- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935072
Nutritional Responses to Acute Exercise: Test of the Influence of the Nature of the Meal: (EXHALIM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LISE LACLAUTRE
- Phone Number: +33473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- CHU de Clermont-Ferrand
-
Contact:
- LISE LACLAUTRE
- Phone Number: +33473754963
- Email: promo_interne_drci@chu-clermontferrand.fr
-
Principal Investigator:
- Yves Boirie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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 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).
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: rest with fixed meal
|
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.
|
|
Experimental: rest with ad libitum meal
|
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.
|
|
Experimental: Exercise with fixed meal
|
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.
|
|
Experimental: Exercise with ad libitum meal
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
During every experimental sessions, right after the lunch
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food reward
Time Frame: During every experimental sessions,15 minutes before and 15 minutes after the lunch
|
The liking and wanting for food items using a computerized questionnaire
|
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
|
energy ingested at a diner buffet meal
|
During every experimental sessions at diner
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yves Boirie, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- RBHP 2023 BOIRIE
- 2023-A00687-38 (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.
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