What side effects are associated with this type of intervention?

Common treatments for nutritional support of brain function, such as omega-3 fatty acids and other dietary supplements, generally have mild side effects. For example, omega-3 fatty acids may cause gastrointestinal issues like nausea, diarrhea, and fishy aftertaste. Other supplements, like CoQ10, have been associated with mild adverse effects such as stomach upset, loss of appetite, and skin rashes. Overall, these treatments are well-tolerated in healthy subjects, with serious adverse events being rare.

What prior FDA approvals exist?

The FDA has approved various nutritional supplements and cognitive enhancers aimed at supporting brain function in healthy individuals. These include omega-3 fatty acids, B vitamins, and antioxidants, which are commonly found in over-the-counter supplements. Additionally, nootropic agents like caffeine and certain amino acids (e.g., L-theanine) are recognized for their cognitive benefits. While specific FDA approvals for treatments exactly like Synaquell (TM) are not detailed, these general categories of supplements are widely used to support brain health and cognitive function in healthy subjects.

What other types of research exist?

Promising alternatives to Synaquell (TM) for nutritional support of brain function in healthy subjects include: 1) Omega-3 fatty acids (e.g., fish oil) which have been studied for their role in cognitive health and neuroprotection. 2) Ginseng, which has shown potential benefits in improving cognitive function and reducing fatigue. 3) Transcranial Magnetic Stimulation (TMS), a non-invasive neuromodulation technique that has shown promise in enhancing cognitive performance. These alternatives have been supported by various studies and clinical trials, indicating their potential efficacy in supporting brain function.

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Dietary Supplement

Synaquell for Brain Function in Athletes

N/A

Waitlist Available

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, postseason (approximately 6 months)

Summary

This trial is testing if the brain health supplement Synaquell can improve brain function in youth ice hockey players. The study will compare results from those taking Synaquell and others over several months using different brain health tests.

Who is the study for?

This trial is for medically cleared youth ice hockey players who speak English fluently. It's not suitable for those with pacemakers, defibrillators, in-ear hearing devices, skull implants, seizure history or allergies to SynaquellTM ingredients, rubbing alcohol or EEG gel.

What is being tested?

The study tests the effects of a dietary supplement called Synaquell(TM) on brain function in these athletes. Participants will either receive Synaquell(TM) or a placebo without knowing which one they are taking.

What are the potential side effects?

Potential side effects aren't specified but may relate to individual sensitivity to the ingredients of Synaquell(TM) or the placebo used in this research.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in N100 Amplitude

Change in N100 Latency

Change in N400 Amplitude

+4 more

Secondary study objectives

Change in King-Devick Test (KDT) scores

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 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: 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 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 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Synaquell

2021

N/A

~140

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nutritional supplements like Synaquell (TM) typically contain vitamins, minerals, and bioactive compounds that support brain health by enhancing cognitive function, protecting against oxidative stress, and improving brain metabolism. These mechanisms are important for healthy subjects as they help maintain optimal brain function, prevent cognitive decline, and enhance mental performance.

Potential role of phytochemicals in metabolic syndrome prevention and therapy.