Assessment of the Effects of Acute Exposure to Cold and Heat on Appetite (TEMPCA2)

January 30, 2025 updated by: Direction Centrale du Service de Santé des Armées

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.

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of the first experimental session until the last experimental session
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)
From date of the first experimental session until the last experimental session
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
From date of the first experimental session until the last experimental session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Using 4 thermobuttons on 4 different sites (chest, arm, thigh and back) continuously during the three thermal exposures
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
Using 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
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
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
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)
From date of the first experimental session until the last experimental session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Collaborators

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

Investigators

  • Principal Investigator: Keyne Charlot, PhD, Institut de Recherche Biomédical des Armées

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024PPRC09
  • 2024-A02285-42 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

IPD will be available when an article will be published.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Appetite

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe