Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-30 @ 4:20 PM
Study NCT ID:
NCT05347667
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on Muscle Protein Synthesis
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', 'interventionModelDescription': 'In a randomized fashion, participants will have one leg undergo unilateral resistance exercise training to assess the muscle protein synthetic response in each menstrual cycle phase OR each pill phase (active vs. placebo)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-31', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Rates of Muscle Protein Synthesis', 'timeFrame': '6 days', 'description': 'The investigators will use deuterated water and skeletal muscle biopsies to calculate the synthesis of skeletal muscle proteins.'}], 'secondaryOutcomes': [{'measure': 'Whole-body proteolysis', 'timeFrame': '6 days', 'description': 'The investigators will use 3-methylhistidine in urine to calculate the rate of whole-body myofibrillar protelysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstrual Cycle', 'Resistance Exercise', 'Muscle Protein Synthesis', 'OCP']}, 'referencesModule': {'references': [{'pmid': '39630025', 'type': 'RESULT', 'citation': 'Colenso-Semple LM, McKendry J, Lim C, Atherton PJ, Wilkinson DJ, Smith K, Phillips SM. Menstrual cycle phase does not influence muscle protein synthesis or whole-body myofibrillar proteolysis in response to resistance exercise. J Physiol. 2025 Mar;603(5):1109-1121. doi: 10.1113/JP287342. Epub 2024 Dec 4.'}]}, 'descriptionModule': {'briefSummary': "Skeletal muscle size and function is regulated by various factors, including hormones. While we understand the role of male sex hormones (testosterone), we aren't sure how female sex hormones (estrogen and progesterone) influence muscle mass and strength. Female physiology is unique in that hormones fluctuate throughout the menstrual cycle. In the first phase (follicular phase) following menstruation, estrogen levels are high while progesterone levels are low. In the second phase (luteal phase), progesterone levels are high. Females are often excluded from studies because researchers are concerned that the menstrual cycle might affect the results. The purpose of this study is to investigate the response to resistance exercise in each phase of the menstrual cycle."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy females, between the ages of 18 and 30 y with a regular menstrual cycle\n* Body Mass Index between 18.5 and 30.0 kg/m2\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* A history of neuromuscular disorders or muscle/bone wasting diseases\n* Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin-dependent or insulin-independent diabetes, or the presence of any other metabolic disease - all of which will be determined via a medical history screening questionnaire\n* The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.)\n* A (family) history of thrombosis\n* The use of anticoagulant medications\n* Consumption of tobacco-containing products\n* Excessive alcohol consumption (\\>21 units/wk)\n* History of bleeding diathesis, platelet or coagulation disorders\n* Currently pregnant\n* Irregular menstrual cycle as defined in the study protocol'}, 'identificationModule': {'nctId': 'NCT05347667', 'briefTitle': 'Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on Muscle Protein Synthesis', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Influence of Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on the Muscle Protein Synthetic Response to Exercise in Young, Healthy Women', 'orgStudyIdInfo': {'id': '14067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase', 'description': 'One leg will undergo 2 sessions of unilateral resistance exercise during the follicular phase of the menstrual cycle (pre-ovulation) OR during the active phase of taking the OCP', 'interventionNames': ['Other: Unilateral Resistance Exercise Leg', 'Other: Control Leg']}, {'type': 'EXPERIMENTAL', 'label': 'Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase', 'description': 'One leg will undergo 2 sessions of unilateral resistance exercise during the luteal phase of the menstrual cycle (post-ovulation) OR during the inactive phase of taking the OCP', 'interventionNames': ['Other: Unilateral Resistance Exercise Leg', 'Other: Control Leg']}], 'interventions': [{'name': 'Unilateral Resistance Exercise Leg', 'type': 'OTHER', 'description': 'One leg will perform unilateral resistance exercise', 'armGroupLabels': ['Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase', 'Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase']}, {'name': 'Control Leg', 'type': 'OTHER', 'description': 'One leg will serve as a non-exercise control', 'armGroupLabels': ['Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase', 'Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Exercise Metabolism Research Laboratory, McMaster Univeristy', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All participants will be assigned a unique subject ID, and therefore, other researchers involved with analyses will not have access to identifying participant information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natural Science and Engineering Research Council of Canada (NSERC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stuart Phillips', 'investigatorAffiliation': 'McMaster University'}}}}