NCT01015508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

November 17, 2009

Last Update Submit

October 24, 2012

Conditions

Obesity

Keywords

Weight loss and maintenancebody compositionenergy expenditureadipogenic capacityphysical activity

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

    0, 2 and 12 months

Secondary Outcomes (1)

  • Adipogenic capacity, Physical activity and body composition

    0, 2 and 12 months

Study Arms (3)

High predisposition

OTHER

High predisposition for weight regain

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

low predisposition

OTHER

low predisposition for weight regain

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

Medium predisposition

OTHER

Medium predisposition for weight regain

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

Interventions

Very Low Energy Diet (VLED)OTHER

a VLED (Modifast) for 2 months in order to reduce body weight

Also known as: Modifast
High predispositionMedium predispositionlow predisposition
Weight maintenanceOTHER

10 months

High predispositionMedium predispositionlow predisposition

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Human Biology (Maastricht University)

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (5)

  • Camps SG, Verhoef SP, Roumans N, Bouwman FG, Mariman EC, Westerterp KR. Weight loss-induced changes in adipose tissue proteins associated with fatty acid and glucose metabolism correlate with adaptations in energy expenditure. Nutr Metab (Lond). 2015 Oct 24;12:37. doi: 10.1186/s12986-015-0034-1. eCollection 2015.

    PMID: 26500687DERIVED

  • Camps SG, Verhoef SP, Westerterp KR. Weight loss-induced reduction in physical activity recovers during weight maintenance. Am J Clin Nutr. 2013 Oct;98(4):917-23. doi: 10.3945/ajcn.113.062935. Epub 2013 Aug 28.

    PMID: 23985804DERIVED

  • Verhoef SP, Camps SG, Gonnissen HK, Westerterp KR, Westerterp-Plantenga MS. Concomitant changes in sleep duration and body weight and body composition during weight loss and 3-mo weight maintenance. Am J Clin Nutr. 2013 Jul;98(1):25-31. doi: 10.3945/ajcn.112.054650. Epub 2013 May 22.

    PMID: 23697706DERIVED

  • Camps SG, Verhoef SP, Westerterp KR. Weight loss, weight maintenance, and adaptive thermogenesis. Am J Clin Nutr. 2013 May;97(5):990-4. doi: 10.3945/ajcn.112.050310. Epub 2013 Mar 27.

    PMID: 23535105DERIVED

  • Verhoef SP, Camps SG, Bouwman FG, Mariman EC, Westerterp KR. Physiological response of adipocytes to weight loss and maintenance. PLoS One. 2013;8(3):e58011. doi: 10.1371/journal.pone.0058011. Epub 2013 Mar 7.

    PMID: 23505452DERIVED

MeSH Terms

Conditions

ObesityWeight LossMotor Activity

Interventions

Body Weight Maintenance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Body WeightBody SizeGrowthGrowth and DevelopmentPhysiological Phenomena

Study Officials

  • Klaas R Westerterp, Prof

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

February 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

NL(1)