Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: L-Ergothioneine 10 mg/d
* Dietary Supplement: L-Ergothioneine 25 mg/d
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 55-79 years of age. Body mass index (BMI) 18.50-34.99 kg/m2 Non-smoker defined as no smoking for at least 6 months. Willing to limit alcohol and caffeine consumption Generally, in good health based on medical history and laboratory assessments Agree to avoid consumption of mushrooms and excluded medications/supplements for the duration of the study Willing to commit to all study procedures Exclusion Criteria: Consumption of mushrooms more than once per week History or presence of a psychiatric or neurologic disease including, but not limited to, epilepsy, cerebrovascular disturbance, traumatic injury, or clinically diagnosed dementia or Alzheimer's disease. Scores ≥17 on the Beck Depression Inventory History of cardiovascular complications, type 1 or type 2 diabetes mellitus, uncontrolled hypertension, or any other clinically significant disorder History of cancer except non-melanoma skin cancer or carcinoma in situ of the cervix within the past 2 years Use of any product containing marijuana (THC) and/or cannabidiol (CBD) including oral consumption, inhalation, & other Any intolerance to any components of the study products Exposure to any non-registered drug product within the past 30 days History of drug or alcohol abuse Considered unfit for any reason as determined by the principal investigator

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-Ergothioneine 10 mg/d<br>Participants will receive L-Ergothioneine 10 mg capsule orally once daily for 16 weeks. | Dietary Supplement: L-Ergothioneine 10 mg/d<br>* L-Ergothioneine 10 mg/d<br>|
| Experimental: L-Ergothioneine 25 mg/d<br>Participants will receive L-Ergothioneine 25 mg capsule orally once daily for 16 weeks. | Dietary Supplement: L-Ergothioneine 25 mg/d<br>* L-Ergothioneine 25 mg/d<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo orally once daily for 16 weeks. | Other: Placebo<br>* 0 mg/d L-Ergothioneine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |