Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-29 @ 6:59 AM
Study NCT ID:
NCT03934632
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019518', 'term': 'Postprandial Period'}, {'id': 'D007103', 'term': 'Immobilization'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-29', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle protein breakdown rate', 'timeFrame': '1 hour', 'description': 'Muscle protein breakdown rate (FBR, measured in %/h) during 1 hour of saline or amino acid infusion'}], 'secondaryOutcomes': [{'measure': 'Muscle protein breakdown rate', 'timeFrame': '3 hours', 'description': 'Muscle protein breakdown rate (FBR, measured in %/h) during 3 hours of saline or amino acid infusion'}, {'measure': 'Muscle protein synthesis rate', 'timeFrame': '3 hours', 'description': 'Muscle protein synthesis rate (FSR, measured in %/h) during 3 hours of saline or amino acid infusion measured using a D5 phenylalanine infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* 18-40 years of age\n* Body mass index between 18.5 and 30\n\nExclusion Criteria:\n\n* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)\n* Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension\n* Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism)\n* A personal or family history of epilepsy, seizures or schizophrenia\n* Any known disorders in muscle metabolism\n* Regular use of nutritional supplements\n* Allergy to lidocaine\n* Allergy to one or multiple amino acids\n* Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture) as these could be exacerbated by the intervention e.g. unilateral leg immobilisation, or mean the participant is unable to use crutches.\n* Having received or ingested a stable isotope tracer in the past'}, 'identificationModule': {'nctId': 'NCT03934632', 'briefTitle': 'The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males', 'orgStudyIdInfo': {'id': '180509/B/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Postabsorptive', 'description': 'Saline infusion to mimic postabsorptive circulating amino acid concentrations', 'interventionNames': ['Other: Postabsorptive', 'Procedure: Immobilisation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Postprandial', 'description': 'Amino acid infusion to mimic postprandial circulating amino acid concentrations', 'interventionNames': ['Other: Postprandial', 'Procedure: Immobilisation']}], 'interventions': [{'name': 'Postabsorptive', 'type': 'OTHER', 'description': 'Saline will be infused to mimic postabsorptive circulating amino acid concentrations', 'armGroupLabels': ['Postabsorptive']}, {'name': 'Postprandial', 'type': 'OTHER', 'description': 'An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations', 'armGroupLabels': ['Postprandial']}, {'name': 'Immobilisation', 'type': 'PROCEDURE', 'description': 'One leg will undergo 2 days immobilisation prior to the test day', 'armGroupLabels': ['Postabsorptive', 'Postprandial']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LU', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Marlou Dirks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}