Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04850820
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2021-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Amino Acids to Enhance Anabolism After Home-based Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All investigators involved with the study, as well as participants, will be blinded to treatment conditions (double-blind design) until data analysis is completed.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In a randomized, counterbalanced order, participants will receive all treatments arms (essential amino acids, branched-chain amino acids, and placebo).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2021-04-17', 'studyFirstSubmitQcDate': '2021-04-17', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-body net leucine balance (umol/kg)', 'timeFrame': '5 hours/trial (four trials total)', 'description': 'Used as a proxy of whole-body protein balance, and estimated by using \\[13C\\]leucine ingestion and breath/urine sample collection'}], 'secondaryOutcomes': [{'measure': 'Urinary 3-methylhistidine (3-methylhistidine:creatinine ratio)', 'timeFrame': '5 hours/trial (four trials total)', 'description': 'Used as a marker of muscle protein breakdown by measuring the 3-methylhistidine:creatinine ratio in the urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Home-based resistance exercise', 'Protein synthesis', 'Net protein balance', 'Protein breakdown', 'Essential amino acids', 'Branched-chain amino acids', 'Protein metabolism'], 'conditions': ['Amino Acids, Essential', 'Metabolism', 'Exercise']}, 'descriptionModule': {'briefSummary': 'An adequate quantity of lean body mass is vital for optimal health and performance, and is accrued when net protein balance (NPB) is positive. Amino acids are the building blocks of protein, and when consumed following resistance exercise, significantly improve NPB.\n\nHowever, no study has investigated how a supplement of all of the essential amino acids (EAA) affects NPB following resistance exercise in a free-living, home-based setting, particularly when compared to a supplement of branched-chain amino acids (BCAA).\n\nTherefore, the purpose of this study is to determine the impact of a novel EAA supplement on anabolism (e.g., NPB) as compared to BCAA and placebo supplements following home-based resistance exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-35 years\n* Recreationally active; currently performing structured exercise (e.g., running, weight lifting, team-sport activity) at least 2 days per week\n\nExclusion Criteria:\n\n* Body Mass Index: \\>29.9kg/m\\^2\n* Inability to perform physical activity as determined by the Physical Activity Readiness Questionnaire\n* Inability to adhere to protocol guidelines (e.g., alcohol, habitual diet)\n* Regular tobacco use\n* Illicit drug use (e.g., growth hormone, testosterone)\n* Diagnosed medical condition under the care of a physician\n* Inability to abstain from supplements (e.g., protein, creatine, HMB, BCAA, phosphatidic acid) at least three weeks before and during trials\n* Individuals on any medications known to affect protein metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)'}, 'identificationModule': {'nctId': 'NCT04850820', 'acronym': 'B2B', 'briefTitle': 'Impact of Amino Acids to Enhance Anabolism After Home-based Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Impact of Amino Acids to Enhance Anabolism After Home-based Exercise', 'orgStudyIdInfo': {'id': 'B2B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Novel essential amino acid supplementation (EAA+)', 'description': 'Arm will investigate the effect of a novel essential amino acid-based formula (essential amino acids enriched with active botanical compounds; EAA+) developed by Iovate Health Sciences International Inc. on post-exercise anabolism. The formulation was recently granted a Natural Product Number (NPN: 80087022) and approved by the Natural and Non-prescription Health Products Directorate of Health Canada.', 'interventionNames': ['Dietary Supplement: Novel essential amino acid supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Branched-chain amino acid supplementation (BCAA)', 'description': 'Arm will used a branched-chain amino acid supplement developed by Iovate Health Sciences International Inc. to compare with the experimental arm after exercise.', 'interventionNames': ['Dietary Supplement: Branched-chain amino acid supplementation (BCAA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isocaloric carbohydrate supplementation', 'description': 'Carbohydrate supplement that is isocaloric to the EAA+ supplement and designed to function as a placebo to the experimental arm after exercise.', 'interventionNames': ['Dietary Supplement: Isocaloric carbohydrate supplementation']}, {'type': 'OTHER', 'label': 'Rested control', 'description': 'Carbohydrate supplement that is isocaloric to the EAA+ supplement but consumed at rest to serve as the baseline control', 'interventionNames': ['Dietary Supplement: Isocaloric carbohydrate supplementation']}], 'interventions': [{'name': 'Novel essential amino acid supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This intervention will determine the impact of EAA+ on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.', 'armGroupLabels': ['Novel essential amino acid supplementation (EAA+)']}, {'name': 'Branched-chain amino acid supplementation (BCAA)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This intervention will determine the impact of the BCAA supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.', 'armGroupLabels': ['Branched-chain amino acid supplementation (BCAA)']}, {'name': 'Isocaloric carbohydrate supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This intervention will determine the impact of an isocaloric carbohydrate placebo supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.', 'armGroupLabels': ['Isocaloric carbohydrate supplementation', 'Rested control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S2C9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Goldring Centre for High Performance Sport', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Daniel Moore', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iovate Health Sciences International Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Moore', 'investigatorAffiliation': 'University of Toronto'}}}}