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Investigating Physiological Adaptations to Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Melbourne.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00870259
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety [ Time Frame: 0, 2, 6 and 12 months ] [ Designated as safety issue: No ]
  • Association of psychosocial factors with successful weight maintenance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated 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
Genders Eligible for Study:   Both
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
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

No publications provided by University of Melbourne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Joseph Proietto, University of Melbourne
ClinicalTrials.gov Identifier: NCT00870259     History of Changes
Other Study ID Numbers: HP 508920
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Melbourne:
Weight loss
Weight maintenance

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013