The Effect of Synaquell™ in Contact Sport Athletes

NCT06104670 | Recruiting

• 1 other identifier: 23-005242
• Study Type: interventional
• Target: 40
• 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 contact sport athletes.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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: NfL

  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).

  Baseline, postseason (approximately 6 months).

• Change in blood biomarker SNCB.

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

  Baseline, postseason (approximately 6 months).

• Change in blood biomarker vWF.

  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).

  Baseline, postseason (approximately 6 months).

• Change in blood biomarker SNCA.

  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).

  Baseline, postseason (approximately 6 months).

• Change in blood biomarker BDNF.

  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).

  Baseline, postseason (approximately 6 months).

Secondary Outcomes (4)

• Change in King-Devick Test (KDT) scored

  Baseline, postseason (approximately 6 months).

• Impact Monitor Mouthguard Acceleration

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

• Impact Monitor Mouthguard Rotation

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

• Impact Monitor Mouthguard Head Impacts

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

Study Arms (4)

Experimental: 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(TM)

Placebo Comparator: 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

Experimental: 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(TM)

Placebo Comparator: 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(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).

Experimental: Synaquell Female Group; Experimental: 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 Comparator: Placebo Female Group; Placebo Comparator: 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 contact sport

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Sanford Health: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Mario Hevesi, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Houston Hawkins

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study staff responsible for 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: October 20, 2023
• First Posted: October 27, 2023
• Study Start: November 2, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)