Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-03 @ 7:24 AM
Study NCT ID:
NCT03147833
Status:
COMPLETED
Last Update Posted:
2018-06-11
First Post:
2017-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Before Night Sleep to Improve Recovery and Performance in Runners
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance', 'timeFrame': '8 days', 'description': '5 km time trial'}], 'secondaryOutcomes': [{'measure': 'Muscle damage', 'timeFrame': '8 days', 'description': 'creatine kinase'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: VO2max \\>55 ml O2/kg/min -\n\nExclusion Criteria:women, smokers\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03147833', 'briefTitle': 'Protein Before Night Sleep to Improve Recovery and Performance in Runners', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Ingestion of Protein Before Each Night Sleep to Improve Recovery and Performance in Runners', 'orgStudyIdInfo': {'id': '1107229216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sport beverages Protein', 'description': 'Intervention group ingesting PROTEIN', 'interventionNames': ['Dietary Supplement: Sport beverages Protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sports beverage Carbohydrate', 'description': 'Placebo group ingesting carbohydrate', 'interventionNames': ['Dietary Supplement: Sport beverages Carbohydrate']}], 'interventions': [{'name': 'Sport beverages Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverage ingested before each night sleep during the intervention', 'armGroupLabels': ['Sport beverages Protein']}, {'name': 'Sport beverages Carbohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Beverage ingested before each night sleep during the intervention', 'armGroupLabels': ['Sports beverage Carbohydrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University, Department for Public Health, Section for Sport Science', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Mette Hansen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mette Hansen', 'investigatorAffiliation': 'University of Aarhus'}}}}