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Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.
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| Name | Class |
|---|---|
| Blue California | INDUSTRY |
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The objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women.
This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of one screening (visit 1a, week 0), one baseline visit (visit 1b, week 0), and three treatment visits (visits 2, 3, and 4; weeks 4, 8, and 16).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Ergothioneine 10 mg/d | Experimental | Participants will receive L-Ergothioneine 10 mg capsule orally once daily for 16 weeks. |
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| L-Ergothioneine 25 mg/d | Experimental | Participants will receive L-Ergothioneine 25 mg capsule orally once daily for 16 weeks. |
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| Placebo | Placebo Comparator | Participants will receive placebo orally once daily for 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Ergothioneine 10 mg/d | Dietary Supplement | L-Ergothioneine 10 mg/d |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery | Baseline to weeks 4 and 8 | |
| Changes in standard scores for domains relating to memory, attention, and executive function from the Central Nervous System Vital Signs (CNS-VS) Test Battery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
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| L-Ergothioneine 25 mg/d |
| Dietary Supplement |
L-Ergothioneine 25 mg/d |
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| Placebo | Other | 0 mg/d L-Ergothioneine |
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| Baseline to weeks 4, 8 and 16 |
| Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ) | Baseline to weeks 4, 8 and 16 |
| Changes in mood based on Profile of Mood States Questionnaire (POMS) | Baseline to weeks 4, 8 and 16 |