Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

NCT ID: NCT05042674

Last Updated: 2022-06-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-05-05

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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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

Group Type OTHER

Placebo

Intervention Type DIETARY_SUPPLEMENT

after a blood draw placebo will be consumed followed by 2 additional blood draws

Ergothioneine, 25 miligrams

Intervention Type DIETARY_SUPPLEMENT

after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws

Ergothioneine, 25 miligrams, daily for 1 week

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Ergothioneine, 25 miligrams

after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws

Intervention Type DIETARY_SUPPLEMENT

Ergothioneine, 25 miligrams, daily for 1 week

a blood draw will be administered after a week of consuming 25mg ergothioneine daily

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Immune Systems Inc

OTHER

Sponsor Role lead

Responsible Party

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Gitte Jensen, Ph.D.

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gitte Jensen, PhD

Role: CONTACT

541-884-0112

Facility Contacts

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Gitte Jensen, PhD

Role: primary

541-884-0112

Other Identifiers

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NIS174-003

Identifier Type: -

Identifier Source: org_study_id

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