The Effects of Synaquell on Brain Function
- Conditions
- Healthy
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Synaquell
- Registration Number
- NCT05041192
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
- Detailed Description
Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
- 18 years of age or greater.
- Fluent English speakers.
- Medically cleared to play ice hockey.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo Subjects will receive the placebo twice-daily, during the hockey season. Synaquell Group Synaquell Subjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season.
- Primary Outcome Measures
Name Time Method Change in brain vital signs Baseline, Postseason (approximately 6 months) 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.
Change in blood biomarker Baseline, Postseason (approximately 6 months) Neurofilament light chain (NfL) blood serum levels.
- Secondary Outcome Measures
Name Time Method Change in King-Devick Test (KDT) scores Baseline, Postseason (approximately 6 months) A rapid number-naming test that requires individuals to read 3 numbered cards a loud as fast as possible, the resulting time is the KDT score.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States