Skip to main content
OpenTrials
Completed

NCT Number: NCT05498818

The Effects of Synaquell on Brain Function of Ice Hockey Players

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent English speakers
  • Medically cleared to play ice hockey

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Change in N100 Amplitude

    Time frame: 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.

  2. Change in N100 Latency

    Time frame: 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.

  3. Change in P300 Amplitude

    Time frame: 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.

  4. Change in P300 Latency

    Time frame: 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.

  5. Change in N400 Amplitude

    Time frame: 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.

  6. Change in N400 Latency

    Time frame: 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.

  7. Change in blood biomarker

    Time frame: Baseline, Postseason (approximately 6 months)

    Neurofilament light chain (NfL) blood serum levels

Secondary outcomes

  1. Change in King-Devick Test (KDT) scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.