The Effect of Synaquell™ in Contact Sport Athletes
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Synaquell(TM)Dietary Supplement: Placebo
- Registration Number
- NCT06104670
- Lead Sponsor
- Mayo Clinic
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Fluent English Speakers
- Medically cleared to play contact sport
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Synaquell Male Group Synaquell(TM) 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. Experimental: Synaquell Female Group Synaquell(TM) 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. Placebo Comparator: Placebo Male Group Placebo 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. Placebo Comparator: Placebo Female Group Placebo 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.
- Primary Outcome Measures
Name Time Method Change in P300 Amplitude 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 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 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 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 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 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. 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. 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 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. 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. 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).
- Secondary Outcome Measures
Name Time Method Impact Monitor Mouthguard Acceleration Beginning of practice to last game (approximately 6 months). The Impact monitor mouthguard measures head acceleration.
Change in King-Devick Test (KDT) scored Baseline, postseason (approximately 6 months). A rapid number-naming test that requires individuals to read 3 numbered patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant.
Impact Monitor Mouthguard Rotation Beginning of practice to last game (approximately 6 months). The Impact monitor mouthguard measures rotation of the head.
Impact Monitor Mouthguard Head Impacts Beginning of practice to last game (approximately 6 months). The Impact monitor mouthguard measures the number of head impacts.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States