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

Midwest Center for Metabolic and Cardiovascular Research

Status: Terminated

Conditions: Healthy

Treatments: Other: Placebo; Dietary Supplement: L-Ergothioneine 10 mg/d; Dietary Supplement: L-Ergothioneine 25 mg/d

Study type: Interventional

Funder types: Other

Identifiers

NCT04556032

MB-2011

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

4 participants in 3 patient groups, including a placebo group

L-Ergothioneine 10 mg/d

Experimental group

Description:

Participants will receive L-Ergothioneine 10 mg capsule orally once daily for 16 weeks.

Treatment:

Dietary Supplement: L-Ergothioneine 10 mg/d

L-Ergothioneine 25 mg/d

Experimental group

Description:

Participants will receive L-Ergothioneine 25 mg capsule orally once daily for 16 weeks.

Treatment:

Dietary Supplement: L-Ergothioneine 25 mg/d

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally once daily for 16 weeks.

Treatment:

Other: Placebo