Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00870259




Registration number
NCT00870259
Ethics application status
Date submitted
26/03/2009
Date registered
27/03/2009
Date last updated
5/12/2014

Titles & IDs
Public title
Investigating Physiological Adaptations to Weight Loss
Scientific title
An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
Secondary ID [1] 0 0
HP 508920
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Optifast VLCD

Treatment: Other: Optifast VLCD
Meal replacement, three times daily for 8 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline
Timepoint [1] 0 0
2, 6 and 12 months
Secondary outcome [1] 0 0
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
Timepoint [1] 0 0
week 8 vs week 10
Secondary outcome [2] 0 0
Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
Timepoint [2] 0 0
0, 2, 6 and 12 months
Secondary outcome [3] 0 0
Association of psychosocial factors with successful weight maintenance
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
* males and post-menopausal females
* aged over 18 years
* BMI 27-40kg/m2
* weight-stable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* major comorbid medial condition (including diabetes)
* taking medications known to affect weight
* smoking

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Heidelberg Repatriation Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3081 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00870259