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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dietary supplement called Synaquell™ can improve brain function in young athletes who play contact sports, such as hockey. Participants will receive either the Synaquell™ supplement or a placebo (a harmless pill that resembles the supplement but contains no active ingredients) to determine any differences in brain health. It is ideal for youth hockey players who are fluent in English and medically cleared to play. As an unphased trial, this study provides a unique opportunity for young athletes to contribute to research that could enhance brain health in sports.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Synaquell supports brain health by increasing cellular energy and controlling inflammation. This enhances brain function and maintains health. It is NSF Certified for Sport, ensuring safety and high quality for athletes.

Although specific side effects are not detailed, Synaquell's availability as a dietary supplement suggests general safety. Such supplements typically undergo thorough testing to ensure public safety. Participants should monitor for any new symptoms and report them to study supervisors.

For those considering a trial with Synaquell, its research and use for brain health can reassure about its safety. However, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Synaquell™ for brain health in athletes because it offers a novel approach compared to traditional treatments for brain injuries, which often focus on rest and symptom management. Unlike standard care, Synaquell™ is a dietary supplement designed to support brain health and potentially enhance recovery in active individuals. This treatment stands out due to its twice-daily oral administration, making it convenient for athletes to use during their seasons. Additionally, Synaquell™ targets specific nutritional pathways to promote brain health, which might provide benefits not seen with current standard care options.

What evidence suggests that Synaquell™ could be effective for brain health in youth contact sport athletes?

Research has shown that Synaquell™ is being studied for its potential to support brain health in athletes who play contact sports. In this trial, male and female youth hockey players will receive either Synaquell™ or a placebo, with separate arms for each gender due to differences in game rules and playing styles. Previous studies have examined Synaquell™'s effects on brain health, particularly in ice hockey players. Although detailed information on its efficacy is limited, the supplement is being tested for its potential to maintain brain health. The special formula of Synaquell™ might protect the brain, but further research is needed to confirm this. ^{1 6 7 8 9}

Who Is on the Research Team?

Mario Hevesi, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

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]

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 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05041192

NCT05041192 | The Effects of Synaquell on Brain Function The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function. Detailed Description. Ice Hockey players will ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06104670

The Effect of Synaquell™ in Contact Sport Athletes This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of ...

3. medrxiv.org medrxiv.org/content/10.1101/2023.04.03.23288079v1.full-text

The effects of a dietary supplement on brain function and ... The primary purpose of this study was to evaluate whether a dietary supplement, SynaquellTM, supports brain function and structure in male ...

4. ctv.veeva.com ctv.veeva.com/study/the-effect-of-synaquell-in-contact-sport-athletes

The Effect of Synaquell™ in Contact Sport Athletes This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players ...

5. withpower.com withpower.com/trial/phase-healthy-subjects-hs-10-2023-f81ce

Synaquell™ for Brain Health in Athletes The available research does not provide specific data supporting the effectiveness of Synaquell™ for Brain Health in Athletes. The studies mentioned focus on ...

6. thorne.com thorne.com/products/dp/synaquell?srsltid=AfmBOooSWSMYMC8kOSgHVMtyPffDUsrqVrtXpEfWZslPX0fnttwYNZIX

SynaQuell™ & Reviews Formulated to support brain health by enhancing cellular energy production and encouraging a healthy balance of inflammatory cytokines.

7. store.mayoclinic.com store.mayoclinic.com/thorne-synaquell-plus.html?srsltid=AfmBOopObj0jpxgy2edD1rEO0hDLRUiWrkL9TXgEpcyu4G2hNzOjPJ3_

Thorne Synaquell + - NSF Certified Thorne Synaquell+ supports post-impact brain health with enhanced cellular energy & cytokine balance. NSF Certified for Sport®. [brain health, energy ...

8. thorne.com thorne.com/products/dp/synaquell-plus?srsltid=AfmBOop-4A3JbY_Zp7sUZI7Cv_aDOraCOQh07F9rGn4Z4pL_tICXowSQ

SynaQuell +™ & Reviews Formulated to support brain health by enhancing cellular energy production and encouraging a healthy balance of inflammatory cytokines.

9. pureprescriptions.com pureprescriptions.com/product/synaquell-thorne/?srsltid=AfmBOorSCdxmgKvfd3pRBdhtHsn66WdpVclm2ccleuJY-DtMKkqQZFsm

SynaQuell Thorne's SynaQuell™ is a research-backed nootropic powder designed to provide foundational, daily support for brain health and cognitive function. This ...