Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT04556032
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
79 Years
Study:
NCT04556032
Study Brief:
Protocol Section:
NCT04556032