Investigating Physiological Adaptations to Weight Loss

December 3, 2014 updated by: Priya Sumithran, University of Melbourne

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.

Study Overview

Status

Completed

Conditions

Obesity

Intervention / Treatment

Dietary supplement: Optifast VLCD

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - Melbourne, Victoria, Australia, 3081
    - Heidelberg Repatriation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	2, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state Time Frame: week 8 vs week 10	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	0, 2, 6 and 12 months
Association of psychosocial factors with successful weight maintenance Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)