The Effect of Synaquell™ in Contact Sport Athletes

Mayo Clinic

Status: Enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Synaquell(TM); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06104670

23-005242

Details and patient eligibility

About

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

Full description

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Experimental: Synaquell Male Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Synaquell(TM)

Placebo Comparator: Placebo Male Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Experimental: Synaquell Female Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Synaquell(TM)

Placebo Comparator: Placebo Female Group

Placebo Comparator group

Description:

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:

Dietary Supplement: Placebo