The Effects of Synaquell on Brain Function of Ice Hockey Players

NCT05498818 | Completed

• 1 other identifier: 22-003414
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Ice Hockey; Cognitive Function; Cognition; Brain; Supplement; Contact Sport Athletes

Outcome Measures

Primary Outcomes (7)

• 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

  Neurofilament light chain (NfL) blood serum levels

  Baseline, Postseason (approximately 6 months)

Secondary Outcomes (1)

• Change in King-Devick Test (KDT) scores

  Baseline, Postseason (approximately 6 months)

Study Arms (4)

Synaquell Male Group

EXPERIMENTAL

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

Placebo Male Group

PLACEBO COMPARATOR

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

Synaquell Female Group

EXPERIMENTAL

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

Placebo Female Group

PLACEBO COMPARATOR

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

Interventions

Synaquell 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).

Synaquell Female Group; Synaquell Male Group

Placebo DIETARY_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.

Placebo Female Group; Placebo Male Group

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fluent English speakers
• Medically cleared to play ice hockey

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Michael Stuart, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study staff responsible for preparing and distributing SynaquellTM will not be blinded to the intervention, but all subjects and other study staff will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 12, 2022
• Study Start: November 3, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)