Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT05365334
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skeletal Muscle and Adipose Tissue Responses After Acute Exercise: Comparing Effects of Three Different Intensities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-translational modifications of skeletal muscle oxidative enzymes', 'timeFrame': '30 minutes before exercise', 'description': 'Western blot'}, {'measure': 'post-translational modifications of skeletal muscle oxidative enzymes', 'timeFrame': 'immediately after exercise', 'description': 'Western blot'}, {'measure': 'post-translational modifications of skeletal muscle oxidative enzymes', 'timeFrame': '60 minutes after exercise', 'description': 'Western blot'}, {'measure': 'post-translational modifications of Adipose tissue metabolic proteins', 'timeFrame': '15 minutes before exercise', 'description': 'Western blot'}, {'measure': 'post-translational modifications of Adipose tissue metabolic proteins', 'timeFrame': '75 minutes after exercise', 'description': 'Western blot'}, {'measure': 'mRNA expression of skeletal muscle oxidative enzymes', 'timeFrame': '30 minutes before exercise', 'description': 'qPCR'}, {'measure': 'mRNA expression of skeletal muscle oxidative enzymes', 'timeFrame': 'immediately after exercise', 'description': 'qPCR'}, {'measure': 'mRNA expression of skeletal muscle oxidative enzymes', 'timeFrame': '60 minutes after exercise', 'description': 'qPCR'}, {'measure': 'mRNA expression of adipose tissue metabolic enzymes', 'timeFrame': '15 minutes before exercise', 'description': 'qPCR'}, {'measure': 'mRNA expression of adipose tissue metabolic enzymes', 'timeFrame': '75 minutes after exercise', 'description': 'qPCR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cellular Responses Within Skeletal Muscle in Response to Exercise of Different Intensities', 'Relationship Between the Cellular Responses in Skeletal Muscle and the Changes in the Metabolomic Profile', 'Changes Within Adipose Tissue in Response to Exercise at the Three Different Intensities']}, 'descriptionModule': {'briefSummary': 'The study will assess the exercise-induced changes in chromatin accessibility and gene expression in a cell type-specific manner in skeletal muscle from healthy adults in response to exercise at three different intensities - 1) low-intensity continuous exercise, 2) moderate-intensity continuous exercise, and 3) high-intensity interval exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18-40\n* Body Mass Index: 20-30 kg/m2\n* Must engage in regularly planned aerobic-type exercise at moderate-vigorous intensity, 3 times per week for at least 30-60 minutes/session\n* Women must have regularly occurring menses and must be premenopausal\n* Subject willingness to opt-in for the Michigan Genomics Initiative (MGI) Repository\n\nExclusion Criteria:\n\n* Evidence/history of cardiovascular or metabolic disease.\n* Taking anti-coagulate medications or medications known to affect metabolism or inflammation\n* Weight instability ≥ ±3kg in the last 6 months\n* Tobacco or e-cigarette users\n* Women must not be pregnant or actively lactating'}, 'identificationModule': {'nctId': 'NCT05365334', 'acronym': '3X', 'briefTitle': 'Skeletal Muscle and Adipose Tissue Responses After Acute Exercise: Comparing Effects of Three Different Intensities', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Skeletal Muscle and Adipose Tissue Responses After Acute Exercise: Comparing Effects of Three Different Intensities', 'orgStudyIdInfo': {'id': 'HUM00204857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low-intensity continuous exercise', 'description': 'subjects will exercise at 30% maximal oxygen consumption (VO2max) for 45-60 minutes', 'interventionNames': ['Behavioral: Low intensity exercise session']}, {'type': 'EXPERIMENTAL', 'label': 'moderate-intensity continuous exercise', 'description': 'subjects will exercise at 65% maximal oxygen consumption (VO2max) for 30-45 minutes', 'interventionNames': ['Behavioral: Moderate intensity exercise session']}, {'type': 'EXPERIMENTAL', 'label': 'high-intensity interval exercise', 'description': 'subjects will completed 10x1minute exercise intervals at maximal oxygen consumption (VO2max) with 1 minute active recovery between', 'interventionNames': ['Behavioral: High intensity exercise session']}], 'interventions': [{'name': 'Low intensity exercise session', 'type': 'BEHAVIORAL', 'description': 'subjects will exercise at 30% maximal oxygen consumption (VO2max) for 45-60 minutes', 'armGroupLabels': ['low-intensity continuous exercise']}, {'name': 'Moderate intensity exercise session', 'type': 'BEHAVIORAL', 'description': 'subjects will exercise at 65% maximal oxygen consumption (VO2max) for 30-45 minutes', 'armGroupLabels': ['moderate-intensity continuous exercise']}, {'name': 'High intensity exercise session', 'type': 'BEHAVIORAL', 'description': 'subjects will completed 10x1minute exercise intervals at maximal oxygen consumption (VO2max) with 1 minute active recovery between', 'armGroupLabels': ['high-intensity interval exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Movement Science and Director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology', 'investigatorFullName': 'Jeffrey F Horowitz', 'investigatorAffiliation': 'University of Michigan'}}}}