Investigating Physiological Adaptations to Weight Loss

Obesity Clinical Trial

Official title:

An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870259
• Other study ID #: HP 508920
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: December 3, 2014
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2014
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Optifast VLCD
Meal replacement, three times daily for 8 weeks

Locations

Country	Name	City	State
Australia	Heidelberg Repatriation Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline		2, 6 and 12 months	No
Secondary	Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state		week 8 vs week 10	No
Secondary	Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety		0, 2, 6 and 12 months	No
Secondary	Association of psychosocial factors with successful weight maintenance		12 months	No