CONTROL ConditionSMASHNCT06017440
Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity
A study testing EXERCISE in people with CONTROL Condition and Exercise, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- CONTROL Condition, Exercise
- What is being tested?
- EXERCISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to 17 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- CONTROL Condition, Exercise
- Being tested
- EXERCISE, CONTROL
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISEBehavioural
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.
CONTROLBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EXERCISE; Behavioral: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
APPETITE FEELINGS
appetite sensation will be assessed using visual analog scales
Measured: immediately after lunch
FOOD reward
food reward will be assessed using the leeds food preference questionnaire
Measured: at lunch time
Energy intake
energy intake will be assessed ad libitum at the following diner
Measured: at lunch time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jul 2023
- Primary completion17 Sep 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CONTROL ConditionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017440
- Sponsor's protocol ID
- RBHP 2023 BOIRIE 3
- Other IDs
- 2023-A00808-37
- Acronym
- SMASH
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siroux J, Moore H, Isacco L, Couvert A, Pereira B, Julian V, Duclos M, Miyashita M, Finlayson G, Boirie Y, Thivel D. Acute exercise might not affect subsequent appetite responses to a fixed meal in adolescents with obesity: The SMASH exploratory study. Appetite. 2024 Nov 1;202:107644. doi: 10.1016/j.appet.2024.107644. Epub 2024 Aug 20.
PubMed 39173841
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT06017440
- Acronym / sponsor ID
- SMASH / RBHP 2023 BOIRIE 3
- Conditions
- CONTROL Condition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 17 Sep 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents with obesity | Experimental | Behavioral: EXERCISE, Behavioral: CONTROLThere is only one arm as this is an acute randomized study comparing two differents conditions within the same sample of participants. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISEParticipants 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. | Behavioural | adolescents with obesity |
| CONTROLTeenagers 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. | Behavioural | adolescents with obesity |
Primary outcome
APPETITE FEELINGS
Time frame: immediately after lunch
appetite sensation will be assessed using visual analog scales
FOOD reward
Time frame: at lunch time
food reward will be assessed using the leeds food preference questionnaire
Energy intake
Time frame: at lunch time
energy intake will be assessed ad libitum at the following diner
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 39173841Siroux J, Moore H, Isacco L, Couvert A, Pereira B, Julian V, Duclos M, Miyashita M, Finlayson G, Boirie Y, Thivel D. Acute exercise might not affect subsequent appetite responses to a fixed meal in adolescents with obesity: The SMASH exploratory study. Appetite. 2024 Nov 1;202:107644. doi: 10.1016/j.appet.2024.107644. Epub 2024 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Boirie principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE in people with CONTROL Condition and Exercise, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APPETITE FEELINGS (time frame: immediately after lunch). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06017440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.