- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017440
Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity (SMASH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After an inclusion visit to ensure the aptitude of adolescents to complete the entire study, each will have to carry out densitometric measurements (body composition and bone structure). The adolescents will then carry out, in a randomized manner, 2 experimental sessions spaced at least 7 days apart: i) a control session (CON); ii) a session with a pedaling exercise at 65% of their estimated maximum capacity (EX).
During each of these experimental sessions, teenagers will receive a calibrated breakfast at 08:00 am. During the CON session, 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. During the EX session, teenagers will perform moderate-intensity physical exercise (65% of their estimated maximum capacity) at 11 a.m. At noon, the teenagers will have to consume a calibrated meal. 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 just before and just after the calibrated midday meal (LFPQ. Leeds Food Preference Questionnaire, Liking/Wanting, French version). Sixty minutes after the calibrated meal, teenagers will have an ad libitum buffet available for one hour.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France
- CHU de Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
- Subjects undergoing energy restriction or weight loss program through physical activity at the time of inclusion or during the last six 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
- Person in period of exclusion from another study
- Pregnant or breastfeeding adolescents on declarative
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: adolescents with obesity
There is only one arm as this is an acute randomized study comparing two differents conditions within the same sample of participants.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
APPETITE FEELINGS
Time Frame: immediately after lunch
|
appetite sensation will be assessed using visual analog scales
|
immediately after lunch
|
|
FOOD reward
Time Frame: at lunch time
|
food reward will be assessed using the leeds food preference questionnaire
|
at lunch time
|
|
Energy intake
Time Frame: at lunch time
|
energy intake will be assessed ad libitum at the following diner
|
at lunch time
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yves Boirie, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2023 BOIRIE 3
- 2023-A00808-37 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise
-
Centre Hospitalier de CorbieRecruitingExercise Training | Cardiac Rehabilitation | Exercise Intolerance | Exercise Intervention | Exercise Adaptations | HFrEF - Heart Failure With Reduced Ejection FractionFrance
-
Bitlis Eren UniversityCompletedExercise Physiology | Exercise ImmunologyTurkey (Türkiye)
-
Hamza KucukCompletedExercise Training | Exercise PhysiologyTurkey (Türkiye)
-
Faculdade de Motricidade HumanaCompletedGreen Exercise | Indoor ExercisePortugal
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompletedAgeing | Aerobic Exercise | Resistance Exercise | Combined ExercisePortugal
-
Lindenwood UniversityIncrenovo, LLCRecruitingCognitive Function | Blood Flow | Nitric Oxide | Endurance Exercise | Exercise Performance | Exercise RecoveryUnited States
-
Universidad Rey Juan CarlosCompletedEndurance Exercise | Running Performance | Exercise PhysiologySpain
-
Istanbul Sabahattin Zaim UniversityT.C. Dumlupınar ÜniversitesiCompletedExercise Ergogenics | Recovery Methods | Carnitine Ingestion | Exercise Fatigue | Exercise and RecoveryTurkey (Türkiye)
-
Hasan Kalyoncu UniversityNot yet recruiting
-
University of HawaiiKlein Buendel, Inc.CompletedMomZing Exercise Videos Online | Standard Exercise DVDUnited States
Clinical Trials on EXERCISE
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
University of Missouri-ColumbiaCompleted
-
University of AlcalaCompletedMyofascial Pain | Myofascial Pain Syndrome | Post Needling Soreness | Myofascial Trigger Point PainSpain
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Bayero University Kano, NigeriaCompletedChronic Low Back PainNigeria
-
University College CorkRecruitingDepressive Disorder, MajorIreland