Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
NCT ID: NCT05042674
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-09-20
2023-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily
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
after a blood draw placebo will be consumed followed by 2 additional blood draws
Ergothioneine, 25 miligrams
after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws
Ergothioneine, 25 miligrams, daily for 1 week
a blood draw will be administered after a week of consuming 25mg ergothioneine daily
Interventions
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Placebo
after a blood draw placebo will be consumed followed by 2 additional blood draws
Ergothioneine, 25 miligrams
after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws
Ergothioneine, 25 miligrams, daily for 1 week
a blood draw will be administered after a week of consuming 25mg ergothioneine daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Natural Immune Systems Inc
OTHER
Responsible Party
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Gitte Jensen, Ph.D.
Research Director
Principal Investigators
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Gitte Jensen, PhD
Role: PRINCIPAL_INVESTIGATOR
NIS Labs
Locations
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NIS Labs
Klamath Falls, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIS174-003
Identifier Type: -
Identifier Source: org_study_id
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