Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Study Overview
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Brief Summary
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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
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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 Title
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Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Ergothioneine, 25 miligrams
* Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily<br>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 | Dietary Supplement: Placebo<br>* after a blood draw placebo will be consumed followed by 2 additional blood draws<br>Dietary Supplement: Ergothioneine, 25 miligrams<br>* after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws<br>Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week<br>* a blood draw will be administered after a week of consuming 25mg ergothioneine daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of reduced glutathione | Mean fluorescence | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mitochondrial mass and mitochondrial potential from baseline | Mean fluorescence | 2 hours |