Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-29 @ 7:15 AM
Study NCT ID:
NCT06138951
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Dose-response and Protein Requirements
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phenylalanine excretion', 'timeFrame': '8 hours', 'description': 'Excretion of 13CO2 in the breath will be used to estimate the impact of exercise on daily protein requirements. This outcome will include the enrichment of 13CO2 in exhaled breath after the ingestion of \\[13C\\]phenylalanine tracer and the production of CO2 determined by indirect calorimetry at rest or after exercise.'}], 'secondaryOutcomes': [{'measure': 'Phenylalanine flux', 'timeFrame': '8 hours', 'description': 'The enrichment of \\[13C\\]phenylalanine in the urine will be used to estimate the flux of phenylalanine in the body at rest or after exercise.'}, {'measure': 'Phenylalanine oxidation', 'timeFrame': '8 hours', 'description': 'The oxidation of \\[13C\\]phenylalanine will be determined by correcting phenylalanine excretion by phenylalanine flux.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Training']}, 'descriptionModule': {'briefSummary': 'Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy, male, endurance-trained participants who regularly run more than 40 km/week or perform endurance exercise for more than 4.5 hours/week\n\n* Participants who have a self-reported 5-km run time of ≤23 min\n* Participants who are categorized as at least "very good" based on a study by Shvartz \\& Reibold (Aviat Space Environ Med. 1990 Jan;61(1):3-11), in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)\n* Ability to complete the 16-km familiarization run on Session 2\n* Aged 18-40 years old\n\nExclusion Criteria:\n\n* \\- Inability to meet health and physical activity guidelines according to the PAR-Q+.\n* Female: hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence specific amino acid requirements at rest; as such, the present study will test the effect of endurance exercise on protein requirements in males only to ensure a stable hormonal environment and to increase the homogeneity of the physiological response. (NOTE: we plan to test females in a future trial based off of the results obtained herein)\n* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)\n* Regular tobacco use\n* Illicit drug use (e.g. growth hormone, testosterone, etc.)'}, 'identificationModule': {'nctId': 'NCT06138951', 'briefTitle': 'Exercise Dose-response and Protein Requirements', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Dose Response Effect of Endurance Exercise on Protein Requirements of Endurance Athletes', 'orgStudyIdInfo': {'id': 'DRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Nonexercised rested day', 'description': 'Athlete will not exercise on trial day.', 'interventionNames': ['Other: Endurance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Recovery from 10KM run', 'description': 'Athlete will run 10km on trial day.', 'interventionNames': ['Other: Endurance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Recovery from 20KM run', 'description': 'Athlete will run 20km on trial day.', 'interventionNames': ['Other: Endurance exercise']}], 'interventions': [{'name': 'Endurance exercise', 'type': 'OTHER', 'description': 'On the trial day before commencing the indicator amino acid oxidation metabolic trial, participants will either rest, perform a 10km run on a treadmill, or perform a 20km run on a treadmill.', 'armGroupLabels': ['Nonexercised rested day', 'Recovery from 10KM run', 'Recovery from 20KM run']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S2C9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Goldring Centre for High Performance Sport at the University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Moore', 'investigatorAffiliation': 'University of Toronto'}}}}