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Synaquell™ for Brain Health in Athletes
N/A
Recruiting
Led By Michael Stuart, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fluent English Speakers
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, postseason (approximately 6 months).
Awards & highlights
Study Summary
This trial looks at if a dietary supplement helps protect youth athletes' brain health.
Who is the study for?
This trial is for young athletes who speak English, are medically cleared to play contact sports, and have no allergies to Synaquell™ or placebo ingredients. It's not for those with pacemakers, hearing issues, skull implants, seizure history, or allergies to certain cleaning substances.Check my eligibility
What is being tested?
The study tests the effects of a dietary supplement called Synaquell™ on brain function in youth athletes playing contact sports. Participants will either receive Synaquell™ or a placebo without knowing which one they're taking.See study design
What are the potential side effects?
Potential side effects aren't specified but could relate to known allergies to the ingredients in Synaquell™ or the placebo. Participants should report any unusual symptoms they experience during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English fluently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, postseason (approximately 6 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, postseason (approximately 6 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in N100 Amplitude
Change in N100 Latency
Change in N400 Amplitude
+8 moreSecondary outcome measures
Change in King-Devick Test (KDT) scored
Impact Monitor Mouthguard Acceleration
Impact Monitor Mouthguard Head Impacts
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Synaquell Male GroupExperimental Treatment1 Intervention
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.
Group II: Experimental: Synaquell Female GroupExperimental Treatment1 Intervention
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.
Group III: Placebo Comparator: Placebo Male GroupPlacebo Group1 Intervention
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.
Group IV: Placebo Comparator: Placebo Female GroupPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,253 Previous Clinical Trials
3,835,357 Total Patients Enrolled
Sanford HealthOTHER
48 Previous Clinical Trials
61,883 Total Patients Enrolled
Michael Stuart, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
4,141 Total Patients Enrolled
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