The Effects of Synaquell on Brain Function

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041192
• Other study ID #: 21-004746
• Status: Completed
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: November 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Synaquell
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
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).

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	HealthTech Connex Inc., Thorne Research Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Postseason (approximately 6 months)
Primary	Change in blood biomarker	Neurofilament light chain (NfL) blood serum levels.	Baseline, Postseason (approximately 6 months)
Secondary	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.	Baseline, Postseason (approximately 6 months)

External Links

•   Mayo Clinic Clinical Trials