The Effect of Synaquell™ in Contact Sport Athletes

NCT ID: NCT06104670

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2026-07-31

Brief Summary

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

Detailed Description

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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 an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood \& saliva biomarkers, impact monitoring mouthguard, and a rapid number naming test (King Devick).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
The study staff responsible for distributing SynaquellTM will not be blinded to the intervention, but all subjects and other study staff will be blinded.

Study Groups

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Experimental: Synaquell Male Group

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 Type EXPERIMENTAL

Synaquell(TM)

Intervention Type DIETARY_SUPPLEMENT

7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).

Placebo Comparator: Placebo Male Group

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 Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.

Experimental: Synaquell Female Group

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 Type EXPERIMENTAL

Synaquell(TM)

Intervention Type DIETARY_SUPPLEMENT

7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).

Placebo Comparator: Placebo Female Group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.

Interventions

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Synaquell(TM)

7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).

Intervention Type DIETARY_SUPPLEMENT

Placebo

7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Fluent English Speakers
* Medically cleared to play contact sport

Exclusion Criteria

* An allergy to the ingredients of Synaquell™ or the placebo (ingredients listed on page
* Clinically documented hearing issues,
* In-ear hearing aid or cochlear implant
* Implanted pacemaker or defibrillator
* Metal or plastic implants in skull
* Lack of verbal fluency in the English language
* History of seizures
* Allergy to rubbing alcohol or EEG gel
* Pregnancy
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanford Health

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mario Hevesi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Hevesi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Houston Hawkins

Role: CONTACT

507-293-3295

Facility Contacts

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Houston Hawkins

Role: primary

507-293-3295

Other Identifiers

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23-005242

Identifier Type: -

Identifier Source: org_study_id

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