The Effects of Synaquell on Brain Function of Ice Hockey Players

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Synaquell; Dietary Supplement: Placebo

• Registration Number: NCT05498818
• Lead Sponsor: Mayo Clinic

Brief Summary

This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.

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 biomarkers and a rapid number naming test (King Devick).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Study Start: 2022-11-03
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Fluent English speakers
• Medically cleared to play ice hockey

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Exclusion Criteria

• An allergy to the ingredients of SynaquellTM or the placebo
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synaquell Male Group	Synaquell	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.
Placebo Male Group	Placebo	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.
Synaquell Female Group	Synaquell	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.
Placebo Female Group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in N100 Amplitude	Baseline, Postseason (approximately 6 months)	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.
Change in P300 Amplitude	Baseline, Postseason (approximately 6 months)	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.
Change in P300 Latency	Baseline, Postseason (approximately 6 months)	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.
Change in N400 Amplitude	Baseline, Postseason (approximately 6 months)	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.
Change in blood biomarker	Baseline, Postseason (approximately 6 months)	Neurofilament light chain (NfL) blood serum levels
Change in N400 Latency	Baseline, Postseason (approximately 6 months)	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.
Change in N100 Latency	Baseline, Postseason (approximately 6 months)	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.

Secondary Outcome Measures

Name	Time	Method
Change in King-Devick Test (KDT) scores	Baseline, Postseason (approximately 6 months)	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States