Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT02604927
Status:
UNKNOWN
Last Update Posted:
2015-11-16
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015091', 'term': 'beta-Alanine'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D000409', 'term': 'Alanine'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-11', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-11-11', 'lastUpdatePostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise performance (Time to exhaustion test)', 'timeFrame': '28 days', 'description': 'Time to exhaustion test performed on arm crank ergometer'}, {'measure': 'Muscle carnosine content before and after supplementation', 'timeFrame': '28 days', 'description': 'Assessed by muscle biopsy samples before performance tests'}], 'secondaryOutcomes': [{'measure': 'Muscle carnosine content in trained (deltoid) vs. untrained (vastus lateralis) muscles', 'timeFrame': '28 days', 'description': 'Deltoids microbiopsy and vastus lateralis biopsy'}, {'measure': 'Blood pH.', 'timeFrame': '5 minutes after performance tests', 'description': '1 mL venous blood sample'}, {'measure': 'Safety of beta-alanine supplementation measured by complete hemogram analysis', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines. Previous studies from our group have shown that upper-body exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional supplements capable of increasing buffering capacity. In line with this, have shown that upper-body muscle groups benefit more from artificially induced alkalosis than lower-body muscle groups. Although β-alanine appears to be an interesting and potential ergogenic supplement for paralympians, no study to date has assessed its potential in wheelchair athletes.In this study, we will evaluate the effects of β-alanine supplementation on upper-body performance in wheelchair athletes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paralympian training for any exercise modality for at least one year;\n* A weekly training volume of 6 hours or more;\n* Have a spinal cord injury accompanied by loss of motor function in the lower limbs for at least one year;\n* Available for carrying out the experimental procedures.\n\nExclusion Criteria:\n\n* Use of creatine or beta-alanine for at least 3 and 6 months before the trial;\n* Cardiovascular or respiratory disease;\n* Clinical condition that result in malabsorption of nutrients;\n* Any other medical condition that prevents the realization of experimental procedures.'}, 'identificationModule': {'nctId': 'NCT02604927', 'briefTitle': 'Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'orgStudyIdInfo': {'id': 'B-Alanine Paraplegic Athletes'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '800 mg of dextrose, four times per day, during 28 days.', 'interventionNames': ['Dietary Supplement: Dextrose']}, {'type': 'EXPERIMENTAL', 'label': 'Beta-alanine', 'description': '800 mg of beta-alanine, four times per day, during 28 days.', 'interventionNames': ['Dietary Supplement: Beta-alanine']}], 'interventions': [{'name': 'Beta-alanine', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beta-alanine']}, {'name': 'Dextrose', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Guilherme Artioli, PhD', 'role': 'CONTACT', 'email': 'artioli@usp.br', 'phone': '55 11 3091-3096'}], 'facility': 'School of Physical Education and Sports, University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Guilherme Artioli, PhD', 'role': 'CONTACT', 'email': 'artioli@usp.br', 'phone': '55 11 30913096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}