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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: L-Ergothioneine 10 mg/d; Dietary supplement: L-Ergothioneine 25 mg/d; Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborators: Blue California Company

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Ergothioneine
• Other Study ID Numbers: MB-2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No