Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000643673
Ethics application status
Approved
Date submitted
10/06/2014
Date registered
18/06/2014
Date last updated
18/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Normative anthropometric, body composition, bone health and energy expenditure in Singaporean adults
Scientific title
A cross-sectional study to examine the anthropometric, body composition, bone health and energy expenditure in Singaporean adults
Secondary ID [1] 284762 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 292133 0
Condition category
Condition code
Diet and Nutrition 292466 292466 0 0
Obesity
Public Health 292512 292512 0 0
Other public health
Metabolic and Endocrine 292513 292513 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be a cross-sectional study. All participants will be asked to attend a testing session, where their anthropometric indices, body composition, bone health (optional), energy expenditure and blood profile (optional) will be collected at a single time point. The testing session will last a maximum of 2 hours and 20 minutes.
Intervention code [1] 289556 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292328 0
Composite primary outcome: Anthropometric indices including height (stadiometer), weight (Tanita BC-418), skinfolds (Holtain skinfold calipers) circumferences (Lufkin PM606 anthropometric tape), lengths (segmometer), and breadths (sliding caliper).
Timepoint [1] 292328 0
At baseline
Secondary outcome [1] 308721 0
Body composition such as fat mass, fat free mass, and total mass will be measured using BODPOD Body Composition Tracking System and dual energy x-ray absorptiometry (DEXA).
Timepoint [1] 308721 0
At baseline
Secondary outcome [2] 308722 0
Bone health such as bone mineral density and bone mineral content will be measured using DEXA scan (optional).
Timepoint [2] 308722 0
At baseline
Secondary outcome [3] 308723 0
Basal metabolic rate will be measured via indirect calorimetry using a ventilated hood system with the participant resting supine following a 10 hour overnight fast.
Timepoint [3] 308723 0
At baseline
Secondary outcome [4] 308726 0
Fasting blood glucose concentration will be measured by finger-prick method using the Hemocue. A venous blood sample will be collected to measure insulin and lipid profile using the COBAS 4000 analysers (optional).
Timepoint [4] 308726 0
At baseline

Eligibility
Key inclusion criteria
Overtly healthy adults, defined as individuals who are not taking medications regularly and have not been diagnosed with any major disease.
Minimum age
21 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
As this is an ongoing study aiming to provide a comprehensive reference data set, no power calculation can be provided. Participants' characteristics will be presented as arithmetic means and standard deviations. Categorical data will be presented as frequencies and percentages.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/06/2014
Date of last participant enrolment
Anticipated
16/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 6110 0
Singapore
State/province [1] 6110 0

Funding & Sponsors
Funding source category [1] 289379 0
Government body
Name [1] 289379 0
Singapore Institute for Clinical Sciences, A*STAR
Country [1] 289379 0
Singapore
Primary sponsor type
Government body
Name
Singapore Institute for Clinical Sciences, A*STAR
Address
Brenner Centre for Molecular Medicine
30 Medical Drive
Singapore 117609
Country
Singapore
Secondary sponsor category [1] 288065 0
None
Name [1] 288065 0
Address [1] 288065 0
Country [1] 288065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291143 0
Singapore National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 291143 0
3 Fusionopolis Link
#03-08 Nexus@one-north
Singapore 138543
Ethics committee country [1] 291143 0
Singapore
Date submitted for ethics approval [1] 291143 0
Approval date [1] 291143 0
24/04/2014
Ethics approval number [1] 291143 0
2013/00783

Summary
Brief summary
Reference data can be used in clinical settings to monitor the growth of individuals and to identify those at risk for under or over-nutrition and assess their response to treatment. Reference data can come from either local or international sources. Local reference data should be compiled from measurements made on healthy, well nourished individuals. The group should be ethnically and genetically representative of the population to be investigated. Such data should be used when ethnic and genetic factors influence growth potential are predominant. Singapore is a multiethnic country, primarily comprised of people who are of Chinese, Malay and Indian ethnicity, and thus it is imperative that reference datasets represent the dominant races. The differences in anthropometric, body composition, bone health, and basal metabolic rate between Asians and Caucasians have been well documented. However, comparisons between the ethnic majorities in Singapore are scarce. With the use of a Singaporean reference dataset, ethnic specific tools to assess nutritional status could be developed for use in clinical practice. Therefore, the aim of this study is to create a "normative" / "reference" database on anthropometric indices, body composition, bone health, and basal metabolic rate in Singaporean adults of Chinese, Malay or Indian origin. The database will act as a reference point for clinicians and researchers in order to determine whether or not subject results are within “normal ranges” for their age and sex. It can also be used to establish ethnic specific indices of health risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49082 0
Dr Agnes Siew Ling Tey
Address 49082 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 49082 0
Singapore
Phone 49082 0
+65 6407 0741
Fax 49082 0
+65 6774 7134
Email 49082 0
[email protected]
Contact person for public queries
Name 49083 0
Dr Agnes Siew Ling Tey
Address 49083 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 49083 0
Singapore
Phone 49083 0
+65 6407 0741
Fax 49083 0
+65 6774 7134
Email 49083 0
[email protected]
Contact person for scientific queries
Name 49084 0
Dr Agnes Siew Ling Tey
Address 49084 0
14 Medical Drive #07-02 Yong Loo Lin School of Medicine Singapore 117599
Country 49084 0
Singapore
Phone 49084 0
+65 6407 0741
Fax 49084 0
+65 6774 7134
Email 49084 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
EmbaseEstimation of basal metabolic rate in Chinese: Are the current prediction equations applicable?.2016https://dx.doi.org/10.1186/s12937-016-0197-2
N.B. These documents automatically identified may not have been verified by the study sponsor.