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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556032
Recruitment Status : Terminated (Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.)
First Posted : September 21, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Blue California Company
Information provided by (Responsible Party):
Midwest Center for Metabolic and Cardiovascular Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: L-Ergothioneine 10 mg/d Dietary Supplement: L-Ergothioneine 25 mg/d Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 9, 2020
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ) [ Time Frame: Baseline to weeks 4, 8 and 16 ]
  4. Changes in mood based on Profile of Mood States Questionnaire (POMS) [ Time Frame: Baseline to weeks 4, 8 and 16 ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556032


Locations
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United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
Sponsors and Collaborators
Midwest Center for Metabolic and Cardiovascular Research
Blue California Company
More Information
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Responsible Party: Midwest Center for Metabolic and Cardiovascular Research
ClinicalTrials.gov Identifier: NCT04556032    
Other Study ID Numbers: MB-2011
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ergothioneine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs