NCT06809296

Brief 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 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.

Trial Health

65
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Feb 2025

Typical duration for all trials

Status
not yet recruiting

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

Study Progress58%
Feb 2025Apr 2027

First Submitted

Initial submission to the registry

January 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 22, 2025

Last Update Submit

January 30, 2025

Conditions

Keywords

Appetitefood intakeThermal exposureColdHeatEnergy intake

Outcome Measures

Primary Outcomes (3)

  • Energy intake

    Energy intake measured during the test ad libitum meal served at 01:00pm.

    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)

    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

    From date of the first experimental session until the last experimental session

Secondary Outcomes (5)

  • Rectal temperature

    From date of the first experimental session until the last experimental session

  • Skin temperature

    From date of the first experimental session until the last experimental session

  • Thermal sensation and comfort

    From date of the first experimental session until the last experimental session

  • Levels of interstitial glucose

    From date of the first experimental session until the last experimental session

  • Resting energy metabolism

    From date of the first experimental session until the last experimental session

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Active, young, lean, healthy individuals and presenting normal diet and sleep patterns.

You may qualify if:

  • Active (\>3 h/w of physical activites)
  • Affiliated to the social security
  • Usual breakfast eaters

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

  • Wasse 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.

  • Zakrzewski-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.

  • Charlot 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.

  • Millet 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.

  • Coca 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.

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Keyne Charlot, PhD

    Institut de Recherche Biomédical des Armées

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyne Charlot, PhD

CONTACT

Maxime Coca, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 5, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

All data and will be make available for other researchers on request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD will be available when an article will be published.
Access Criteria
Any researcher that will make a demand using e-mail address of the corresponfing author. They will have access to individual and mean data and the explanation of the gathered outcomes.