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Adipogenic Capacity as a Mediator of Weight Gain

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ClinicalTrials.gov Identifier: NCT01015508
Recruitment Status : Unknown
Verified October 2012 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2009
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Obesity Other: Very Low Energy Diet (VLED) Other: Weight maintenance

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Role of the Genetic Background Involved in Weight Regain Through Mechanisms Including Energy Expenditure, Physical Activity and Adipogenic Capacity
Study Start Date : February 2010
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: Modifast
Other: Weight maintenance
10 months
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 Name: Modifast
Other: Weight maintenance
10 months
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 Name: Modifast
Other: Weight maintenance
10 months


Outcome Measures

Primary Outcome Measures :
  1. Energy expenditure [ Time Frame: 0, 2 and 12 months ]

Secondary Outcome Measures :
  1. Adipogenic capacity, Physical activity and body composition [ Time Frame: 0, 2 and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015508


Locations
Netherlands
Dept. of Human Biology (Maastricht University)
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Klaas R Westerterp, Prof Maastricht University
More Information