Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05692856
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2022-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002976', 'term': 'Clenbuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2023-01-19', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fiber cross-sectional area', 'timeFrame': 'The change in fiber cross-sectional is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Immunohistochemistry to determine fiber cross-sectional area'}, {'measure': 'Myonuclei', 'timeFrame': 'The change in myonuclei is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Immunohistochemistry to determine number of myonuclei'}, {'measure': 'Skeletal muscle proteome', 'timeFrame': 'The change in the muscle proteome is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Pathway enrichment analysis of the muscle proteome using mass-spectrometry based proteomics'}], 'secondaryOutcomes': [{'measure': 'Lean mass', 'timeFrame': 'The change in lean mass is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Lean mass assessed by dual X-ray absorptiometry (DXA)'}, {'measure': 'Isometric muscle strength', 'timeFrame': 'The change in maximal voluntary isometric contraction is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Maximal voluntary isometric contraction of m. quadriceps'}, {'measure': 'Dynamic muscle strength', 'timeFrame': 'The change in 1-repetition maximum is assessed at baseline, 8, 24 and 32 weeks', 'description': '1-repetition maximum'}, {'measure': 'Sprint performance', 'timeFrame': 'The change in sprint performance is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Work performed (W) during a sprint on a bicycle ergometer'}, {'measure': 'Satellite cells', 'timeFrame': 'The change in satellite cells is assessed at baseline, 8, 24 and 32 weeks', 'description': 'Immunohistochemistry to determine number of satellite cells'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skeletal Muscle Physiology']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is investigate muscle memory and underlying mechanisms in humans following resistance training and use of the anabolic substance clenbuterol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* BMI of \\<26 and normal ECG and blood pressure\n\nExclusion Criteria:\n\n* Smoking\n* Chronic disease,\n* Use of prescription medication\n* Pain due to current or previous musculoskeletal injury\n* Resistance training more than once per week in the 12 months leading up to the intervention\n* Current or previous use of prohibited anabolic substances'}, 'identificationModule': {'nctId': 'NCT05692856', 'briefTitle': 'Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans: Myonuclear Addition, Hypertrophy and Myocellular Reprogramming', 'orgStudyIdInfo': {'id': 'CLEN-MEM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clenbuterol', 'description': 'Participants are randomized to daily ingestion of clenbuterol for a period of 8 weeks, with or without supervised resistance training.', 'interventionNames': ['Drug: Clenbuterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants are randomized to daily ingestion of placebo for a period of 8 weeks, with or without supervised resistance training.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clenbuterol', 'type': 'DRUG', 'description': 'Participants ingest 80 micrograms clenbuterol daily during the initial 8-week period. This period is followed by a washout of 16 weeks with no drug and resistance training. Thereafter, an 8-week period with supervised resistance training is commenced, with no drug.', 'armGroupLabels': ['Clenbuterol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants ingest placebo tablets daily during the initial 8-week period. This period is followed by a washout of 16 weeks with no drug and resistance training. Thereafter, an 8-week period with supervised resistance training is commenced, with no drug.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Hostrup', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '+4535321595'}, {'name': 'Lukas Moesgaard, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'August Krogh Building', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Morten Hostrup', 'role': 'CONTACT', 'email': 'mhostrup@nexs.ku.dk', 'phone': '+4535321595'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Hostrup, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}