Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-01 @ 3:18 PM
Study NCT ID:
NCT06167395
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Analyze the Aerobic Performance Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015091', 'term': 'beta-Alanine'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000409', 'term': 'Alanine'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2023-12-02', 'studyFirstSubmitQcDate': '2023-12-09', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Power', 'timeFrame': 'Change in performance after 30 days of product consumption', 'description': 'Measured using a cyclus 2 roller.'}, {'measure': 'Distance', 'timeFrame': 'Change in performance after 30 days of product consumption', 'description': 'Measured using a cyclus 2 roller.'}], 'secondaryOutcomes': [{'measure': 'Anaerobic treshold', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'Through a stress test with gas analysis'}, {'measure': 'Maximum oxygen consumption', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'Through a stress test with gas analysis'}, {'measure': 'Aerobic threshold', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'Through a stress test with gas analysis'}, {'measure': 'Microcapillary blood', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.'}, {'measure': 'Lactate', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'Lactate levels will be measured using the Lactate Pro 2'}, {'measure': 'Heart Rate', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'The heart rate will be evaluated by means of a heart rate strap.'}, {'measure': 'Fatigue', 'timeFrame': 'It will be measured twice, once at baseline or at the end of the study after 30 days.', 'description': 'Rate of perceived exertion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aerobic Performance', 'Beta Alanine', 'Supplementation'], 'conditions': ['Beta Alanine Supplementation']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational cyclist', 'detailedDescription': 'Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).\n\nThe product to be consumed is beta alanine. Participants will consume the product for 30 days. They will have to take 4 intakes every three hours, being the first intake two hours after waking up.\n\nThe study subjects will have to make 2 visits to the laboratory. At the first and last visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male cyclists with more than two years of cycling experience.\n* Perform tests without fatigue.\n* Road bike training at least twice a week.\n\nExclusion Criteria:\n\n* Participants with chronic illness.\n* Have a long-term injury that prevents you from training in the previous month.\n* Inability to understand informed consent.\n* Have consumed beta alanine in the three years prior to the start of the study.\n* Consumption of other supplements that may alter performance.'}, 'identificationModule': {'nctId': 'NCT06167395', 'acronym': 'B-AC3', 'briefTitle': 'Study to Analyze the Aerobic Performance Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Randomized Clinical Trial to Analyze the Efficacy of Chronic Intake of Different Doses of a β-alanine Supplement on Aerobic Performance in Recreational Long-Distance Road Cyclists', 'orgStudyIdInfo': {'id': 'UCAMCFE-00031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta Alanine high dose', 'description': 'Consumption for 30 days.', 'interventionNames': ['Dietary Supplement: Beta Alanine high dose']}, {'type': 'EXPERIMENTAL', 'label': 'Beta Alanine low dose', 'description': 'Consumption for 30 days.', 'interventionNames': ['Dietary Supplement: Beta Alanine low dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Consumption for 30 days.', 'interventionNames': ['Dietary Supplement: Control product']}], 'interventions': [{'name': 'Beta Alanine high dose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects should consume 4 intakes of 5 g of beta alanine every 3 hours each day.', 'armGroupLabels': ['Beta Alanine high dose']}, {'name': 'Beta Alanine low dose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects should consume 4 intakes of 2,5 g of beta alanine every 3 hours each day.', 'armGroupLabels': ['Beta Alanine low dose']}, {'name': 'Control product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects should consume 4 intakes of 2,5 g of wheat semolina every 3 hours each day.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Catholic University of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francisco Javier López Román', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}