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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 below

Select...

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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, postseason (approximately 6 months). for reporting.

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 more

Secondary outcome measures

Change in King-Devick Test (KDT) scored

Impact Monitor Mouthguard Acceleration

Impact Monitor Mouthguard Head Impacts

+1 more

Trial 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,448 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to senior citizens over the age of 75?

"This medical trial's eligibility requirements dictate that all participants must be over the age of 13 and under 19."

Answered by AI

Is there an open call for participants to join this experiment?

"According to the information on clinicaltrials.gov, recruitment for this particular trial has been suspended since October 25th 2023; evidence of its first posting being November 1st 2023. Fortunately, there are 841 other medical studies actively seeking participants at present."

Answered by AI

What are the desired outcomes of this investigation?

"The main result that this clinical trial seeks to determine is the alteration in N100 Latency over baseline and 6 months post-treatment. Additionally, secondary objectives involve measuring head acceleration, rotation of the head, and number of impacts with an Impact Monitor Mouthguard device."

Answered by AI

To what criteria must participants adhere in order to join this clinical trial?

"To be eligible for this trial, subjects should possess general health and fall between the age range of 13 and 19. A total of 40 volunteers are sought out."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Synaquell™ in Contact Sport Athletes

Mario Hevesi 2023. "The Effect of Synaquell™ in Contact Sport Athletes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104670.