The Effects of Synaquell on Brain Function

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

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Synaquell
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synaquell Group<br>Subjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season. | Dietary Supplement: Synaquell<br>* 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).<br>|
| Placebo Comparator: Placebo Group<br>Subjects will receive the placebo twice-daily, during the hockey season. | Dietary Supplement: Placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Change in blood biomarker | Neurofilament light chain (NfL) blood serum levels. | Baseline, Postseason (approximately 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ice Hockey, Cognitive Function, Cognition, Brain, Supplement, Contact Sport Athletes