- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870259
Investigating Physiological Adaptations to Weight Loss
December 3, 2014 updated by: Priya Sumithran, University of Melbourne
An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3081
- Heidelberg Repatriation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
2, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
Time Frame: week 8 vs week 10
|
week 8 vs week 10
|
|
Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
Time Frame: 0, 2, 6 and 12 months
|
0, 2, 6 and 12 months
|
|
Association of psychosocial factors with successful weight maintenance
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
March 26, 2009
First Submitted That Met QC Criteria
March 26, 2009
First Posted (ESTIMATE)
March 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 5, 2014
Last Update Submitted That Met QC Criteria
December 3, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP 508920
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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