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

NCT ID: NCT04556032

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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L-Ergothioneine 10 mg/d

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

Group Type EXPERIMENTAL

L-Ergothioneine 10 mg/d

Intervention Type DIETARY_SUPPLEMENT

L-Ergothioneine 10 mg/d

L-Ergothioneine 25 mg/d

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

Group Type EXPERIMENTAL

L-Ergothioneine 25 mg/d

Intervention Type DIETARY_SUPPLEMENT

L-Ergothioneine 25 mg/d

Placebo

Participants will receive placebo orally once daily for 16 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0 mg/d L-Ergothioneine

Interventions

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L-Ergothioneine 10 mg/d

L-Ergothioneine 10 mg/d

Intervention Type DIETARY_SUPPLEMENT

L-Ergothioneine 25 mg/d

L-Ergothioneine 25 mg/d

Intervention Type DIETARY_SUPPLEMENT

Placebo

0 mg/d L-Ergothioneine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blue California Company

UNKNOWN

Sponsor Role collaborator

Midwest Center for Metabolic and Cardiovascular Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Great Lakes Clinical Trials

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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MB-2011

Identifier Type: -

Identifier Source: org_study_id