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NCT Number: NCT06809296

Assessment of the Effects of Acute Exposure to Cold and Heat on Appetite

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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)

  3. 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

Secondary outcomes

  1. Rectal temperature

    Time frame: From date of the first experimental session until the last experimental session

    Using a rectal probe continuously during the three thermal exposures

  2. Skin temperature

    Time frame: From date of the first experimental session until the last experimental session

    Using 4 thermobuttons on 4 different sites (chest, arm, thigh and back) continuously during the three thermal exposures

  3. Thermal sensation and comfort

    Time frame: From date of the first experimental session until the last experimental session

    Using visual analog scales each hour from the begininng (8:30 am) to the end of the exposure (03:00pm)

  4. Levels of interstitial glucose

    Time frame: From date of the first experimental session until the last experimental session

    Using a Freestyle Libre 2 (continuous glucose monitoring system) with a 5-min sample rate continuously during the three thermal exposures

  5. Resting energy metabolism

    Time frame: From date of the first experimental session until the last experimental session

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Keyne Charlot, PhD

CONTACT

[email protected]

+33637968040

Maxime Coca, Master

CONTACT

[email protected]

+33632563113

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Collaborators

  • Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France

Registry information

Official study title

Evaluating the Effects of Acute Exposure to Cold and Heat on Appetite: Impact of Serving Food Temperature (Hot and Cold Meals)

Acronym: TEMPCA2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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