Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001111763
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
3/10/2013
Date last updated
27/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of fat free mass in older adults: a comparison of body composition methods in an Asian and European population
Scientific title
Validation of Bioelectrical Impedance Spectroscopy [BIS] for assessment of fat free mass in a Chinese Asian and European Caucasian adult population: comparison with dual energy x-ray absorptiometry (DeXA)
Secondary ID [1] 283348 0
none
Universal Trial Number (UTN)
Trial acronym
VALBIO_Asia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assessment of fat free mass 290242 0
Condition category
Condition code
Musculoskeletal 290634 290634 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
0
Target follow-up type
Weeks
Description of intervention(s) / exposure
Participants will undertake tests and measurements with 3 BIA/BIS devices (DF50, SFB7, SFB7mini prototype), DeXA, and pQCT.
All the measurements will be taken on one occassion
The approximated time is 1 hour to 1hr 15min
Intervention code [1] 288069 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290644 0
Fat free mass (FFM) assessed by BIA/BIS, DeXA and pQCT.
Timepoint [1] 290644 0
Baseline
Secondary outcome [1] 304969 0
Fat mass (FM) assessed by BIA/BIS, DeXA and pQCT.
Timepoint [1] 304969 0
Baseline

Eligibility
Key inclusion criteria
- Asian (Ethnic Chinese, mainland China, Hong Kong, Taiwanese), and
- Caucasian (Ethnic European)
- adult men and women; n=100 men, n=100 women; in both groups
- Aged 45-70 years
- 18-40kg/m2
- healthy, by self-report
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- significant current disease, including muscle wasting syndromes
- morbid obesity (BMI>40kg/m2)
- presence of a cardiac pacemaker
- pregnancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2013
Actual
7/10/2013
Date of last participant enrolment
Anticipated
Actual
6/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
407
Recruitment outside Australia
Country [1] 5458 0
New Zealand
State/province [1] 5458 0
Auckland

Funding & Sponsors
Funding source category [1] 288076 0
Commercial sector/Industry
Name [1] 288076 0
Fonterra Co-operative Group Ltd
Country [1] 288076 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Co-operative Group Ltd
Address
9 Princes Street
Private Bag 92032
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286800 0
None
Name [1] 286800 0
Address [1] 286800 0
Country [1] 286800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290003 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 290003 0
Health and Disability Ethics Committee, Ministry of Health, C/- MEDSAFE, Level 6, Deloitte House, 10 Brandon Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 290003 0
New Zealand
Date submitted for ethics approval [1] 290003 0
Approval date [1] 290003 0
06/09/2013
Ethics approval number [1] 290003 0
13/NTA/142

Summary
Brief summary
Background: The assessment of body composition is important to identify individuals at risk of muscle loss. Commercial bioelectrical impedence monitors are widely available, but provide only an indirect measure of fat free mass based on algorithms derived in Caucasian populations.
Objective: The objective of this study is to derive population specific predictive algorithms for the calculation of fat free mass and fat mass using a simple assessment device.
Design: This is a cross-sectional study, 400 participants, aged 45-70 years, of Asian Chinese (n=200) or Caucasian European (n=200) ethnicity will be recruited. Fat free mass (FFM) and fat mass (FM) will be measured on a single occasion using 3 BIA/BIS devices, DeXA and pQCT.
Findings: The findings from the study will enable rapid assessment of fat free mass in different target populations.
Trial website
Trial related presentations / publications
Final report sent to sponsor and participants
Public notes

Contacts
Principal investigator
Name 43430 0
Prof Sally Poppitt
Address 43430 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 43430 0
New Zealand
Phone 43430 0
+64 9 630 5160
Fax 43430 0
Email 43430 0
[email protected]
Contact person for public queries
Name 43431 0
Mr Wilson Yip
Address 43431 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 43431 0
New Zealand
Phone 43431 0
+64 9 630 3744
Fax 43431 0
Email 43431 0
[email protected]
Contact person for scientific queries
Name 43432 0
Prof Sally D Poppitt
Address 43432 0
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 43432 0
New Zealand
Phone 43432 0
+64 9 630 5160
Fax 43432 0
Email 43432 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
No additional documents have been identified.