Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05584527
Status:
UNKNOWN
Last Update Posted:
2022-12-09
First Post:
2022-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva and blood samples will be collected during each experimental visit :\n\n* saliva samples will be collected to measure salivary cortisol level.\n* blood samples will be collected to measure plasma levels of acylated ghrelin, leptin, peptide YY and Glucagon-like peptide-1.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total energy intake (in kilojoules) measured at the end of each condition (heat exposure, cold exposure and thermoneutral exposure)', 'timeFrame': 'Through study completion (30 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heat Exposure', 'Food Intake'], 'conditions': ['Eating Habit', 'Cold Exposure', 'Heat']}, 'descriptionModule': {'briefSummary': '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.\n\nAmong 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.\n\nUnderstanding how heat and cold exposure modifies appetite and energy intake therefore appears to be of great importance.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be composed of young and healthy men.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Aged 18 to 40 years old\n* Active (≥ 3 hours of physical activity per week)\n* Healthy (no metabolic pathology)\n* Affiliated to the social security system\n* Having given written consent to participate.\n\nExclusion Criteria:\n\n* Unusual eating pattern (\\< 3 meals per day) or irregular eating pattern\n* Pattern of dietary restriction (determined by the Three-Factor Eating Questionnaire-21)\n* 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)\n* Metabolic pathology\n* On medication\n* Previously exposed to unusual levels of heat or cold (vacation, missions) in the 4 months prior to inclusion\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT05584527', 'acronym': 'TEMPCA', 'briefTitle': 'Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake', 'orgStudyIdInfo': {'id': '2021PBMD08'}, 'secondaryIdInfos': [{'id': '2022-A01862-41', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Heat exposure (32°C)', 'type': 'OTHER', 'description': 'The participants will be exposed to heat (32°C) for 24 hours in a climatic apartment.\n\nDuring the exposure,\n\n* food intake and energy expenditure will be measured\n* several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc.\n* sleep brain activity will be monitored using a headband\n* urine and saliva samples will be collected.'}, {'name': 'Cold exposure (16°C)', 'type': 'OTHER', 'description': 'The participants will be exposed to cold (16°C) for 24 hours in a climatic apartment.\n\nDuring the exposure,\n\n* food intake and energy expenditure will be measured\n* several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc.\n* sleep brain activity will be monitored using a headband\n* urine and saliva samples will be collected.'}, {'name': 'Thermoneutral exposure (24°C)', 'type': 'OTHER', 'description': 'The participants will be exposed to a thermoneutral environment (24°C) for 24 hours in a climatic apartment.\n\nDuring the exposure,\n\n* food intake and energy expenditure will be measured\n* several physiological tests will be performed: hunger and thirst questionnaires, thermal sensations, skin temperature measurement, weighing, olfactory and gustatory capacities, food preference questionnaire, etc.\n* sleep brain activity will be monitored using a headband\n* urine and saliva samples will be collected.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91223', 'city': 'Brétigny-sur-Orge', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Keyne CHARLOT, PhD', 'role': 'CONTACT', 'email': 'keyne.charlot@intradef.gouv.fr', 'phone': '178651303', 'phoneExt': '+33'}], 'facility': 'Institut de Recherche Biomédicale des Armées', 'geoPoint': {'lat': 48.61135, 'lon': 2.30593}}], 'centralContacts': [{'name': 'Keyne CHARLOT, PhD', 'role': 'CONTACT', 'email': 'keyne.charlot@intradef.gouv.fr', 'phone': '178651303', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}