Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT05178732
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Menstrual Cycle Phase and Protein Dose 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle protein synthesis', 'timeFrame': '7.5 hours', 'description': 'The rate of synthesis of new muscle protein'}], 'secondaryOutcomes': [{'measure': 'Plasma amino acid kinetics', 'timeFrame': '7.5 hours', 'description': 'The appearance of amino acids in the circulation.'}, {'measure': 'Serum insulin concentrations', 'timeFrame': '7.5 hours', 'description': 'Basal and postprandial concentrations of serum insulin'}, {'measure': 'Blood flow', 'timeFrame': '7.5 hours', 'description': 'Basal and postprandial blood flow using ultrasound'}, {'measure': 'Sex hormone concentrations', 'timeFrame': '5 minutes', 'description': 'Serum oestrogen and progesterone'}, {'measure': 'Gene expression', 'timeFrame': '7.5 hours', 'description': 'Gene expression of muscle samples using RNA extraction'}, {'measure': 'Blood glucose', 'timeFrame': '7.5 hours', 'description': 'Basal and postprandial concentrations of blood glucose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Protein Synthesis']}, 'descriptionModule': {'briefSummary': 'Adaptation to resistance exercise requires maximal rates of muscle protein synthesis, which can be achieved with post-exercise ingestion of \\~20g of protein. These recommendations are based on studies in males and responses in females may vary.\n\nMuscle recovery is related to the ability to build new muscle protein from amino acids (muscle protein synthesis). This response is thought to be impacted in females by hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis is not known.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18 and 30\n* Recreationally active\n* Regular menstrual cycle\n\nExclusion Criteria:\n\n* Smoking\n* Metabolic disease\n* Any motor disorder\n* Use of over-the-counter pharmaceuticals, during the study.\n* Pomegranate, milk or lidocaine allergy\n* Taken contraceptives in the past 3 months\n* Irregular menstrual cycle (less than 9 cycles per year and a length not between 21-35 days)\n* Post-menopausal women\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT05178732', 'briefTitle': 'The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis in Response to Exercise in Young Females', 'orgStudyIdInfo': {'id': '21-10-20-B-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein dose 1 and early', 'interventionNames': ['Dietary Supplement: Dose of protein', 'Other: Menstrual cycle phase']}, {'type': 'EXPERIMENTAL', 'label': 'Protein dose 1 and late', 'interventionNames': ['Dietary Supplement: Dose of protein', 'Other: Menstrual cycle phase']}, {'type': 'EXPERIMENTAL', 'label': 'Protein dose 2 and early', 'interventionNames': ['Dietary Supplement: Dose of protein', 'Other: Menstrual cycle phase']}, {'type': 'EXPERIMENTAL', 'label': 'Protein dose 2 and late', 'interventionNames': ['Dietary Supplement: Dose of protein', 'Other: Menstrual cycle phase']}, {'type': 'EXPERIMENTAL', 'label': 'Protein dose 3 and early', 'interventionNames': ['Dietary Supplement: Dose of protein', 'Other: Menstrual cycle phase']}, {'type': 'EXPERIMENTAL', 'label': 'Protein dose 3 and late', 'interventionNames': ['Dietary Supplement: Dose of protein', 'Other: Menstrual cycle phase']}], 'interventions': [{'name': 'Dose of protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One of three protein doses provided', 'armGroupLabels': ['Protein dose 1 and early', 'Protein dose 1 and late', 'Protein dose 2 and early', 'Protein dose 2 and late', 'Protein dose 3 and early', 'Protein dose 3 and late']}, {'name': 'Menstrual cycle phase', 'type': 'OTHER', 'description': 'Different phase of the menstrual cycle', 'armGroupLabels': ['Protein dose 1 and early', 'Protein dose 1 and late', 'Protein dose 2 and early', 'Protein dose 2 and late', 'Protein dose 3 and early', 'Protein dose 3 and late']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LT', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Francis Stephens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'collaborators': [{'name': 'P.volve', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}