The Effects of Synaquell on Brain Function

Mayo Clinic54 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

SynaquellDIETARY_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).

PlaceboDIETARY_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).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in brain vital signs

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.

Time frame: Baseline, Postseason (approximately 6 months)

Change in blood biomarker

Neurofilament light chain (NfL) blood serum levels.

Time frame: Baseline, Postseason (approximately 6 months)

Secondary Outcomes

Change in King-Devick Test (KDT) scores

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.

Time frame: Baseline, Postseason (approximately 6 months)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.