MedPath

The Effects of Synaquell on Brain Function

Not Applicable
Completed
Conditions
Healthy
Interventions
Dietary Supplement: Placebo
Dietary Supplement: Synaquell
Registration Number
NCT05041192
Lead Sponsor
Mayo Clinic
Brief Summary

The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.

Detailed Description

Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
54
Inclusion Criteria
  • 18 years of age or greater.
  • Fluent English speakers.
  • Medically cleared to play ice hockey.
Read More
Exclusion Criteria
  • An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).
  • 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.
  • Unhealthy scalp.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo GroupPlaceboSubjects will receive the placebo twice-daily, during the hockey season.
Synaquell GroupSynaquellSubjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season.
Primary Outcome Measures
NameTimeMethod
Change in brain vital signsBaseline, Postseason (approximately 6 months)

Obtained by EEG recording of N100, P300, N400 amplitudes and latencies. Increased amplitudes are indicative of larger signals and increased latencies are indicative of slower responses.

Change in blood biomarkerBaseline, Postseason (approximately 6 months)

Neurofilament light chain (NfL) blood serum levels.

Secondary Outcome Measures
NameTimeMethod
Change in King-Devick Test (KDT) scoresBaseline, Postseason (approximately 6 months)

A rapid number-naming test that requires individuals to read 3 numbered cards a loud as fast as possible, the resulting time is the KDT score.

Trial Locations

Locations (1)

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath