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Adipogenic Capacity as a Mediator of Weight Gain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01015508
First received: November 17, 2009
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Obesity
 Other: Very Low Energy Diet (VLED)
Other: Weight maintenance

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Energy expenditure [ Time Frame: 0, 2 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adipogenic capacity, Physical activity and body composition [ Time Frame: 0, 2 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01015508     History of Changes
Other Study ID Numbers: HumBio_Westerterp09
Study First Received: November 17, 2009
Last Updated: October 24, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Weight loss and maintenance
body composition
energy expenditure
adipogenic capacity
physical activity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013