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Investigating Physiological Adaptations to Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00870259
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Priya Sumithran, University of Melbourne

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Optifast VLCD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
Study Start Date : February 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Dietary Supplement: Optifast VLCD
    Meal replacement, three times daily for 8 weeks

Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state [ Time Frame: week 8 vs week 10 ]
  2. Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety [ Time Frame: 0, 2, 6 and 12 months ]
  3. Association of psychosocial factors with successful weight maintenance [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870259


Locations
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Australia, Victoria
Heidelberg Repatriation Hospital
Melbourne, Victoria, Australia, 3081
Sponsors and Collaborators
University of Melbourne
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Priya Sumithran, Clinical research fellow, University of Melbourne
ClinicalTrials.gov Identifier: NCT00870259    
Other Study ID Numbers: HP 508920
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Priya Sumithran, University of Melbourne:
Weight loss
Weight maintenance
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight