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Completed

NCT Number: NCT06104670

The Effect of Synaquell™ in Contact Sport Athletes

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

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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 & saliva biomarkers, impact monitoring mouthguard, 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 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

Treatment and study plan

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).

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: NfL

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

    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).

  8. Change in blood biomarker SNCB.

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

    Blood will be at a biomarker level and B-Synuclein will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml).

  9. Change in blood biomarker vWF.

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

    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).

  10. Change in blood biomarker SNCA.

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

    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).

  11. Change in blood biomarker BDNF.

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

    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).

Secondary outcomes

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

    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.

  2. Impact Monitor Mouthguard Acceleration

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

    The Impact monitor mouthguard measures head acceleration.

  3. Impact Monitor Mouthguard Rotation

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

    The Impact monitor mouthguard measures rotation of the head.

  4. Impact Monitor Mouthguard Head Impacts

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

    The Impact monitor mouthguard measures the number of head impacts.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Sanford Health

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2023
Registry last updated
Jun 25, 2026

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.

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