Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-01 @ 12:28 PM
Study NCT ID:
NCT06970457
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Interaction of Body Composition, Sex Hormones and Exercise in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat Mass', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Fat mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry'}, {'measure': 'Lean mass', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Lean mass, measured in kg and as a percentage of total body mass Measured through dual-energy X ray absorptiometry'}, {'measure': 'Testosterone', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Human testosterone, measured in serum via Novus Biologicals Human Testosterone ELISA Kit (Colorimetric). Measured in pg/mL.'}, {'measure': 'Human Growth Hormone', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Human Growth Hormone (HGH), measured in serum via R\\&D Systems™ Human Growth Hormone Quantikine ELISA Kit Measured in pg/mL'}, {'measure': 'Estradiol', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Human estradiol, measured in serum via Novus Biologicals Human Estradiol ELISA Kit (Colorimetric); measured in pg/mL'}, {'measure': 'SHBG', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Sex Hormone Binding Globulin (SHBG), measured in serum via R\\&D Systems™ Human SHBG Quantikine ELISA Kit; measured in pg/mL'}, {'measure': 'Luteinizing Hormone', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Luteinizing Hormone (LH), measured in serum via Invitrogen™ Luteinizing Hormone Human ELISA Kit; measured in pg/mL'}, {'measure': 'FSH', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Follicle Stimulating Hormone (FSH), measured in serum via Invitrogen™ Human FSH ELISA Kit; measured in pg/mL'}, {'measure': 'Adiponectin', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Adiponectin, measured in serum via Invitrogen™ Adiponectin Human ELISA Kit; measured in pg/mL'}, {'measure': 'Leptin', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Leptin, measured in serum via Invitrogen™ Leptin Human ELISA Kit; measured in pg/mL'}, {'measure': 'Aromatase', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Aromatase enzyme, measured in serum via Invitrogen™ Human Aromatase ELISA Kit; measured in ng/mL'}, {'measure': 'Insulin', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Insulin, measured in serum via Eagle Biosciences Inc Insulin Ultrasensitive ELISA; measured in mU/L'}, {'measure': 'KISS1', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Kisspeptin (KISS1), measured in serum via Biomatik Corporation Human Kisspeptin 1 (KISS1) ELISA Kit; measured in pg/mL'}, {'measure': 'GnRH', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Gonadotropin-releasing hormone (GnRH), measured in serum via Biomatik Corporation Human Gonadotropin Releasing Hormone (GnRH) ELISA Kit; measured in pg/mL'}, {'measure': 'Inflammatory Cytokine Panel', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Human High Sensitivity T-Cell 15-Plex Discovery Assay®, conducted by Eve Technologies, that includes GM-CSF, IFN-γ, IL-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p40, IL-12p70, IL-13, MCP-1 and TNFα; measured in pg/mL'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Triglycerides, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL'}, {'measure': 'Glucose', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Glucose, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL'}, {'measure': 'HDL-C', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'High-density Lipoprotein Cholesterol (HDL-C), measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Total Cholesterol, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in mg/dL'}, {'measure': 'Visceral Adipose Tissue', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Visceral Adipose Tissue (VAT), measured in g and g/cm3 via dual-energy X ray absorptiometry'}], 'secondaryOutcomes': [{'measure': 'ALT', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Alanine Transaminase (ALT) liver enzyme, measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in U/L'}, {'measure': 'AST', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Aspartate Aminotransferase (AST), measured in whole blood via Piccolo Xpress clinical chemistry analyzer with Lipid Panel Plus reagent discs; measured in U/L'}, {'measure': 'Bone Mineral Density', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Whole-body Bone Mineral Density (BMD), measured via dual-energy X ray absorptiometry; measured in g/cm3'}, {'measure': 'Height', 'timeFrame': 'Baseline/enrollment', 'description': 'Height, measured in inches via portable stadiometer'}, {'measure': 'Body Mass', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Body mass, measured in kg via Seca mBCA (medical body composition analyzer) 514'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Waist Circumference, measured in inches via standard Gulick tape measure.'}, {'measure': 'Free-living Dietary Intake', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Free-Living Dietary Intake, measured via 3-day food record. Participant completes the record for 3 days and returns to the researchers.'}, {'measure': 'Free-living Physical Activity', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Free-living Physical Activity, assessed through accelerometry via Actigraph wGT3X-BT accelerometers. Participant wears the accelerometer for 3 days, then returns it to the researchers.'}, {'measure': 'Aerobic Capacity', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Aerobic Capacity, also known as VO2peak, assessed via YMCA submaximal exercise test, completed on a cycle ergometer.'}, {'measure': 'Resting Energy Expenditure', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Resting Energy Expenditure (REE), measured via indirect calorimetry. The test is conducted with a Parvo Medics True One 2400 metabolic analysis system with a canopy hood; measured as kcal/day.'}, {'measure': 'Upper-body Muscle Strength', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Upper-body Muscle Strength, measured via three-repetition maximum (3RM) bench press; measured in pounds.'}, {'measure': 'Lower-body Muscle Strength', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Lower-body Muscle Strength, measured via knee extensor test with a Biodex dynamometer and three-repetition maximum (3RM) leg press exercise; measured as peak torque in Nm and pounds, respectively.'}, {'measure': 'Upper-body Muscle Power', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Upper-body Muscle Power, measured via seated medicine ball toss; measured in inches (thrown).'}, {'measure': 'Lower-body Muscle Power', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Lower-body Muscle Power, measured via maximal voluntary contraction of the knee extensors with a Biodex dynamometer; measured as peak torque in Nm.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline/enrollment only in control participants; Baseline/enrollment/pre-intervention and post-intervention (12 weeks after baseline testing) in intervention participants', 'description': 'Blood Pressure, both systolic and diastolic, measured with an automated blood pressure cuff; measured in mmHg.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['body composition', 'sex hormones', 'exercise', 'metabolic health'], 'conditions': ['Normal-weight Obesity']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to advance understanding of the causes of normal weight obesity (NWO) in men, namely the hormone profile and related potential mediating mechanisms, and the efficacy of different modes of exercise to restore body composition and cardiometabolic health in this population.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biological male\n* BMI 18.5 - 24.9 kg/m2 or \\>/= 30 kg/m2\n* Body fat \\<20% or \\>/= 25%\n* Ability and willingness to engage in an exercise training regimen\n\nExclusion Criteria:\n\n* Presence of a chronic health condition, or regular use of associate prescribed medications, that would substantially impact study variables\n* Excessive alcohol use or use of tobacco products, vape products, or illicit drugs\n* Presence of an electrical implant, such as a pacemaker'}, 'identificationModule': {'nctId': 'NCT06970457', 'acronym': 'AHA-NWO', 'briefTitle': 'The Interaction of Body Composition, Sex Hormones and Exercise in Men', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'The Interaction of Body Composition, Sex Hormones and Exercise in Men', 'orgStudyIdInfo': {'id': 'IRB-24-542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Exercise Training', 'description': '12-weeks of progressive and individualized resistance exercise training', 'interventionNames': ['Behavioral: Resistance Exercise Training', 'Behavioral: Aerobic Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic Exercise Training', 'description': '12-weeks of progressive and individualized aerobic exercise training', 'interventionNames': ['Behavioral: Resistance Exercise Training', 'Behavioral: Aerobic Exercise Training']}], 'interventions': [{'name': 'Resistance Exercise Training', 'type': 'BEHAVIORAL', 'description': '12-week progressive and individualized resistance exercise training program', 'armGroupLabels': ['Aerobic Exercise Training', 'Resistance Exercise Training']}, {'name': 'Aerobic Exercise Training', 'type': 'BEHAVIORAL', 'description': '12-week progressive and individualized aerobic exercise training program', 'armGroupLabels': ['Aerobic Exercise Training', 'Resistance Exercise Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sam Emerson, PhD', 'role': 'CONTACT', 'email': 'sam.emerson@okstate.edu', 'phone': '405-744-2303'}, {'name': 'Bree Baker, PhD', 'role': 'CONTACT', 'email': 'bree.baker@okstate.edu', 'phone': '405-744-9315'}, {'name': 'Sam Emerson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}], 'centralContacts': [{'name': 'Sam Emerson, PhD', 'role': 'CONTACT', 'email': 'sam.emerson@okstate.edu', 'phone': '4057442303'}, {'name': 'Bree Baker, PhD', 'role': 'CONTACT', 'email': 'bree.baker@okstate.edu', 'phone': '405-744-9315'}], 'overallOfficials': [{'name': 'Sam Emerson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}