NCT05365685

Brief Summary

The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

March 29, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

July 10, 2025

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 29, 2022

Last Update Submit

July 9, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Energy intake measured during an ad libitum buffet meal (in kcal).

    food intake will be measured ad libitum during a dinner buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using a nutritional software.

    it will be assessed at dinner baseline

Secondary Outcomes (2)

  • Hunger feelings

    immediately after breakfast/lunch/dinner on day 1

  • Food reward

    it will be assessed at dinner baseline

Study Arms (1)

adolescents with obesity

EXPERIMENTAL

There is only one arm as this is an acute randomized study comparing three different conditions within the same sample of participants.

Behavioral: Low energy turnover

Interventions

Low energy turnoverBEHAVIORAL

Low Energy Turnover. The adolescents with ingest low energy intake at lunch and breakfast and will not perform physical exercise during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals. Moderate Energy Turnover. The adolescents with ingest moderate energy intake at lunch and breakfast and will perform one 45 minutes physical exercise during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals. High Energy Turnover. The adolescents with ingest high energy intake at lunch and breakfast and will perform two 45-minute physical exercises during the day. The will will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Also known as: Moderate energy turnover, High energy turnover
adolescents with obesity

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • BMI percentile \> 97th percentile according to the french curves.
  • ages 12-16 years old
  • Signed consent form
  • being registered in the national social security system
  • no contraindication to physical activity

You may not qualify if:

  • Previous surgical interventions that is considered as non-compatible with the study.
  • Diabetes
  • weight loss during the last 6 months
  • cardiovascular disease or risks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

Related Publications (1)

  • Moore H, Pereira B, Fillon A, Miguet M, Masurier J, Beaulieu K, Finlayson G, Thivel D. The association between obesity severity and food reward in adolescents with obesity: a one-stage individual participant data meta-analysis. Eur J Nutr. 2024 Jun;63(4):1241-1255. doi: 10.1007/s00394-024-03348-4. Epub 2024 Feb 20.

    PMID: 38376518DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yves BOIRIE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

May 9, 2022

Study Start

August 27, 2022

Primary Completion

October 29, 2022

Study Completion

November 8, 2023

Last Updated

July 10, 2025

Record last verified: 2022-03

Locations

FR(1)