The Effect of Synaquell™ on Objective Measures of Brain Health in Male and Female Youth Contact Sport Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in P300 Amplitude
研究概览
简要总结
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.
详细描述
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).
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)
盲法说明
The study staff responsible for distributing SynaquellTM will not be blinded to the intervention, but all subjects and other study staff will be blinded.
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent English Speakers
- •Medically cleared to play contact sport
排除标准
- •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
研究组 & 干预措施
Experimental: Synaquell Male Group
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.
干预措施: Synaquell(TM) (Dietary Supplement)
Placebo Comparator: Placebo Male Group
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.
干预措施: Placebo (Dietary Supplement)
Experimental: Synaquell Female Group
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.
干预措施: Synaquell(TM) (Dietary Supplement)
Placebo Comparator: Placebo Female Group
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.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in P300 Amplitude
时间窗: Baseline, Postseason (approximately 6 months).
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.
Change in N400 Latency
时间窗: Baseline, Postseason (approximately 6 months).
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.
Change in N100 Latency
时间窗: Baseline, Postseason (approximately 6 months).
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.
Change in N400 Amplitude
时间窗: Baseline, Postseason (approximately 6 months).
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.
Change in N100 Amplitude
时间窗: Baseline, Postseason (approximately 6 months).
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.
Change in P300 Latency
时间窗: Baseline, Postseason (approximately 6 months).
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.
Change in blood biomarker SNCB.
时间窗: Baseline, postseason (approximately 6 months).
Blood will be at a biomarker level and B-Synuclein will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml).
Change in blood biomarker BDNF.
时间窗: Baseline, postseason (approximately 6 months).
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).
Change in blood biomarker: NfL
时间窗: Baseline, postseason (approximately 6 months).
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).
Change in blood biomarker vWF.
时间窗: Baseline, postseason (approximately 6 months).
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).
Change in blood biomarker SNCA.
时间窗: Baseline, postseason (approximately 6 months).
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).
次要结局
- Impact Monitor Mouthguard Acceleration(Beginning of practice to last game (approximately 6 months).)
- Change in King-Devick Test (KDT) scored(Baseline, postseason (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).)