Clinical trial NCT04556032: Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
Official title: A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Midwest Center for Metabolic and Cardiovascular Research
Sponsor class: OTHER
Collaborators: name: Blue California Company
First posted: 2020-09-21
Enrollment: 4
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
timeFrame: Baseline to weeks 4 and 8
measure: Changes in standard scores for domains relating to memory, attention, and executive function from the Central Nervous System Vital Signs (CNS-VS) Test Battery
timeFrame: Baseline to weeks 4, 8 and 16
measure: Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: Baseline to weeks 4, 8 and 16
measure: Changes in mood based on Profile of Mood States Questionnaire (POMS)
timeFrame: Baseline to weeks 4, 8 and 16
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
Study officials:
References: