Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-04-17 @ 3:56 AM
Study NCT ID:
NCT02157233
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-exercise Food Intake Regulation in a Hot Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C092779', 'term': 'RE1-silencing transcription factor'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative post-exercise and post-rest energy intake', 'timeFrame': '11 months'}], 'secondaryOutcomes': [{'measure': 'Appetite hormones', 'timeFrame': '13 months', 'description': 'insulin, CCK, leptin, ghrelin, pancreatic peptide'}, {'measure': 'Heart rate variability', 'timeFrame': '11 months'}, {'measure': 'Tympanic temperature', 'timeFrame': '11 months'}, {'measure': 'Peak exercise capacity', 'timeFrame': '11 months'}, {'measure': 'Appetite visual analogic scale', 'timeFrame': '11 months'}, {'measure': 'metabolic markers', 'timeFrame': '13 months', 'description': 'glucose, lipid profile, cortisol'}, {'measure': 'vascular biomarkers', 'timeFrame': '13 months', 'description': 'usCRP, inflammatory markers, hemorheological markers'}, {'measure': 'comfort visual scale', 'timeFrame': '11 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy and Physically Active Young Men']}, 'referencesModule': {'references': [{'pmid': '27621189', 'type': 'DERIVED', 'citation': 'Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men. Metabolism. 2016 Oct;65(10):1541-9. doi: 10.1016/j.metabol.2016.07.004. Epub 2016 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy and physically active men aged 18-30 years\n\nExclusion Criteria:\n\n* any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,\n* ear troubles"}, 'identificationModule': {'nctId': 'NCT02157233', 'acronym': 'APPA', 'briefTitle': 'Post-exercise Food Intake Regulation in a Hot Environment', 'organization': {'class': 'OTHER', 'fullName': 'University of the French West Indies and French Guiana'}, 'officialTitle': 'Post-exercise Food Intake Regulation in a Hot Environment', 'orgStudyIdInfo': {'id': '13/N/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hot environment', 'description': 'Subjects will perform the intervention in a hot environment (33°C)', 'interventionNames': ['Behavioral: Rest', 'Behavioral: Exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'Neutral environment', 'description': 'Subjects will perform the intervention in a neutral environment (22°C)', 'interventionNames': ['Behavioral: Rest', 'Behavioral: Exercise']}], 'interventions': [{'name': 'Rest', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Hot environment', 'Neutral environment']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Hot environment', 'Neutral environment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Les Abymes', 'state': 'Guadeloupe', 'country': 'France', 'facility': 'CREPS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the French West Indies and French Guiana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}