NCT04556032

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 4, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 9, 2020

Last Update Submit

November 2, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery

    Baseline to Week 16

Secondary Outcomes (4)

  • Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery

    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

    Baseline to weeks 4, 8 and 16

  • Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)

    Baseline to weeks 4, 8 and 16

  • Changes in mood based on Profile of Mood States Questionnaire (POMS)

    Baseline to weeks 4, 8 and 16

Study Arms (3)

L-Ergothioneine 10 mg/d

EXPERIMENTAL

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

Dietary Supplement: L-Ergothioneine 10 mg/d

L-Ergothioneine 25 mg/d

EXPERIMENTAL

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

Dietary Supplement: L-Ergothioneine 25 mg/d

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally once daily for 16 weeks.

Other: Placebo

Interventions

L-Ergothioneine 10 mg/dDIETARY_SUPPLEMENT

L-Ergothioneine 10 mg/d

L-Ergothioneine 10 mg/d
L-Ergothioneine 25 mg/dDIETARY_SUPPLEMENT

L-Ergothioneine 25 mg/d

L-Ergothioneine 25 mg/d
PlaceboOTHER

0 mg/d L-Ergothioneine

Placebo

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 21, 2020

Study Start

September 9, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

November 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)