Synaquell™ for Brain Health in Athletes

Overseen By Houston Hawkins

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Hearing issues, Seizures, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Synaquell™ for Brain Health in Athletes is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Synaquell™ for Brain Health in Athletes. The studies mentioned focus on other treatments and conditions, such as cognitive effects of Ginkgo biloba, placebo effects in Parkinson's disease, and cognitive enhancement from energy drinks and stimulants. Without direct evidence from these studies, we cannot conclude that Synaquell™ is effective for brain health in athletes. ^{1 2 3 4 5}

What safety data is available for Synaquell™ used for brain health in athletes?

The provided research does not contain specific safety data for Synaquell™ or its variants. The studies focus on dietary supplements for brain health, WADA prohibited substances, and a different memory-enhancing compound (CL 275,838). None of these directly address the safety of Synaquell™. ^{1 6 7 8 9}

Is Synaquell™ a promising treatment for brain health in athletes?

The information provided does not directly address the effectiveness of Synaquell™ for brain health in athletes. The articles discuss issues with dietary supplements and placebo effects, but do not provide specific evidence supporting Synaquell™ as a promising treatment. ^{2 6 10 11 12}

What is the purpose of this trial?

This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.

Research Team

Mario Hevesi, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am medically approved to participate in contact sports.

Exclusion Criteria

You are allergic to rubbing alcohol or the gel used for EEG tests.

I have a history of seizures.

Implanted pacemaker or defibrillator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Synaquell or placebo twice-daily during the hockey season

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Synaquell(TM)

Trial Overview 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.

Participant Groups

Group I: Experimental: Synaquell Male Group Experimental Treatment 1 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 Group Experimental Treatment 1 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 Group Placebo Group 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Sanford Health

Collaborator

Trials

53

Recruited

2,067,000+

Findings from Research

Acute ingestion of the CRAM supplement helped maintain reaction time and subjective feelings of focus and alertness in physically active subjects after exhaustive exercise, while those on a placebo experienced declines in these measures.

After 4 weeks of supplementation, both groups showed performance declines, suggesting that habituation to the supplement may occur, as indicated by increased fatigue and decreased alertness in the CRAM group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of acute and prolonged CRAM supplementation on reaction time and subjective measures of focus and alertness in healthy college students. Hoffman, JR., Ratamess, NA., Gonzalez, A., et al.[2021]

In a study of 199 early Parkinson's disease patients receiving placebo treatment, 17% showed significant improvements in motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), indicating a notable placebo effect.

The improvements were primarily observed in older patients with more severe motor impairment at baseline, while subjective assessments of daily living activities did not correlate with these objective motor improvements, suggesting that the placebo effect may be more related to rater observations than patient perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-associated improvements in motor function: comparison of subjective and objective sections of the UPDRS in early Parkinson's disease. Goetz, CG., Leurgans, S., Raman, R.[2019]

In a pilot study involving 11 healthy volunteers, the use of multiple crossover n = 1 trials revealed that there are distinct responders and non-responders to the acute nootropic effects of Ginkgo biloba (G. biloba) extract, with 3 individuals identified as potential responders.

The study's design, which included double-blind, placebo-controlled trials with 120 mg doses of G. biloba, demonstrated that some participants consistently performed above chance levels in distinguishing between the active treatment and placebo, suggesting a measurable effect of G. biloba on cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple n = 1 trials in the identification of responders and non-responders to the cognitive effects of Ginkgo biloba. Canter, PH., Ernst, E.[2019]

In a study involving 32 college students, the use of mixed amphetamine salts (Adderall™) did not significantly enhance cognitive performance compared to a placebo, with only minor improvements observed on two out of 31 cognitive tests.

Expectations played a crucial role in performance; participants who believed they received the stimulant performed better on some tasks, while those expecting a placebo performed worse, highlighting the strong influence of psychological factors over actual pharmacological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed-amphetamine salts expectancies among college students: Is stimulant induced cognitive enhancement a placebo effect? Cropsey, KL., Schiavon, S., Hendricks, PS., et al.[2018]

In a study involving 24 healthy young volunteers, the regular Red Bull energy drink significantly improved cognitive function, particularly in working and episodic memory, compared to both the Sugarfree version and a placebo.

The improvements in memory were substantial, with a medium effect size indicating that Red Bull can enhance cognitive performance in young individuals shortly after consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Red Bull energy drink on cognitive function and mood in healthy young volunteers. Wesnes, KA., Brooker, H., Watson, AW., et al.[2018]

A review of 12 dietary supplements marketed for brain health revealed that 67% had ingredients listed on their labels that were not detected in the actual product, indicating potential misbranding.

Additionally, 83% of the products contained compounds that were not reported on the labels, and many scientific claims made by these products lacked scientific support, highlighting the need for consumer education and regulatory improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. Crawford, C., Boyd, C., Avula, B., et al.[2021]

Only 5 out of 23 substance classes on the World Anti-Doping Agency's Prohibited List have shown evidence of enhancing sports performance in trained athletes, specifically anabolic agents, β2-agonists, stimulants, glucocorticoids, and β-blockers.

The evidence for performance enhancement is limited, with only 266 subjects across 11 studies providing data, and no substances demonstrating positive effects on endurance performance, highlighting a lack of convincing evidence for most substance classes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of WADA Prohibited Substances: Limited Evidence for Performance-Enhancing Effects. Heuberger, JAAC., Cohen, AF.[2020]

A survey of elite athletes from Australia, Canada, the UK, and the USA revealed that they have limited knowledge about over-the-counter (OTC) medications, with only 35.1% correctly identifying the status of substances on the WADA Prohibited List.

Despite recognizing the health risks and performance-enhancing potential of OTC stimulants, athletes were uncertain about whether these substances should be banned again, highlighting the need for targeted education programs to help them make informed decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Athletes' knowledge and views on OTC medication. Mottram, D., Chester, N., Atkinson, G., et al.[2015]

In a study involving 16 healthy male volunteers, the new memory-enhancing compound CL 275,838 showed a dose-related increase in plasma concentrations after 14 daily doses, indicating its pharmacokinetics are predictable and consistent.

The compound and its metabolites were well-tolerated, with no significant safety concerns noted during cognitive tests, suggesting potential for therapeutic action in enhancing memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple-dose pharmacokinetics and safety of a potential memory-enhancing compound, CL 275,838, in healthy male volunteers. Caccia, S., Confalonieri, S., Guiso, G., et al.[2019]

In a study involving 24 normal adults, Ginkgo biloba extract was found to significantly improve short-term working memory processing, as indicated by a 50 ms decrease in response time compared to a placebo.

The study utilized a double-blind design and a computerized test battery over 14 days, ensuring that the results were reliable and minimizing variability in performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive effects of a Ginkgo biloba/vinpocetine compound in normal adults: systematic assessment of perception, attention and memory. Polich, J., Gloria, R.[2019]

In a randomized, double-blind, placebo-controlled trial involving 63 healthy adults aged 18 to 35, Alpha BRAIN® significantly improved delayed verbal recall and executive functioning compared to a placebo over a 6-week period.

The study suggests that Alpha BRAIN® can enhance recent verbal memory in healthy individuals, but further research is needed to confirm these findings as this is the first randomized controlled trial of the supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally. Solomon, TM., Leech, J., deBros, GB., et al.[2016]

A study involving 61 experienced gamers showed that both acute and 30-day supplementation with a microalgae extract containing fucoxanthin and guarana improved cognitive functions such as reaction times, reasoning, and attention shifting.

The most significant cognitive benefits were observed after 30 days of supplementation, suggesting that long-term use may enhance not only cognitive performance but also mood states in gamers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dietary Supplementation of a Microalgae Extract Containing Fucoxanthin Combined with Guarana on Cognitive Function and Gaming Performance. Leonard, M., Maury, J., Dickerson, B., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of acute and prolonged CRAM supplementation on reaction time and subjective measures of focus and alertness in healthy college students. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Placebo-associated improvements in motor function: comparison of subjective and objective sections of the UPDRS in early Parkinson's disease. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Multiple n = 1 trials in the identification of responders and non-responders to the cognitive effects of Ginkgo biloba. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Mixed-amphetamine salts expectancies among college students: Is stimulant induced cognitive enhancement a placebo effect? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of the Red Bull energy drink on cognitive function and mood in healthy young volunteers. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Review of WADA Prohibited Substances: Limited Evidence for Performance-Enhancing Effects. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Athletes' knowledge and views on OTC medication. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Multiple-dose pharmacokinetics and safety of a potential memory-enhancing compound, CL 275,838, in healthy male volunteers. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cognitive effects of a Ginkgo biloba/vinpocetine compound in normal adults: systematic assessment of perception, attention and memory. [2019]

11. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Dietary Supplementation of a Microalgae Extract Containing Fucoxanthin Combined with Guarana on Cognitive Function and Gaming Performance. [2023]