Adipogenic Capacity as a Mediator of Weight Gain

October 24, 2012 updated by: Maastricht University Medical Center

The Role of the Genetic Background Involved in Weight Regain Through Mechanisms Including Energy Expenditure, Physical Activity and Adipogenic Capacity

To demonstrate differences in response of subjects with a high, low or medium predisposition for weight regain after weight reduction in terms of: body composition; energy expenditure; physical activity; and adipogenic capacity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The risk for weight regain after weight loss is a major problem for the current obesity treatments, and is largely genetically determined. It is believed that an elucidation of the genetic component in the prognosis of weight management could assist in the development of more effective and individually tailored treatments. However, current research on the genetic component of weight management, and in particular weight regain, is still limited and data available are sometimes inconsistent. The current research proposal aims to identify groups with a high, low or medium predisposition for weight regain, based on a genetic profile and to demonstrate differences in the response of these subjects to a weight maintenance period after weight reduction in terms of body composition, physical activity, adipogenic capacity and energy expenditure.

Study Type

Interventional

Enrollment (Anticipated)

200

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

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • Dept. of Human Biology (Maastricht University)

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 to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 28-35
  • healthy, no medication
  • no smoking
  • stable weight (no weight loss/gain > 5kg in 3 months prior to study)

Exclusion Criteria:

  • 28< BMI >35
  • use of medication
  • smoking
  • weight loss/gain > 5kg in 3 months prior to study

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: High predisposition
High predisposition for weight regain
Other: Very Low Energy Diet (VLED)
a VLED (Modifast) for 2 months in order to reduce body weight
Other Names:
  • Modifast
Other: Weight maintenance
10 months
Other: low predisposition
low predisposition for weight regain
Other: Very Low Energy Diet (VLED)
a VLED (Modifast) for 2 months in order to reduce body weight
Other Names:
  • Modifast
Other: Weight maintenance
10 months
Other: Medium predisposition
Medium predisposition for weight regain
Other: Very Low Energy Diet (VLED)
a VLED (Modifast) for 2 months in order to reduce body weight
Other Names:
  • Modifast
Other: Weight maintenance
10 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Energy expenditure
Time Frame: 0, 2 and 12 months
0, 2 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adipogenic capacity, Physical activity and body composition
Time Frame: 0, 2 and 12 months
0, 2 and 12 months

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Klaas R Westerterp, Prof, Maastricht University

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

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, 2010

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HumBio_Westerterp09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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