Suspended
Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
What is being tested
Placebo
+ Ergothioneine, 25 miligrams
+ Ergothioneine, 25 miligrams, daily for 1 week
Dietary Supplement
Who is being recruted
From 18 to 75 Years
+19 Eligibility Criteria
How is the trial designed
Basic Science Study
Interventional
Study Start: September 2021
Summary
Principal SponsorNatural Immune Systems Inc
Study ContactGitte Jensen, PhD
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: September 20, 2021
Actual date on which the first participant was enrolled.A randomized, cross-over study design will be used to evaluate immune effects of consumption of 25 mg ergothioneine. On the first clinic day, participants will take a placebo with a one week wash out. Following the wash out week, participants will take 25 mg ergothioneine for 7 consecutive days.
Official TitleClinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
Principal SponsorNatural Immune Systems Inc
Study ContactGitte Jensen, PhD
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements
Willing to maintain a consistent diet and lifestyle routine throughout the study
Willing to avoid consumption of meals where the predominant ingredients include mushrooms, seafood, and organ meat (liver, heart).*
Willing to abstaining from exercising on the morning of a study visit
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13 exclusion criteria prevent from participating
Previous major gastrointestinal surgery
Active chronic immunological disease
Currently taking daily OTC medications, prescription pain medications, antipsychotic medications, anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects if the test product, nutritional supplements containing medicinal mushroom extracts
Diagnose with Type I diabetes, autoimmune disorders
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Participants will consume placebo on first study day, consume 25mg of ergothioneine on second study day, then consume 25mg of ergothioneine daily for 1 week
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center