AppetiteTEMPCA2NCT06809296
Assessment of the Effects of Acute Exposure to Cold and Heat on Appetite
An observational study of Appetite, run by Direction Centrale du Service de Santé des Armées.
Trial summary
Military personnel and athletes have a very high energy expenditure, which is increased during certain key periods (intense training, competition and missions). Compensating for this expenditure through adequate energy intake can be complicated by physiological ingestive limits and logistical and organizational… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Active, young, lean, healthy individuals and presenting normal diet and sleep patterns.
Who may be able to join
- Active (>3 h/w of physical activites)
- Affiliated to the social security
- Usual breakfast eaters
Who cannot join
- Unusual or irregular meal pattern
- Too high dietary restrictive profile assessed by the TFEQ-21
- Bad sleepers (< 6h/night)
- Presenting a metabolic condition
- BMI lower than 18 or higher than 30
- Chronic medication (at the exception of the contraceptive pills)
Show all 11Show fewer
- Regular smoker (more than 2 cigarettes per day)
- Regular alcohol consumer (more then 1 glass per day)
- Vegetarian
- Following a confessional diet (hallal, casher)
- Do not speak fluently French
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Effects of Acute Exposure to Cold and Heat on Appetite: Impact of Serving Food Temperature (Hot and Cold Meals)
Military personnel and athletes have a very high energy expenditure, which is increased during certain key periods (intense training, competition and missions). Compensating for this expenditure through adequate energy intake can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, food availability), leading these populations to regularly find themselves in an energy deficit situation (intake below requirements). If this situation persists, it could impair physical and cognitive performance, as well as major physiological functions. Among the many constraints to which military personnel and athletes are subjected (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficiency, the impact of thermal environmental constraints is very imperfectly known. Seasonal impact and travel to countries with very different thermal environments from temperate countries can lead these populations to work in cold and hot conditions for long periods.
Understanding how exposure to hot and cold alters appetite and energy intake is therefore of the high importance. Our previous "TEMPCA" study highlighted a modulation of preferences for warm or cold foods depending on the exposure environment. By being able to adapt their food intake to these preferences, subjects were able to maintain a decent energy intake.
Read more
The primary objective of this study is to determine the effect of the temperature of the food served (hot or cold) on changes in food intake during acute exposure to hot and cold. We hypothesized that adapting the temperature of the food served according to the exposure environment (hot in a cold environment and cold in a hot environment) would enable adequate levels of energy intake.
Secondary objectives are to determine the influence of the environment on the levels of interstitial glucose during the preprandial period and to investigate the impact of thermal exposure (modulation of core temperature) on the modulation of quantities consumed and energy produced by digestion (postprandial thermogenesis). Forty participants (between 18 and 40 yo, male or female, active, lean, and healthy) will carry out 3 experimental sessions in which only the thermal environment will differ: cold condition (15°C), neutral condition (25°C) and warm condition (35°C). They will be divided into two groups, the first of which will be offered a cold meal during the three sessions (Cold Meal - CM) and the second a warm meal during the three sessions (Warm Meal - WM). They will all wear the same outfit designed to be offer perfect thermal comfort at 25 °C.
Briefly, each session will start at 8:30am after eating a standardized breakfast. Body mass and ad libitum water intake will be frequently monitored to identify possible dehydration. Thermal comfort and sensation and subjective appetite will be regularly assessed using visual analog scale.
From 11:00am to 01:00pm, all participants will be isolated and all temporal cues will be removed. At 01:00pm, an ad libitum meal (warm or cold) will be served in large quantities. The dishes will be weighed before and after the meal to assess energy intake. Before and after the meal, resting metabolism will be measured during 30 min in a supine position using indirect calorimetry and food preferences for high-fat/low-fat, savory/sweet, warm/cold foods, and fluid/solid foods will be assessed using the Leeds Food Preference Questionnaire.
- Conditions
- Appetite
- Keywords
- Appetite, food intake, Thermal exposure, Cold, Heat, Energy intake
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Warm Meal (WM) | This group will receive an ad libitum warm meal at 01:00pm after 4h30 of exposure to threee different thermal environments | |
| Cold Meal | This group will receive an ad libitum cold meal at 01:00pm after 4h30 of exposure to threee different thermal environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Energy intake measured during the test ad libitum meal served at 01:00pm.
Measured: From date of the first experimental session until the last experimental session
Subjective appetite
Hunger, desire to eat, prospective consumption, gastric fullness, and thirst feelings will be assessed using 10-cm visual analog scales each hour from the begininng (8:30 am) to the end of the exposure (03:00pm)
Measured: From date of the first experimental session until the last experimental session
Food preferences
Food preferences for high-fat/low-fat, sweet/savory foods and for warm/cold and fluid/solid foods will be assessed using the Leeds Food Preference Questionnaire at 12:30am and 01:30pm
Measured: From date of the first experimental session until the last experimental session
Secondary outcomes (5)
Rectal temperature
Using a rectal probe continuously during the three thermal exposures
Measured: From date of the first experimental session until the last experimental session
Skin temperature
Using 4 thermobuttons on 4 different sites (chest, arm, thigh and back) continuously during the three thermal exposures
Measured: From date of the first experimental session until the last experimental session
Thermal sensation and comfort
Using visual analog scales each hour from the begininng (8:30 am) to the end of the exposure (03:00pm)
Measured: From date of the first experimental session until the last experimental session
Levels of interstitial glucose
Using a Freestyle Libre 2 (continuous glucose monitoring system) with a 5-min sample rate continuously during the three thermal exposures
Measured: From date of the first experimental session until the last experimental session
Resting energy metabolism
Using the Q-NRJ (Cosmed) during a 30-min measurement in a supine position 60 minutes before the meal (12:00 am) and 60 minutes after the meal (02:00 pm)
Measured: From date of the first experimental session until the last experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AppetiteStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
- Responsible party
- Sponsor
- Investigators
- Keyne Charlot, PhD, Principal investigator, Institut de Recherche Biomédical des Armées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809296
- Sponsor's protocol ID
- 2024PPRC09
- Other IDs
- 2024-A02285-42
- Acronym
- TEMPCA2
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data and will be make available for other researchers on request.
Publications
Tassone EC, Baker BA. Body weight and body composition changes during military training and deployment involving the use of combat rations: a systematic literature review. Br J Nutr. 2017 Mar;117(6):897-910. doi: 10.1017/S0007114517000630.
PubMed 28452292Wasse LK, King JA, Stensel DJ, Sunderland C. Effect of ambient temperature during acute aerobic exercise on short-term appetite, energy intake, and plasma acylated ghrelin in recreationally active males. Appl Physiol Nutr Metab. 2013 Aug;38(8):905-9. doi: 10.1139/apnm-2013-0008. Epub 2013 May 1.
PubMed 23855280Zakrzewski-Fruer JK, Horsfall RN, Cottrill D, Hough J. Acute exposure to a hot ambient temperature reduces energy intake but does not affect gut hormones in men during rest. Br J Nutr. 2021 Apr 28;125(8):951-959. doi: 10.1017/S0007114520002792. Epub 2020 Jul 22.
PubMed 32693846Charlot K. Negative energy balance during military training: The role of contextual limitations. Appetite. 2021 Sep 1;164:105263. doi: 10.1016/j.appet.2021.105263. Epub 2021 Apr 20.
PubMed 33862189Millet J, Siracusa J, Tardo-Dino PE, Thivel D, Koulmann N, Malgoyre A, Charlot K. Effects of Acute Heat and Cold Exposures at Rest or during Exercise on Subsequent Energy Intake: A Systematic Review and Meta-Analysis. Nutrients. 2021 Sep 28;13(10):3424. doi: 10.3390/nu13103424.
PubMed 34684424Coca M, Besancon L, Erblang M, Bourdon S, Gruel A, Lepetit B, Beauchamps V, Tavard B, Oustric P, Finlayson GS, Thivel D, Malgoyre A, Tardo-Dino PE, Bourrilhon C, Charlot K. Twenty four-hour passive heat and cold exposures did not modify energy intake and appetite but strongly modify food reward. Br J Nutr. 2024 Jul 28;132(2):209-226. doi: 10.1017/S0007114524000825. Epub 2024 Apr 18.
PubMed 38634266
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Acute Exposure to Cold and Heat on Appetite: Impact of Serving Food Temperature (Hot and Cold Meals)
- ClinicalTrials.gov ID
- NCT06809296
- Acronym / sponsor ID
- TEMPCA2 / 2024PPRC09
- Conditions
- Appetite
- Keywords
- Appetite, food intake, Thermal exposure, Cold, Heat, Energy intake
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Feb 2025 (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 missions). Compensating for this expenditure through adequate energy intake can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, food availability), leading these populations to regularly find themselves in an energy deficit situation (intake below requirements). If this situation persists, it could impair physical and cognitive performance, as well as major physiological functions. Among the many constraints to which military personnel and athletes are subjected (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficiency, the impact of thermal environmental constraints is very imperfectly known. Seasonal impact and travel to countries with very different thermal environments from temperate countries can lead these populations to work in cold and hot conditions for long periods.
Understanding how exposure to hot and cold alters appetite and energy intake is therefore of the high importance. Our previous "TEMPCA" study highlighted a modulation of preferences for warm or cold foods depending on the exposure environment. By being able to adapt their food intake to these preferences, subjects were able to maintain a decent energy intake.
The primary objective of this study is to determine the effect of the temperature of the food served (hot or cold) on changes in food intake during acute exposure to hot and cold. We hypothesized that adapting the temperature of the food served according to the exposure environment (hot in a cold environment and cold in a hot environment) would enable adequate levels of energy intake.
Secondary objectives are to determine the influence of the environment on the levels of interstitial glucose during the preprandial period and to investigate the impact of thermal exposure (modulation of core temperature) on the modulation of quantities consumed and energy produced by digestion (postprandial thermogenesis). Forty participants (between 18 and 40 yo, male or female, active, lean, and healthy) will carry out 3 experimental sessions in which only the thermal environment will differ: cold condition (15°C), neutral condition (25°C) and warm condition (35°C). They will be divided into two groups, the first of which will be offered a cold meal during the three sessions (Cold Meal - CM) and the second a warm meal during the three sessions (Warm Meal - WM). They will all wear the same outfit designed to be offer perfect thermal comfort at 25 °C.
Briefly, each session will start at 8:30am after eating a standardized breakfast. Body mass and ad libitum water intake will be frequently monitored to identify possible dehydration. Thermal comfort and sensation and subjective appetite will be regularly assessed using visual analog scale.
From 11:00am to 01:00pm, all participants will be isolated and all temporal cues will be removed. At 01:00pm, an ad libitum meal (warm or cold) will be served in large quantities. The dishes will be weighed before and after the meal to assess energy intake. Before and after the meal, resting metabolism will be measured during 30 min in a supine position using indirect calorimetry and food preferences for high-fat/low-fat, savory/sweet, warm/cold foods, and fluid/solid foods will be assessed using the Leeds Food Preference Questionnaire.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm Meal (WM) | – | –This group will receive an ad libitum warm meal at 01:00pm after 4h30 of exposure to threee different thermal environments |
| Cold Meal | – | –This group will receive an ad libitum cold meal at 01:00pm after 4h30 of exposure to threee different thermal environments |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Active, young, lean, healthy individuals and presenting normal diet and sleep patterns.
Key inclusion criteria (3 listed)
- Active (>3 h/w of physical activites)
- Affiliated to the social security
- Usual breakfast eaters
Key exclusion criteria (11 listed)
- Unusual or irregular meal pattern
- Too high dietary restrictive profile assessed by the TFEQ-21
- Bad sleepers (< 6h/night)
- Presenting a metabolic condition
- BMI lower than 18 or higher than 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy intake
Time frame: From date of the first experimental session until the last experimental session
Energy intake measured during the test ad libitum meal served at 01:00pm.
Subjective appetite
Time frame: From date of the first experimental session until the last experimental session
Hunger, desire to eat, prospective consumption, gastric fullness, and thirst feelings will be assessed using 10-cm visual analog scales each hour from the begininng (8:30 am) to the end of the exposure (03:00pm)
Food preferences
Time frame: From date of the first experimental session until the last experimental session
Food preferences for high-fat/low-fat, sweet/savory foods and for warm/cold and fluid/solid foods will be assessed using the Leeds Food Preference Questionnaire at 12:30am and 01:30pm
5 secondary outcomes
Rectal temperature
Time frame: From date of the first experimental session until the last experimental session
Skin temperature
Time frame: From date of the first experimental session until the last experimental session
Thermal sensation and comfort
Time frame: From date of the first experimental session until the last experimental session
Levels of interstitial glucose
Time frame: From date of the first experimental session until the last experimental session
Resting energy metabolism
Time frame: From date of the first experimental session until the last experimental session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Results publication: PubMed 28452292Tassone EC, Baker BA. Body weight and body composition changes during military training and deployment involving the use of combat rations: a systematic literature review. Br J Nutr. 2017 Mar;117(6):897-910. doi: 10.1017/S0007114517000630.
- Results publication: PubMed 23855280Wasse LK, King JA, Stensel DJ, Sunderland C. Effect of ambient temperature during acute aerobic exercise on short-term appetite, energy intake, and plasma acylated ghrelin in recreationally active males. Appl Physiol Nutr Metab. 2013 Aug;38(8):905-9. doi: 10.1139/apnm-2013-0008. Epub 2013 May 1.
- Results publication: PubMed 32693846Zakrzewski-Fruer JK, Horsfall RN, Cottrill D, Hough J. Acute exposure to a hot ambient temperature reduces energy intake but does not affect gut hormones in men during rest. Br J Nutr. 2021 Apr 28;125(8):951-959. doi: 10.1017/S0007114520002792. Epub 2020 Jul 22.
- Results publication: PubMed 33862189Charlot K. Negative energy balance during military training: The role of contextual limitations. Appetite. 2021 Sep 1;164:105263. doi: 10.1016/j.appet.2021.105263. Epub 2021 Apr 20.
- Results publication: PubMed 34684424Millet J, Siracusa J, Tardo-Dino PE, Thivel D, Koulmann N, Malgoyre A, Charlot K. Effects of Acute Heat and Cold Exposures at Rest or during Exercise on Subsequent Energy Intake: A Systematic Review and Meta-Analysis. Nutrients. 2021 Sep 28;13(10):3424. doi: 10.3390/nu13103424.
- Results publication: PubMed 38634266Coca M, Besancon L, Erblang M, Bourdon S, Gruel A, Lepetit B, Beauchamps V, Tavard B, Oustric P, Finlayson GS, Thivel D, Malgoyre A, Tardo-Dino PE, Bourrilhon C, Charlot K. Twenty four-hour passive heat and cold exposures did not modify energy intake and appetite but strongly modify food reward. Br J Nutr. 2024 Jul 28;132(2):209-226. doi: 10.1017/S0007114524000825. Epub 2024 Apr 18.
- Individual participant dataSharing planned: Yes. All data and will be make available for other researchers on request.
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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.
Keyne Charlot, PhD principal investigator
Institut de Recherche Biomédical des Armées
Questions about this trial
What is this clinical trial studying?
An observational study of Appetite, run by Direction Centrale du Service de Santé des Armées.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyne Charlot, PhD (+33637968040, keynecharlot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: From date of the first experimental session until the last experimental session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06809296, which also lists 6 linked publications.
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 5 Feb 2025.