Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake (TEMPCA)

December 8, 2022 updated by: Direction Centrale du Service de Santé des Armées

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

24

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 Locations

  • France
      • Brétigny-sur-Orge, France, 91223
        • Recruiting
        • Institut de Recherche Biomédicale des Armées
        • Contact:

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study population will be composed of young and healthy men.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Through study completion (30 months)

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

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 (Actual)

November 28, 2022

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021PBMD08
  • 2022-A01862-41 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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