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Investigating Physiological Adaptations to Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Priya Sumithran, University of Melbourne
ClinicalTrials.gov Identifier:
NCT00870259
First received: March 26, 2009
Last updated: December 3, 2014
Last verified: December 2014
  Purpose
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 Intervention
Obesity
Dietary Supplement: Optifast VLCD

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss

Resource links provided by NLM:


Further study details as provided by Priya Sumithran, University of Melbourne:

Primary Outcome Measures:
  • 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:
  • Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state [ Time Frame: 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 ]
  • Association of psychosocial factors with successful weight maintenance [ Time Frame: 12 months ]

Enrollment: 50
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Optifast VLCD
    Meal replacement, three times daily for 8 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870259

Locations
Australia, Victoria
Heidelberg Repatriation Hospital
Melbourne, Victoria, Australia, 3081
Sponsors and Collaborators
University of Melbourne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Priya Sumithran, Clinical research fellow, University of Melbourne
ClinicalTrials.gov Identifier: NCT00870259     History of Changes
Other Study ID Numbers: HP 508920
Study First Received: March 26, 2009
Last Updated: December 3, 2014

Keywords provided by Priya Sumithran, University of Melbourne:
Weight loss
Weight maintenance

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017