Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-31 @ 2:47 PM
Study NCT ID:
NCT06371651
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creatine and GAA for Brain Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-04-14', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain oxygen saturation', 'timeFrame': 'Change from baseline brain oxygen saturation at 2 weeks', 'description': 'Percentage of oxygen saturation in prefrontal brain'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin index', 'timeFrame': 'Change from baseline hemoglobin index at 2 weeks', 'description': 'Concentration of hemoglobin index in prefrontal brain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['creatine', 'guanidinoacetic acid', 'oxygen saturation', 'brain'], 'conditions': ['Oxygen Deficiency']}, 'referencesModule': {'references': [{'pmid': '11985880', 'type': 'BACKGROUND', 'citation': 'Watanabe A, Kato N, Kato T. Effects of creatine on mental fatigue and cerebral hemoglobin oxygenation. Neurosci Res. 2002 Apr;42(4):279-85. doi: 10.1016/s0168-0102(02)00007-x.'}, {'pmid': '20570601', 'type': 'BACKGROUND', 'citation': 'Hammett ST, Wall MB, Edwards TC, Smith AT. Dietary supplementation of creatine monohydrate reduces the human fMRI BOLD signal. Neurosci Lett. 2010 Aug 2;479(3):201-5. doi: 10.1016/j.neulet.2010.05.054. Epub 2010 May 24.'}, {'pmid': '39569437', 'type': 'DERIVED', 'citation': 'Zanini D, Todorovic N, Ostojic SM. Creatine with guanidinoacetic acid improves prefrontal brain oxygenation before, during, and after a cognitive task: A randomized controlled pilot trial. Nutr Health. 2025 Jun;31(2):363-368. doi: 10.1177/02601060241300236. Epub 2024 Nov 21.'}], 'seeAlsoLinks': [{'url': 'https://www.appliedbioenergetics.org/', 'label': 'Web page of study lab'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-30 years\n* Absence of metabolic disorders or other health complications\n* Provision of signed informed consent\n\nExclusion Criteria:\n\n* History of dietary supplement use within the preceding 4 weeks\n* Lack of consent to randomization\n* Concurrent participation in other studies'}, 'identificationModule': {'nctId': 'NCT06371651', 'acronym': 'CREGAA-OXY', 'briefTitle': 'Creatine and GAA for Brain Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'University of Novi Sad, Faculty of Sport and Physical Education'}, 'officialTitle': 'Enhancing Brain Oxygenation: Effects of Short-Term Co-Administration of Creatine and Guanidinoacetic Acid at Rest and During Stress', 'orgStudyIdInfo': {'id': '23-1462-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplement', 'description': 'One sachet of supplement before breakfast and dinner', 'interventionNames': ['Dietary Supplement: Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One sachet of inert compound before breakfast and dinner', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplement containing creatine and guanidinoacetic acid', 'armGroupLabels': ['Supplement']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Inert substance', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Novi Sad', 'state': 'Vojvodina', 'country': 'Serbia', 'facility': 'Applied Bioenergetics Lab at Faculty of Sport and PE', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Sergej Ostojic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Novi Sad'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in nutritional neuroscience. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Only qualified researchers with academic interest in in nutritional neuroscience'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Novi Sad, Faculty of Sport and Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sergej Ostojic', 'investigatorAffiliation': 'University of Novi Sad, Faculty of Sport and Physical Education'}}}}