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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04556032
• Other study ID #: MB-2011
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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