Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Natural Immune Systems

Status: Enrolling

Conditions: Pharmacokinetics

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ergothioneine, 25 miligrams; Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week

Study type: Interventional

Funder types: Other

Identifiers

NCT05042674

NIS174-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily

Other group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week

Dietary Supplement: Ergothioneine, 25 miligrams