Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05498818
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Synaquell on Brain Function of Ice Hockey Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The study staff responsible for preparing and distributing SynaquellTM will not be blinded to the intervention, but all subjects and other study staff will be blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in N100 Amplitude', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.'}, {'measure': 'Change in N100 Latency', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.'}, {'measure': 'Change in P300 Amplitude', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of P300 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.'}, {'measure': 'Change in P300 Latency', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.'}, {'measure': 'Change in N400 Amplitude', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of N400 potential amplitude. Increased amplitudes are indicative of larger signals.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.'}, {'measure': 'Change in N400 Latency', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of N400 potential latency. Increased latencies are indicative of slower responses.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.'}, {'measure': 'Change in blood biomarker', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Neurofilament light chain (NfL) blood serum levels'}], 'secondaryOutcomes': [{'measure': 'Change in King-Devick Test (KDT) scores', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'A rapid number-naming test that requires individuals to read 3 numbered patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ice Hockey', 'Cognitive Function', 'Cognition', 'Brain', 'Supplement', 'Contact Sport Athletes'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.', 'detailedDescription': 'This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King Devick).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent English speakers\n* Medically cleared to play ice hockey\n\nExclusion Criteria:\n\n* An allergy to the ingredients of SynaquellTM or the placebo\n* Clinically documented hearing issues,\n* In-ear hearing aid or cochlear implant\n* Implanted pacemaker or defibrillator\n* Metal or plastic implants in skull\n* Lack of verbal fluency in the English language\n* History of seizures\n* Allergy to rubbing alcohol or EEG gel'}, 'identificationModule': {'nctId': 'NCT05498818', 'briefTitle': 'The Effects of Synaquell on Brain Function of Ice Hockey Players', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Effect of Synaquell on Objective Brain Function Measures in Youth Ice Hockey Players', 'orgStudyIdInfo': {'id': '22-003414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synaquell Male Group', 'description': 'Male youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol.', 'interventionNames': ['Dietary Supplement: Synaquell']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Male Group', 'description': 'Male youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Synaquell Female Group', 'description': 'Female youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol.', 'interventionNames': ['Dietary Supplement: Synaquell']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Female Group', 'description': 'Female youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Synaquell', 'type': 'DIETARY_SUPPLEMENT', 'description': '7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).', 'armGroupLabels': ['Synaquell Female Group', 'Synaquell Male Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.', 'armGroupLabels': ['Placebo Female Group', 'Placebo Male Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael Stuart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ORRS Owner', 'investigatorAffiliation': 'Mayo Clinic'}}}}