Back to resultsInvestigating Physiological Adaptations to Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Optifast VLCD
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Weight loss, Weight maintenance
Eligibility Criteria
Inclusion Criteria:
- males and post-menopausal females
- aged over 18 years
- BMI 27-40kg/m2
- weight-stable
Exclusion Criteria:
- major comorbid medial condition (including diabetes)
- taking medications known to affect weight
- smoking
Sites / Locations
- Heidelberg Repatriation Hospital
Outcomes
Primary Outcome Measures
Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline
Secondary Outcome Measures
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
Association of psychosocial factors with successful weight maintenance
Full Information
NCT ID
NCT00870259
First Posted
March 26, 2009
Last Updated
December 3, 2014
Sponsor
University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT00870259
Brief Title
Investigating Physiological Adaptations to Weight Loss
Official Title
An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss, Weight maintenance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Optifast VLCD
Intervention Description
Meal replacement, three times daily for 8 weeks
Primary Outcome Measure Information:
Title
Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline
Time Frame
2, 6 and 12 months
Secondary Outcome Measure Information:
Title
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
Time Frame
week 8 vs week 10
Title
Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
Time Frame
0, 2, 6 and 12 months
Title
Association of psychosocial factors with successful weight maintenance
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
males and post-menopausal females
aged over 18 years
BMI 27-40kg/m2
weight-stable
Exclusion Criteria:
major comorbid medial condition (including diabetes)
taking medications known to affect weight
smoking
Facility Information:
Facility Name
Heidelberg Repatriation Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22029981
Citation
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.
Results Reference
derived
Learn more about this trial
Investigating Physiological Adaptations to Weight Loss
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