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Investigating Physiological Adaptations to Weight Loss

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 27, 2009
Last Update Posted: December 5, 2014
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.
Information provided by (Responsible Party):
Priya Sumithran, University of Melbourne
March 26, 2009
March 27, 2009
December 5, 2014
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 ]
Same as current
Complete list of historical versions of study NCT00870259 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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.
December 2009
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
HP 508920
Not Provided
Not Provided
Priya Sumithran, University of Melbourne
University of Melbourne
Not Provided
Not Provided
University of Melbourne
December 2014

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