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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04556032
Other study ID # MB-2011
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 9, 2020
Est. completion date October 30, 2020

Study information

Verified date September 2020
Source Midwest Center for Metabolic and Cardiovascular Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 55 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Great Lakes Clinical Trials Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Midwest Center for Metabolic and Cardiovascular Research Blue California Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery Baseline to Week 16
Secondary Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery Baseline to weeks 4 and 8
Secondary 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
Secondary Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ) Baseline to weeks 4, 8 and 16
Secondary Changes in mood based on Profile of Mood States Questionnaire (POMS) Baseline to weeks 4, 8 and 16
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