Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Not Applicable

• Conditions: Pharmacokinetics
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Ergothioneine, 25 miligrams; Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week

• Registration Number: NCT05042674
• Lead Sponsor: Natural Immune Systems Inc

Brief Summary

A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-04
• Study First Posted: 2021-09-13
• Study Start: 2021-09-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09
• Primary Completion: 2023-03-25
• Study Completion: 2023-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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
• Willing to abstain from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit
• Willing to abstain from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria

• 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
• Getting regular joint injections
• Active severe chronic disease (such as HIV, chronic hepatitis)
• Currently experiencing intense stressful events/ life changes
• Currently in intensive athletic training
• Experiencing an unusual sleep routine
• Unwilling to maintain a constant intake of supplements over the duration of the study
• Anxiety about having blood drawn
• Women who are pregnant, nursing, or trying to become pregnant
• Known food allergies to ingredients in test product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily	Placebo	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
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily	Ergothioneine, 25 miligrams	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
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily	Ergothioneine, 25 miligrams, daily for 1 week	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

Primary Outcome Measures

Name	Time	Method
Change in level of reduced glutathione	2 hours	Mean fluorescence

Secondary Outcome Measures

Name	Time	Method
Change in mitochondrial mass and mitochondrial potential from baseline	2 hours	Mean fluorescence

Trial Locations

Locations (1)

NIS Labs; 🇺🇸 Klamath Falls, Oregon, United States