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

November 2, 2020 updated by: Midwest Center for Metabolic and Cardiovascular Research

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 75 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline to Week 16
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
Time Frame: Baseline to weeks 4 and 8
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
Time Frame: Baseline to weeks 4, 8 and 16
Baseline to weeks 4, 8 and 16
Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: Baseline to weeks 4, 8 and 16
Baseline to weeks 4, 8 and 16
Changes in mood based on Profile of Mood States Questionnaire (POMS)
Time Frame: Baseline to weeks 4, 8 and 16
Baseline to weeks 4, 8 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Center for Metabolic and Cardiovascular Research

Collaborators

Blue California Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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