Overview

This trial is active, not recruiting.

Condition obesity
Treatments very low energy diet (vled), weight maintenance
Sponsor Maastricht University Medical Center
Start date February 2010
End date November 2012
Trial size 200 participants
Trial identifier NCT01015508, HumBio_Westerterp09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Other)
High predisposition for weight regain
very low energy diet (vled) Modifast
a VLED (Modifast) for 2 months in order to reduce body weight
weight maintenance
10 months
(Other)
low predisposition for weight regain
very low energy diet (vled) Modifast
a VLED (Modifast) for 2 months in order to reduce body weight
weight maintenance
10 months
(Other)
Medium predisposition for weight regain
very low energy diet (vled) Modifast
a VLED (Modifast) for 2 months in order to reduce body weight
weight maintenance
10 months

Primary Outcomes

Measure
Energy expenditure
time frame: 0, 2 and 12 months

Secondary Outcomes

Measure
Adipogenic capacity, Physical activity and body composition
time frame: 0, 2 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title The Role of the Genetic Background Involved in Weight Regain Through Mechanisms Including Energy Expenditure, Physical Activity and Adipogenic Capacity
Principal investigator Klaas R Westerterp, Prof
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.