NCT07844330

Brief Summary

Primarily over the past 20 years, it has been shown that physical activity not only leads to energy expenditure but can also indirectly influence energy intake and feelings of hunger in both lean and obese adults, suggesting that physical activity has a dual effect on energy balance. Studies in children and adolescents are less common, but it now seems clear that their energy intake is affected by physical exercise ) depending on their weight status.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Sep 2029

Study Start

First participant enrolled

September 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1.8 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • ad libitum food intake in response to exercise

    Method: Meta-Max Indirect Calorimetry The following will be measured here: energy expenditure in kcal/min based on oxygen consumption, as well as fat and carbohydrate utilization based on the respiratory quotient (VCO2/VO2), in mg/min.

    3 months

Secondary Outcomes (2)

  • Feelings of hunger in response to exercise

    3 months

  • Hedonic response as measured by food liking and wanting

    3 months

Study Arms (1)

Intervention

OTHER

The participants in this study are adolescents with obesity (with a Body Mass Index above the 95th percentile on international growth charts).

Other: The participants in this study are adolescents with obesity (with a Body Mass Index above the 95th percentile on international growth charts)

Interventions

This study aims to understand how physical exercise performed at a specific intensity that promotes fat utilization (called LipoxMax) influences food intake, hunger, and food preferences in adolescents with obesity. Following an initial screening visit to verify eligibility criteria and assess dietary habits, participants undergo a measurement visit at Clermont-Ferrand University Hospital, which includes anthropometric assessments (height, weight, waist and hip circumferences), body composition measurements (body fat, muscle mass, bone structure), and a bicycle ergometer test to determine their LipoxMax intensity. The adolescents then undergo two experimental visits at the AME2P laboratory in Clermont-Ferrand, conducted in random order and spaced at least five days apart. At each visit, they arrive having fasted, consume a standardized breakfast, and then rest until 11:00 a.m. They then either rest for 40 minutes (control condition) or perform a 40-minute exercise session at LipoxMax.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Adolescents aged 12 to 16 (inclusive), at Tanner stage 3-5,
  • With obesity defined as a body mass index (BMI) above the 95th percentile according to international growth charts,
  • Adolescents enrolled in the social security system or an equivalent program,
  • Adolescents who have been informed and have provided written consent to participate in the study

You may not qualify if:

  • Refusal to participate in the study,
  • Refusal of consent by legal guardians,
  • Regular use of tobacco or alcohol,
  • Special dietary restrictions,
  • Participation in regular and intense physical and sports activities,
  • Medical or surgical history deemed by the investigator to be incompatible with the study,
  • Diabetes, or any other condition that limits the application of either strategy in the trial,
  • Adolescents currently following a calorie-restricted diet or a weight-loss program involving physical activity at the time of enrollment or within the past 6 months,
  • Taking medications that may interfere with the study results,
  • Adolescents with cardiovascular problems; this refers to participants with a history of cardiovascular and/or neurovascular disease, as well as those with cardiovascular and/or neurovascular risk factors (excluding obesity or being overweight),
  • Surgery within the previous 3 months,
  • Adolescents who are currently excluded from another study,
  • Pregnant or breastfeeding adolescents,
  • Adolescents under guardianship, conservatorship, or judicial protection,
  • Parents under conservatorship, guardianship, or judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire AME2P

Aubière, 63178, France

Location

MeSH Terms

Conditions

Weight GainWeight Loss

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations