The Effect of Synaquell™ in Contact Sport Athletes

Mayo Clinic40 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Synaquell(TM)DIETARY_SUPPLEMENT

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).

PlaceboDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Houston Hawkins

CONTACT

507-293-3295 Hawkins.houston@mayo.edu

Data from ClinicalTrials.gov

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

Secondary Outcomes

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.

Time frame: Baseline, postseason (approximately 6 months).

Impact Monitor Mouthguard Acceleration

The Impact monitor mouthguard measures head acceleration.

Time frame: Beginning of practice to last game (approximately 6 months).

Impact Monitor Mouthguard Rotation

The Impact monitor mouthguard measures rotation of the head.

Time frame: Beginning of practice to last game (approximately 6 months).

Impact Monitor Mouthguard Head Impacts

The Impact monitor mouthguard measures the number of head impacts.

Time frame: Beginning of practice to last game (approximately 6 months).