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
Not applicable
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
Not applicable
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
The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.
Trial website
https://clinicaltrials.gov/study/NCT00870259
Trial related presentations / publications
Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00870259