Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT06961734
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2025-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatmax Exercise in Menstrual Phases: Effects on Fat Metabolism & Body Composition in NWO Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-20', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid profile', 'timeFrame': '8 weeks', 'description': 'The changes of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, and triglyceride before and after intervention.'}, {'measure': 'Body Fat Mass', 'timeFrame': '8 weeks', 'description': 'Body fat mass (kg) will be assessed using dual-energy X-ray absorptiometry (DXA) scans. The change of body fat mass before and after intervention.'}, {'measure': 'Percentage of Body Fat', 'timeFrame': '8 weeks', 'description': 'The change of percentage of body fat before and after intervention.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '8 weeks', 'description': 'Changes in Body mass index before and after Intervention. Body mass index is calculated from the formula, Weight (kg) / Height2 (m2), its unit is kg/m2.'}, {'measure': 'Waist Circumference', 'timeFrame': '8 weeks', 'description': 'The change of waist circumference before and after intervention.'}, {'measure': 'Hip Circumference', 'timeFrame': '8 weeks', 'description': 'The change of hip circumference before and after intervention.'}, {'measure': 'Apolipoprotein A-I (g/L)', 'timeFrame': '8 weeks', 'description': 'The change in apolipoprotein A-I levels before and after the intervention.'}, {'measure': 'Apolipoprotein B (g/L)', 'timeFrame': '8 weeks', 'description': 'The change in apolipoprotein B levels before and after the intervention.'}, {'measure': 'Maximal Oxygen uptake (VO2max)', 'timeFrame': '8 weeks', 'description': 'Changes in Maximal Oxygen uptake before and after Intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aerobic exercise', 'menstrual cycle phase', 'normal weight obesity', 'lipid metabolism'], 'conditions': ['Fat Metabolism']}, 'descriptionModule': {'briefSummary': 'Effects of a Fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in NWO women', 'detailedDescription': 'This is a randomized clinical trial of single-blind with 3 arms (control group , follicular group and luteal group), in which a pre-treatment-posttest design has been used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Criteria: Inclusion Criteria:\n* Female, aged between 18 and 30 years old;\n* BMI between 18.5 and 24.9 kg/m2 with a BF% \\> 30% (normal weight obesity determination criteria);\n* Regular menstrual cycles for at least 3 months;\n* No use of oral contraceptives for at least 6 months before the experiment;\n* Non-smoker and non-alcohol abuser.\n\nExclusion Criteria:\n\n* The presence of CVD;\n* A diagnosis of cancer, pulmonary diseases, or other conditions that prevent participation in exercise;\n* The use of medications affecting body composition or metabolism.'}, 'identificationModule': {'nctId': 'NCT06961734', 'briefTitle': 'Fatmax Exercise in Menstrual Phases: Effects on Fat Metabolism & Body Composition in NWO Women', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Sport University'}, 'officialTitle': 'Effects of a Fatmax Exercise Intervention During Different Menstrual Cycle Phases on Fat Metabolism and Body Composition in Normal Weight Obese Women', 'orgStudyIdInfo': {'id': 'EFEIDDMCPFMBCNWOW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'follicular group', 'interventionNames': ['Behavioral: follicular group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'luteal group', 'interventionNames': ['Behavioral: luteal group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'follicular group', 'type': 'BEHAVIORAL', 'description': 'Exercised at Fatmax intensity four times per week and plus three additional exercise during the late follicular phase of each cycle.', 'armGroupLabels': ['follicular group']}, {'name': 'luteal group', 'type': 'BEHAVIORAL', 'description': 'Exercised at Fatmax intensity four times per week and plus three additional exercise during the mid- luteal phase of each cycle.', 'armGroupLabels': ['luteal group']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'Exercised at Fatmax intensity four times per week.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'School of Sports Medicine and Rehabilitation, Beijing Sport University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Sport University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}