Clinical trial NCT06104670: The Effect of Synaquell™ in Contact Sport Athletes
Official title: The Effect of Synaquell™ on Objective Measures of Brain Health in Male and Female Youth Contact Sport Athletes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Ice Hockey
Cognitive Function
Cognition Brain Supplement
Contact Sport Athletes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Sanford Health
First posted: 2023-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 \& saliva biomarkers, impact monitoring mouthguard, and a rapid number naming test (King Devick).

Eligibility criteria: 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

Primary outcomes:
measure: Change in N100 Amplitude
timeFrame: Baseline, Postseason (approximately 6 months).
measure: Change in N100 Latency
timeFrame: Baseline, Postseason (approximately 6 months).
measure: Change in P300 Amplitude
timeFrame: Baseline, Postseason (approximately 6 months).
measure: Change in P300 Latency
timeFrame: Baseline, Postseason (approximately 6 months).
measure: Change in N400 Amplitude
timeFrame: Baseline, Postseason (approximately 6 months).
measure: Change in N400 Latency
timeFrame: Baseline, Postseason (approximately 6 months).
measure: Change in blood biomarker: NfL
timeFrame: Baseline, postseason (approximately 6 months).
measure: Change in blood biomarker SNCB.
timeFrame: Baseline, postseason (approximately 6 months).
measure: Change in blood biomarker vWF.
timeFrame: Baseline, postseason (approximately 6 months).
measure: Change in blood biomarker SNCA.
timeFrame: Baseline, postseason (approximately 6 months).
measure: Change in blood biomarker BDNF.
timeFrame: Baseline, postseason (approximately 6 months).
Secondary outcomes:
measure: Change in King-Devick Test (KDT) scored
timeFrame: Baseline, postseason (approximately 6 months).
measure: Impact Monitor Mouthguard Acceleration
timeFrame: Beginning of practice to last game (approximately 6 months).
measure: Impact Monitor Mouthguard Rotation
timeFrame: Beginning of practice to last game (approximately 6 months).
measure: Impact Monitor Mouthguard Head Impacts
timeFrame: Beginning of practice to last game (approximately 6 months).
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mario Hevesi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: