NCT06017440

Brief Summary

While long considered independently, energy expenditure and energy intake have been shown to interact. Fot the last 20 years, the litterature has been describing tyhe effects of an acute bout of exercise on subsequent energy intake and appetitive responses, indicating a potenital anorexigenic effect of intensive exercise in adolescents with obesity. These studies suggest a decrease in hunger, redcued satiety and modified food reward responses. These results remain however obtained in studies using post exercise ad libitum test meals and this nature of the meal might ahve impact these responses. The present work tends to assess the effect of acute exercise on subsequent appetite and food reward responses to a fixed meal, in adolescents with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

June 13, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • APPETITE FEELINGS

    appetite sensation will be assessed using visual analog scales

    immediately after lunch

  • FOOD reward

    food reward will be assessed using the leeds food preference questionnaire

    at lunch time

  • Energy intake

    energy intake will be assessed ad libitum at the following diner

    at lunch time

Study Arms (1)

adolescents with obesity

EXPERIMENTAL

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

Behavioral: EXERCISEBehavioral: CONTROL

Interventions

EXERCISEBEHAVIORAL

Participants will receive at 08:00 am a calibrated breakfast of 500kcal. They should not perform physical exercise during the day. They will be asked at 11 a.m. to cycle for 30 minutes at 65% of the maximal capacities and their energy expenditure will be measured by indirect calorimetry. At 11 a.m., teenagers will receive a calibrated meal of 800 kcal respecting the nutritional recommendations for this age. Questionnaires on feelings of hunger will be distributed to them at regular intervals. They will also be asked to complete a 10-minute computer exercise to assess their relationship to food before and after lunch (LFPQ. Leeds Food Preference Questionnaire, Liking/ wanting). Finally, from 60 minutes after the midday test meal, teenagers will have access to an ad libitum buffet for one hour.

adolescents with obesity
CONTROLBEHAVIORAL

Teenagers should not perform any physical activity during the day and they will be asked to stay at 11 a.m., for 30 minutes, resting in a semi-supine position.

adolescents with obesity

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects aged 11 to 16 years (inclusive limits), maturation stage 3-5 according to the Tanner classification, with obesity defined by a body mass index (BMI) greater than the 97th percentile according to national curves (Roland- Cachera et al., 1991).
  • Adolescent who has signed the information and consent form and whose holders of parental authority have signed the information and consent form
  • Person subject to a Social Security scheme

You may not qualify if:

  • Medical or surgical history deemed by the investigator to be incompatible with the study
  • Presence of diabetes, and any other pathology limiting the application of one or the other strategy to the trial.
  • Taking medications that may interfere with the results of the study
  • Subjects with cardiovascular problems, here we are talking about subjects with a history of cardiovascular and/or neurovascular pathology, as well as subjects presenting cardiovascular and/or neurovascular risk factors (excluding obesity/ overweight).
  • Surgical intervention in the previous 3 months.
  • Consumption of tobacco or alcohol.
  • Special diet.
  • Participation in regular and intense physical and sports activities for more than two hours per week.
  • Teenagers whose parents are under guardianship, curatorship, safeguard of justice or not subject to a social security system
  • Refusal to sign the information and consent notice
  • Pregnant or breastfeeding adolescents on declarative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yves Boirie

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 13, 2023

First Posted

August 30, 2023

Study Start

July 1, 2023

Primary Completion

September 17, 2023

Study Completion

October 17, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations