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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Healthy

Age range

18 year–21 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or greater.
  • Fluent English speakers.
  • Medically cleared to play ice hockey.

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.

Treatment and study plan

Synaquell

Dietary Supplement

7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).

Placebo

Dietary Supplement

7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).

Primary outcomes

  1. Change in brain vital signs

    Time frame: Baseline, 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.

  2. Change in blood biomarker

    Time frame: Baseline, Postseason (approximately 6 months)

    Neurofilament light chain (NfL) blood serum levels.

Secondary outcomes

  1. Change in King-Devick Test (KDT) scores

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • HealthTech Connex Inc.
  • Thorne HealthTech, Inc

Registry information

Official study title

The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2021
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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