The Effect of Synaquell™ in Contact Sport Athletes

Healthy Clinical Trial

Official title:

The Effect of Synaquell™ on Objective Measures of Brain Health in Male and Female Youth Contact Sport Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104670
• Other study ID #: 23-005242
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: Houston Hawkins
• Phone: 507-293-3295
• Email: Hawkins.houston[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• Fluent English Speakers

• Medically cleared to play contact sport

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Synaquell(TM)
7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).
• Placebo
7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in N100 Amplitude	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.	Baseline, Postseason (approximately 6 months).
Primary	Change in N100 Latency	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.	Baseline, Postseason (approximately 6 months).
Primary	Change in P300 Amplitude	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.	Baseline, Postseason (approximately 6 months).
Primary	Change in P300 Latency	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.	Baseline, Postseason (approximately 6 months).
Primary	Change in N400 Amplitude	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.	Baseline, Postseason (approximately 6 months).
Primary	Change in N400 Latency	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.	Baseline, Postseason (approximately 6 months).
Primary	Change in blood biomarker: NfL	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).	Baseline, postseason (approximately 6 months).
Primary	Change in blood biomarker SNCB.	Blood will be at a biomarker level and B-Synuclein will be investigated. The biomarker will be measured in Nanograms per Milliliter (ng/ml).	Baseline, postseason (approximately 6 months).
Primary	Change in blood biomarker vWF.	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).	Baseline, postseason (approximately 6 months).
Primary	Change in blood biomarker SNCA.	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).	Baseline, postseason (approximately 6 months).
Primary	Change in blood biomarker BDNF.	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).	Baseline, postseason (approximately 6 months).
Secondary	Change in King-Devick Test (KDT) scored	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.	Baseline, postseason (approximately 6 months).
Secondary	Impact Monitor Mouthguard Acceleration	The Impact monitor mouthguard measures head acceleration.	Beginning of practice to last game (approximately 6 months).
Secondary	Impact Monitor Mouthguard Rotation	The Impact monitor mouthguard measures rotation of the head.	Beginning of practice to last game (approximately 6 months).
Secondary	Impact Monitor Mouthguard Head Impacts	The Impact monitor mouthguard measures the number of head impacts.	Beginning of practice to last game (approximately 6 months).

External Links

•   Mayo Clinic Clinical Trials