Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

  • STATUS
    Recruiting
  • End date
    May 5, 2023
  • participants needed
    24
  • sponsor
    Natural Immune Systems Inc
Updated on 17 June 2022
Accepts healthy volunteers

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.

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.

Details
Condition Pharmacokinetics
Treatment Placebo, Ergothioneine, 25 miligrams, Ergothioneine, 25 miligrams, daily for 1 week
Clinical Study IdentifierNCT05042674
SponsorNatural Immune Systems Inc
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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