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| Name | Class |
|---|---|
| HealthTech Connex Inc. | INDUSTRY |
| Thorne HealthTech, Inc | INDUSTRY |
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The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synaquell Group | Experimental | Subjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season. |
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| Placebo Group | Placebo Comparator | Subjects will receive the placebo twice-daily, during the hockey season. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synaquell | Dietary Supplement | 7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in brain vital signs | 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. | Baseline, Postseason (approximately 6 months) |
| Change in blood biomarker | Neurofilament light chain (NfL) blood serum levels. | Baseline, Postseason (approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in King-Devick Test (KDT) scores | 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. | Baseline, Postseason (approximately 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Stuart, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Placebo | Dietary Supplement | 7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams). |
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