Eating HabitTEMPCANCT05584527
Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake
An observational study of Eating Habit and Cold Exposure, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Habit, Cold Exposure, Heat
- What is being tested?
- Heat exposure (32°C), Cold exposure (16°C) and Thermoneutral exposure (24°C)
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2022to May 2025
- Phase
- Observational
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study population will be composed of young and healthy men.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Keyne CHARLOT, PhD, 178651303 ext. +33, keyne.charlot@intradef.gouv.fr
About this study
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.
Read more
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).
- Conditions
- Eating Habit, Cold Exposure, Heat
- Being tested
- Heat exposure (32°C), Cold exposure (16°C), Thermoneutral exposure (24°C)
- Keywords
- Heat Exposure, Food Intake
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat exposure (32°C)Other
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)Other
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)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy intake (in kilojoules) measured at the end of each condition (heat exposure, cold exposure and thermoneutral exposure)
Measured: Through study completion (30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start28 Nov 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating HabitStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584527
- Sponsor's protocol ID
- 2021PBMD08
- Other IDs
- 2022-A01862-41
- Acronym
- TEMPCA
- Status last verified
- Dec 2022
- First submitted
- 14 Oct 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake
- ClinicalTrials.gov ID
- NCT05584527
- Acronym / sponsor ID
- TEMPCA / 2021PBMD08
- Conditions
- Eating Habit, Cold Exposure, Heat
- Keywords
- Heat Exposure, Food Intake
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 18 Oct 2022 (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.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be composed of young and healthy men.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| 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. | Other | – |
| 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. | Other | – |
| 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. | Other | – |
Primary outcome
Total energy intake (in kilojoules) measured at the end of each condition (heat exposure, cold exposure and thermoneutral exposure)
Time frame: Through study completion (30 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Habit and Cold Exposure, run by Direction Centrale du Service de Santé des Armées 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 6 inclusion and 7 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 9 Dec 2022. 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 Keyne CHARLOT, PhD (178651303 ext. +33, keyne.charlot@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy intake (in kilojoules) measured at the end of each condition (heat exposure, cold exposure and thermoneutral exposure) (time frame: Through study completion (30 months)). 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 9 Dec 2022.