NCT05935072

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

July 12, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 29, 2023

Last Update Submit

July 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Satiety Quotient

    Ratio between the energy content of the meal and the self-reported appetite feelings

    During every experimental sessions, right after the lunch

Secondary Outcomes (2)

  • Food reward

    During every experimental sessions,15 minutes before and 15 minutes after the lunch

  • Ad libitum food intake

    During every experimental sessions at diner

Study Arms (4)

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

Interventions

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.

Exercise with ad libitum mealExercise with fixed mealrest with ad libitum mealrest with fixed meal

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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 being tested.
  • 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
  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Meals

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yves Boirie

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 7, 2023

Study Start

July 15, 2023

Primary Completion

April 15, 2024

Study Completion

March 15, 2025

Last Updated

July 12, 2023

Record last verified: 2023-06

Locations