Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
Study NCT ID:
NCT05041192
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Synaquell on Brain Function
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']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in brain vital signs', 'timeFrame': 'Baseline, Postseason (approximately 6 months)', 'description': 'Obtained by EEG recording of N100, P300, N400 amplitudes and latencies. Increased amplitudes are indicative of larger signals and increased latencies are indicative of slower responses.'}, {'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 cards a loud as fast as possible, the resulting time is the KDT score.'}]}, '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': 'The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.', 'detailedDescription': 'Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or greater.\n* Fluent English speakers.\n* Medically cleared to play ice hockey.\n\nExclusion Criteria:\n\n* An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).\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.\n* Unhealthy scalp.'}, 'identificationModule': {'nctId': 'NCT05041192', 'briefTitle': 'The Effects of Synaquell on Brain Function', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players', 'orgStudyIdInfo': {'id': '21-004746'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synaquell Group', 'description': 'Subjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season.', 'interventionNames': ['Dietary Supplement: Synaquell']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects will receive the placebo twice-daily, during the hockey season.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Synaquell', 'type': 'DIETARY_SUPPLEMENT', 'description': '7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).', 'armGroupLabels': ['Synaquell Group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).', 'armGroupLabels': ['Placebo 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 J Stuart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'HealthTech Connex Inc.', 'class': 'INDUSTRY'}, {'name': 'Thorne HealthTech, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael J. Stuart', 'investigatorAffiliation': 'Mayo Clinic'}}}}