Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT01036360
Status:
UNKNOWN
Last Update Posted:
2011-01-19
First Post:
2009-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Exercise and Energy Balance Regulation: Effect of Intensity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'Defined population'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2009-12-18', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of energy intake over the 24 hours is the primary outcome. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise', 'timeFrame': 'over the 24 hours'}], 'secondaryOutcomes': [{'measure': 'Appetite feeling and substrate utilization are the two second outcomes. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise', 'timeFrame': 'with an interval of at least 7 days'}]}, 'conditionsModule': {'keywords': ['Obesity', 'Acute exercise', 'Intensity of exercise', 'Energy balance regulation', 'Appetite'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23724881', 'type': 'DERIVED', 'citation': 'Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duche P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.'}, {'pmid': '22272251', 'type': 'DERIVED', 'citation': 'Thivel D, Isacco L, Montaurier C, Boirie Y, Duche P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.'}, {'pmid': '21376093', 'type': 'DERIVED', 'citation': 'Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duche P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.', 'detailedDescription': '20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each. A first session will be considered as sedentary, and volunteers will remain inactive. During the second and third session, they will have to complete a cycling test generating an energy expenditure of 400 Kcal, once at low intensity (40%VO2max) and once at high intensity (70% VO2max). Those three sessions will be realized in a randomized order with an interval of at least 7 days and urinary collection over the 24hours will be done during all the sessions. At the beginning of the protocol, blood samples will be taken, body composition assessed by DXA and adiposity location evaluated by MNR.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Adults between 18 to 30 years old and adolescents between 12 and 15 years old\n* Body mass index :\n\n * lean adults : 20 \\<BMI\\< 25 kg.m²\n * obese adults : 30\\<BMI\\<38 kg.m²\n * lean adolescents: BMI \\<90th percentile\n * obese adolescents: BMI\\>97th percentile\n* Affiliated to National Health Insurance\n* Subject giving his written informed consent\n* Subject considered as normal after clinical examination and medical questionnaire.\n\nExclusion Criteria:\n\n* Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments\n* Refusal to be registered on the National Volunteers Data file\n* Being in exclusion on the National Volunteers Data file\n* Practising intensive physical exercise\n* Heavy consumer of alcohol or/and tobacco\n* Previous medical and/or surgery judged by the investigator as incompatible with this study'}, 'identificationModule': {'nctId': 'NCT01036360', 'briefTitle': 'Acute Exercise and Energy Balance Regulation: Effect of Intensity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status', 'orgStudyIdInfo': {'id': 'CHU-0063'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'physical activity', 'interventionNames': ['Other: metabolic chamber']}], 'interventions': [{'name': 'metabolic chamber', 'type': 'OTHER', 'description': '20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each', 'armGroupLabels': ['physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Corinne BOUTELOUP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Clermont-Ferrand (CRNH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regional Program for Clinical Research 2009 (PHRC 2009)', 'class': 'UNKNOWN'}, {'name': 'Thermal Institution of Brides les Bains (FRANCE)', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Patrick LACARIN', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}