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
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
Trial website
Trial related presentations / publications
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
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
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.