Secondary outcome [6] 344901 0
Activity level/METs assessed by International Physical Activity Questionnaires
Timepoint [6] 344901 0
Baseline
Secondary outcome [7] 344902 0
Basal metabolic rate assessed by bio-electrical impedance analysis
Timepoint [7] 344902 0
Baseline
Secondary outcome [8] 344903 0
Cholesterol assessed using patients' medical records
Timepoint [8] 344903 0
Baseline
Secondary outcome [9] 344904 0
Triglyceride assessed using patients' medical records
Timepoint [9] 344904 0
Baseline
Secondary outcome [10] 344905 0
Blood glucose assessed using patients' medical records
Timepoint [10] 344905 0
Baseline
Secondary outcome [11] 344906 0
Blood pressure assessed using patients' medical records
Timepoint [11] 344906 0
Baseline

Eligibility
Key inclusion criteria
This study involved females and males who were selected
based on the following criteria: aged between 20-30 years old, did not suffer any
chronic diseases or fever, did not smoke, did not drink alcohol frequently (five times or
more in the past month), did not take any medication or treatment, not being pregnant
and not breastfeeding.
Minimum age
20 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The list of exclusion criteria in this study:
1. Individuals who are not able to provide reliable data and adhere to procedures,
2. Subjects with history of diabetes, cardiovascular, respiratory, hepatic, renal,
gastrointestinal, neurological or infectious disorders.
3 Subjects recovering from a certain treatment.
4. Regular alcohol intake greater than 28 units*/week (male), or 21 units/week (female) (* 1 unit = 8 g ethanol, ¼ liter of beer or 1 glass wine or 1 measure of spirits.
5. Positive HIV serology.
6. Positive hepatitis B or hepatitis C serology.
7. Any drug intake which may interfere with the results of the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Statistical analyses were performed with SPSS Statistics 21 (IBM, Armonk, New
York, United States). The mean difference between groups was analyzed using
Student’s t-test or Mann-Whitney test. All P values reported in this study were two-tailed
and P less than 0.05 were considered statistically significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
7/01/2017
Date of last participant enrolment
Anticipated
Actual
13/01/2017
Date of last data collection
Anticipated
Actual
24/03/2017
Sample size
Target
50
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 10239 0
Indonesia
State/province [1] 10239 0
Jakarta

Funding & Sponsors
Funding source category [1] 299059 0
Commercial sector/Industry
Name [1] 299059 0
Nutrifood Research Center, PT Nutrifood Indonesia.
Country [1] 299059 0
Indonesia
Primary sponsor type
Commercial sector/Industry
Name
Nutrifood Research Center, PT Nutrifood Indonesia.
Address
Nutrifood Research Center, PT Nutrifood Indonesia.
Kawasan Industri Pulogadung Jalan. Rawabali II No.3. Jakarta, 13920, Indonesia.
Country
Indonesia
Secondary sponsor category [1] 298331 0
None
Name [1] 298331 0
Address [1] 298331 0
Country [1] 298331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299992 0
Ethical Commissions of Atma Jaya Catholic University of Indonesia.
Ethics committee address [1] 299992 0
Ethics committee country [1] 299992 0
Indonesia
Date submitted for ethics approval [1] 299992 0
28/11/2016
Approval date [1] 299992 0
07/12/2016
Ethics approval number [1] 299992 0
1468/III/LPPM-PM. 10.05/09/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82194 0
Mr Stephen Salim
Address 82194 0
Atma Jaya Catholic University of Indonesia
Jl. Jenderal Sudirman 51, Jakarta 12930
Country 82194 0
Indonesia
Phone 82194 0
+62 815 961 2249
Fax 82194 0
Email 82194 0
[email protected]
Contact person for public queries
Name 82195 0
Stephen Salim
Address 82195 0
Atma Jaya Catholic University of Indonesia
Jl. Jenderal Sudirman 51, Jakarta 12930
Country 82195 0
Indonesia
Phone 82195 0
+62 815 961 2249
Fax 82195 0
Email 82195 0
[email protected]
Contact person for scientific queries
Name 82196 0
Stephen Salim
Address 82196 0
Atma Jaya Catholic University of Indonesia
Jl. Jenderal Sudirman 51, Jakarta 12930
Country 82196 0
Indonesia
Phone 82196 0
+62 815 961 2249
Fax 82196 0
Email 82196 0
[email protected]

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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssociation of fto rs9939609 and cd36 rs1761667 with visceral obesity.2020https://dx.doi.org/10.3177/jnsv.66.S329
N.B. These documents automatically identified may not have been verified by the study sponsor.