The Effects of Synaquell on Brain Function
The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players
1 other identifier
interventional
54
1 country
1
Brief Summary
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2021
CompletedStudy Start
First participant enrolled
September 3, 2021
CompletedFirst Posted
Study publicly available on registry
September 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedNovember 29, 2022
November 1, 2022
8 months
September 2, 2021
November 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in brain vital signs
Obtained by EEG recording of N100, P300, N400 amplitudes and latencies. Increased amplitudes are indicative of larger signals and increased latencies are indicative of slower responses.
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 (2)
Synaquell Group
EXPERIMENTALSubjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season.
Placebo Group
PLACEBO COMPARATORSubjects will receive the placebo twice-daily, during the hockey season.
Interventions
7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).
7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).
Eligibility Criteria
You may qualify if:
- years of age or greater.
- Fluent English speakers.
- Medically cleared to play ice hockey.
You may not qualify if:
- An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).
- 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.
- Unhealthy scalp.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- HealthTech Connex Inc.collaborator
- Thorne HealthTech, Inccollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Stuart, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2021
First Posted
September 10, 2021
Study Start
September 3, 2021
Primary Completion
April 22, 2022
Study Completion
April 22, 2022
Last Updated
November 29, 2022
Record last verified: 2022-11