Healthy
Conditions
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTL-Ergothioneine 10 mg/d
L-Ergothioneine 10 mg/d
DIETARY_SUPPLEMENTL-Ergothioneine 25 mg/d
L-Ergothioneine 25 mg/d
OTHERPlacebo
0 mg/d L-Ergothioneine
Sponsors
Blue California Company
Midwest Center for Metabolic and Cardiovascular Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed