The Effect of Synaquell™ in Contact Sport Athletes

Study Overview
=================
Brief Summary
-----------------
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.

Detailed Description
-----------------
This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood & saliva biomarkers, impact monitoring mouthguard, and a rapid number naming test (King Devick).

Official Title
-----------------
The Effect of Synaquell™ on Objective Measures of Brain Health in Male and Female Youth Contact Sport Athletes

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Synaquell(TM)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent English Speakers Medically cleared to play contact sport Exclusion Criteria: An allergy to the ingredients of Synaquell™ or the placebo (ingredients listed on page 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 Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Synaquell Male Group<br>Male youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. | Dietary Supplement: Synaquell(TM)<br>* 7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).<br>|
| Placebo Comparator: Placebo Comparator: Placebo Male Group<br>Male youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. | Dietary Supplement: Placebo<br>* 7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.<br>|
| Experimental: Experimental: Synaquell Female Group<br>Female youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. | Dietary Supplement: Synaquell(TM)<br>* 7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).<br>|
| Placebo Comparator: Placebo Comparator: Placebo Female Group<br>Female youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. | Dietary Supplement: Placebo<br>* 7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in N100 Amplitude | Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation. | Baseline, Postseason (approximately 6 months). | 
| Change in N100 Latency | Obtained by EEG recording of N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation. | Baseline, Postseason (approximately 6 months). | 
| Change in P300 Amplitude | Obtained by EEG recording of P300 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation. | Baseline, Postseason (approximately 6 months). | 
| Change in P300 Latency | Obtained by EEG recording of P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation. | Baseline, Postseason (approximately 6 months). | 
| Change in N400 Amplitude | Obtained by EEG recording of N400 potential amplitude. Increased amplitudes are indicative of larger signals.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation. | Baseline, Postseason (approximately 6 months). | 
| Change in N400 Latency | Obtained by EEG recording of N400 potential latency. Increased latencies are indicative of slower responses.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation. | Baseline, Postseason (approximately 6 months). | 
| Change in blood biomarker: NfL | Blood will be at a biomarker level. We will investigate the biomarker neurofilament light (NfL). BDNF. The biomarker will be measured in Nanograms per Milliliter (ng/ml). | Baseline, postseason (approximately 6 months). | 
| Change in blood biomarker SNCB. | Blood will be at a biomarker level and B-Synuclein will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml). | Baseline, postseason (approximately 6 months). | 
| Change in blood biomarker vWF. | Blood will be at a biomarker level and Von Willebrand Factor (vWF) will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml). | Baseline, postseason (approximately 6 months). | 
| Change in blood biomarker SNCA. | Blood will be at a biomarker level and A-Synuclein (SNCA) will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml). | Baseline, postseason (approximately 6 months). | 
| Change in blood biomarker BDNF. | Blood will be at a biomarker level and Brain Derived Neurotrophic Factor (BDNF) will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml). | Baseline, postseason (approximately 6 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in King-Devick Test (KDT) scored | A rapid number-naming test that requires individuals to read 3 numbered patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant. | Baseline, postseason (approximately 6 months). | 
| Impact Monitor Mouthguard Acceleration | The Impact monitor mouthguard measures head acceleration. | Beginning of practice to last game (approximately 6 months). | 
| Impact Monitor Mouthguard Rotation | The Impact monitor mouthguard measures rotation of the head. | Beginning of practice to last game (approximately 6 months). | 
| Impact Monitor Mouthguard Head Impacts | The Impact monitor mouthguard measures the number of head impacts. | Beginning of practice to last game (approximately 6 months). | 

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