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

March 26, 2009
March 26, 2009
February 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Investigating Physiological Adaptations to Weight Loss
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Obesity
Dietary Supplement: Optifast VLCD
Meal replacement, three times daily for 8 weeks
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00870259
HP 508920
No
Professor Joseph Proietto, University of Melbourne
University of Melbourne
Not Provided
Not Provided
University of Melbourne
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP