Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake

Eating Habit Clinical Trial

— TEMPCA  

Official title:

Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584527
• Other study ID #: 2021PBMD08
• Secondary ID: 2022-A01862-41
• Status: Recruiting
• Start date: November 28, 2022
• Est. completion date: May 2025

Study information

• Verified date: December 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Keyne CHARLOT, PhD
• Phone: 178651303
• Email: keyne.charlot[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Military personnel and athletes have a very high energy expenditure which is increased during certain key periods (intense training, competition and mission). Compensating for this expenditure through food can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, availability of food), which leads these populations to regularly experience energy deficit situations (intake below requirements), which could alter physical and cognitive performance and major physiological functions. Among the many constraints to which military personnel and athletes are exposed to (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficits, the impact of thermal environmental constraints is not well known. The seasonal impact and travel to countries with very different thermal environments can lead these populations to experience cold and hot conditions for long periods. Understanding how heat and cold exposure modifies appetite and energy intake therefore appears to be of great importance. The hypothesis of this study is that a 24 h heat exposure would produce a rapid and long-lasting anorexigenic action impacting energy intake, while a cold exposure would produce the opposite effect (orexigenic action).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male
• Aged 18 to 40 years old
• Active (= 3 hours of physical activity per week)
• Healthy (no metabolic pathology)
• Affiliated to the social security system
• Having given written consent to participate.

Exclusion Criteria:

• Unusual eating pattern (< 3 meals per day) or irregular eating pattern
• Pattern of dietary restriction (determined by the Three-Factor Eating Questionnaire-21)
• Unusual sleep pattern (Epworth score > 10, insomnia severity score > 14, Pittsburgh Sleep Quality Index > 5), sleep duration < 6 h per night or difficulty falling asleep)
• Metabolic pathology
• On medication
• Previously exposed to unusual levels of heat or cold (vacation, missions) in the 4 months prior to inclusion
• Refusal to participate.

Related Conditions & MeSH terms

• Cold Exposure
• Eating Habit
• Heat

Intervention

Other:
• Heat exposure (32°C)
The participants will be exposed to heat (32°C) for 24 hours in a climatic apartment. During the exposure, food intake and energy expenditure will be measured several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc. sleep brain activity will be monitored using a headband urine and saliva samples will be collected.
• Cold exposure (16°C)
The participants will be exposed to cold (16°C) for 24 hours in a climatic apartment. During the exposure, food intake and energy expenditure will be measured several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc. sleep brain activity will be monitored using a headband urine and saliva samples will be collected.
• Thermoneutral exposure (24°C)
The participants will be exposed to a thermoneutral environment (24°C) for 24 hours in a climatic apartment. During the exposure, food intake and energy expenditure will be measured several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc. sleep brain activity will be monitored using a headband urine and saliva samples will be collected.

Locations

Country	Name	City	State
France	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total energy intake (in kilojoules) measured at the end of each condition (heat exposure, cold exposure and thermoneutral exposure)		Through study completion (30 months)