The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in brain vital signs
研究概览
简要总结
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 years of age or greater.
- •Fluent English speakers.
- •Medically cleared to play ice hockey.
排除标准
- •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.
结局指标
主要结局
Change in brain vital signs
时间窗: 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
时间窗: Baseline, Postseason (approximately 6 months)
Neurofilament light chain (NfL) blood serum levels.
次要结局
- Change in King-Devick Test (KDT) scores(Baseline, Postseason (approximately 6 months))
研究者
Michael J. Stuart
Principal Investigator
Mayo Clinic