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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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

Study type
Description of intervention(s) / exposure
Other interventions - Optifast VLCD

Other interventions: Optifast VLCD
Meal replacement, three times daily for 8 weeks

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- major comorbid medial condition (including diabetes)

- taking medications known to affect weight

- smoking

Study design
Purpose of the study
Basic Science
Allocation to intervention
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Heidelberg Repatriation Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3081 - Melbourne

Funding & Sponsors
Primary sponsor type
University of Melbourne

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Other publications