Appetite ControlEXHALIMNCT05935072
Nutritional Responses to Acute Exercise: Test of the Influence of the Nature of the Meal:
A study testing Exercice and meal in people with Appetite Control and Exercise, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The management of body mass and energy balance requires a better understanding and mastery of the interactions between our daily activities, such as physical exercise, and the control of our food intake. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Control, Exercise
- What is being tested?
- Exercice and meal
- 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
- 15 Jul 2023to 15 Mar 2025
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male aged 18 to 30 (limits inclusive),
- with a body mass index between 20 and 25 kg.m².
- Able to give informed consent to participate in research
- 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 being tested.
- Subjects undergoing energy restriction or weight loss program through physical activity at the time of inclusion or during the last 6 months.
- Taking medications that may interfere with study results
- Claustrophobia
- 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).
Show all 16Show fewer
- Student or professional in the field of dietetics and nutrition
- Surgical intervention in the previous 3 months.
- Person under guardianship / curatorship or safeguard of justice
- Participant refusal to participate Person in period of exclusion from another study
- Tobacco use
- Alcohol consumption (more than 5 drinks per week).
- Special diet.
- Participation in regular and intense physical and sports activities (more than 90 minutes per week).
- Person refusing to be registered on the National File of Healthy Volunteers of the Ministry of Health,
- Subject in a period of exclusion from a previous study or having received a total amount of compensation greater than 6000 euros over the 12 months preceding the start of the trial (after verification in the Biomedical Research Volunteers File).
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Yves BOIRIE
About this study
Official title: Nutritional Responses to Acute Exercise: Test of the Influence of the Nature of the Meal: EXHALIM Study
The management of body mass and energy balance requires a better understanding and mastery of the interactions between our daily activities, such as physical exercise, and the control of our food intake.
Over the past 15 years, many studies have focused on the potential effects of physical exercise on this satiety cascade and on subsequent food intake, in many populations. Thus, both in normal-weight subjects and in patients suffering from overweight and obesity, it has been shown that the performance of an acute exercise of moderate intensity promotes a transient anorectic effect, reducing feelings of hunger post -exercise, and can even induce a reduction in subsequent food intake. In healthy young adults, recent results show that high-intensity physical exercise can reduce feelings of hunger and increase the satietogenic effect of a meal compared to a control condition and low-intensity exercise. intensity. Nevertheless, it seems that the food reward (which refers to the notion of food reward) does not respond in the same way, the authors not observing any change in either liking or wanting, regardless of exercise intensity. Importantly, this literature uses ad libitum test meals, wishing to assess both satietogenic, hedonic and purely nutritional responses (assessing the amount of food intake). Nevertheless, these sensory and hedonic responses to food intake have recently been shown to be sensitive to the composition of the meal and its caloric quantity, which could induce a significant bias as to the conclusions on the effects of physical exercise. Indeed, the use of meals ad libitum, by definition, leads to caloric intake and different meal compositions. Thus, it is possible that the results obtained are strongly impacted by the nature of the test meal more than by the exercise itself. It therefore remains uncertain today to conclude as to the effects of physical exercise on the factors of the satietogenic cascade, since beyond physical exercise, the test meals compared are not identical. It therefore seems important today to develop a more coherent and adapted methodology, to better study the food and satietogenic responses to our daily activities.
In this context, the present project aims to compare the satietogenic response to a meal following acute exercise according to the nature of this meal (ad libitum versus calibrated) in healthy adults.
- Conditions
- Appetite Control, Exercise
- Being tested
- Exercice and meal
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercice and mealBehavioural
The participants will carry out four experimental visits in a randomized order: CON_Calibré: control condition with a calibrated test meal; CON_AdLib: control condition with an ad libium test meal; EX_Calibré: exercise condition with a calibrated test meal; EX_AdLib: exercise condition with an ad libitm test meal. During each of the conditions, the participants will join the laboratory at 8:00 a.m. and will receive a calibrated breakfast. They will be asked at 11:00 a.m. either to rest in a semi-recumbent position for 30 minutes (CON conditions) or to perform a pedaling exercise on an ergocycle at 65% of their estimated aerobic capacity for 30 minutes. A test meal will be served to participants at 12:00 p.m., either ad libitum or calibrated. Appetite sensations will be assessed at regular intervals during each condition and their food reward preferences and ratio assessed 15 minutes before and 15 minutes after the test meals.
| Study group | Role | What they receive |
|---|---|---|
| rest with fixed meal | Experimental | Not described Receives: Behavioral: Exercice and meal |
| rest with ad libitum meal | Experimental | Not described Receives: Behavioral: Exercice and meal |
| Exercise with fixed meal | Experimental | Not described Receives: Behavioral: Exercice and meal |
| Exercise with ad libitum meal | Experimental | Not described Receives: Behavioral: Exercice and meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiety Quotient
Ratio between the energy content of the meal and the self-reported appetite feelings
Measured: During every experimental sessions, right after the lunch
Secondary outcomes (2)
Food reward
The liking and wanting for food items using a computerized questionnaire
Measured: During every experimental sessions,15 minutes before and 15 minutes after the lunch
Ad libitum food intake
energy ingested at a diner buffet meal
Measured: During every experimental sessions at diner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite ControlStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
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
- NCT05935072
- Sponsor's protocol ID
- RBHP 2023 BOIRIE
- Other IDs
- 2023-A00687-38
- Acronym
- EXHALIM
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Responses to Acute Exercise: Test of the Influence of the Nature of the Meal: EXHALIM Study
- ClinicalTrials.gov ID
- NCT05935072
- Acronym / sponsor ID
- EXHALIM / RBHP 2023 BOIRIE
- Conditions
- Appetite Control, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 7 Jul 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.
The management of body mass and energy balance requires a better understanding and mastery of the interactions between our daily activities, such as physical exercise, and the control of our food intake.
Over the past 15 years, many studies have focused on the potential effects of physical exercise on this satiety cascade and on subsequent food intake, in many populations. Thus, both in normal-weight subjects and in patients suffering from overweight and obesity, it has been shown that the performance of an acute exercise of moderate intensity promotes a transient anorectic effect, reducing feelings of hunger post -exercise, and can even induce a reduction in subsequent food intake. In healthy young adults, recent results show that high-intensity physical exercise can reduce feelings of hunger and increase the satietogenic effect of a meal compared to a control condition and low-intensity exercise. intensity. Nevertheless, it seems that the food reward (which refers to the notion of food reward) does not respond in the same way, the authors not observing any change in either liking or wanting, regardless of exercise intensity. Importantly, this literature uses ad libitum test meals, wishing to assess both satietogenic, hedonic and purely nutritional responses (assessing the amount of food intake). Nevertheless, these sensory and hedonic responses to food intake have recently been shown to be sensitive to the composition of the meal and its caloric quantity, which could induce a significant bias as to the conclusions on the effects of physical exercise. Indeed, the use of meals ad libitum, by definition, leads to caloric intake and different meal compositions. Thus, it is possible that the results obtained are strongly impacted by the nature of the test meal more than by the exercise itself. It therefore remains uncertain today to conclude as to the effects of physical exercise on the factors of the satietogenic cascade, since beyond physical exercise, the test meals compared are not identical. It therefore seems important today to develop a more coherent and adapted methodology, to better study the food and satietogenic responses to our daily activities.
In this context, the present project aims to compare the satietogenic response to a meal following acute exercise according to the nature of this meal (ad libitum versus calibrated) in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rest with fixed meal | Experimental | Behavioral: Exercice and meal |
| rest with ad libitum meal | Experimental | Behavioral: Exercice and meal |
| Exercise with fixed meal | Experimental | Behavioral: Exercice and meal |
| Exercise with ad libitum meal | Experimental | Behavioral: Exercice and meal |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male aged 18 to 30 (limits inclusive),
- with a body mass index between 20 and 25 kg.m².
- Able to give informed consent to participate in research
- Person subject to a Social Security scheme
Key exclusion criteria (16 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 being tested.
- Subjects undergoing energy restriction or weight loss program through physical activity at the time of inclusion or during the last 6 months.
- Taking medications that may interfere with study results
- Claustrophobia
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 |
|---|---|---|
| Exercice and mealThe participants will carry out four experimental visits in a randomized order: CON_Calibré: control condition with a calibrated test meal; CON_AdLib: control condition with an ad libium test meal; EX_Calibré: exercise condition with a calibrated test meal; EX_AdLib: exercise condition with an ad libitm test meal. During each of the conditions, the participants will join the laboratory at 8:00 a.m. and will receive a calibrated breakfast. They will be asked at 11:00 a.m. either to rest in a semi-recumbent position for 30 minutes (CON conditions) or to perform a pedaling exercise on an ergocycle at 65% of their estimated aerobic capacity for 30 minutes. A test meal will be served to participants at 12:00 p.m., either ad libitum or calibrated. Appetite sensations will be assessed at regular intervals during each condition and their food reward preferences and ratio assessed 15 minutes before and 15 minutes after the test meals. | Behavioural | Exercise with ad libitum meal, Exercise with fixed meal, rest with ad libitum meal, rest with fixed meal |
Primary outcome
Satiety Quotient
Time frame: During every experimental sessions, right after the lunch
Ratio between the energy content of the meal and the self-reported appetite feelings
2 secondary outcomes
Food reward
Time frame: During every experimental sessions,15 minutes before and 15 minutes after the lunch
Ad libitum food intake
Time frame: During every experimental sessions at diner
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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 Exercice and meal in people with Appetite Control 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satiety Quotient (time frame: During every experimental sessions, right after the lunch). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2023.