Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

NCT05042674 — Not applicable, Unknown, 24 participants, Natural Immune Systems Inc

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RegistryNCT05042674
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, basic science
Enrollment24 (Estimated)
SponsorNatural Immune Systems Inc (Other)
ConditionsPharmacokinetics
InterventionsPlacebo, Ergothioneine, 25 miligrams, Ergothioneine, 25 miligrams, daily for 1 week (Dietary supplement)
Datesstart 2021-09-20, primary completion 2023-03-25 (estimated), completion 2023-05-05 (estimated), first posted 2021-09-13, last updated 2022-06-09
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Pharmacokinetics All trials of Placebo All trials of Ergothioneine, 25 miligrams

-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.

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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week dailyOtherDietary Supplement: Placebo; Dietary Supplement: Ergothioneine, 25 miligrams; Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 weekParticipants 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 (Dietary supplement): after a blood draw placebo will be consumed followed by 2 additional blood draws
  • Ergothioneine, 25 miligrams (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 (Dietary supplement): a blood draw will be administered after a week of consuming 25mg ergothioneine daily

+Outcome measures

Primary outcomes

  • Change in level of reduced glutathione [2 hours]: Mean fluorescence

Secondary outcomes

  • Change in mitochondrial mass and mitochondrial potential from baseline [2 hours]: Mean fluorescence

Other outcomes

  • Change in level of reduced glutathione [1 week]: Mean fluorescence
  • Change in mitochondrial mass and mitochondrial potential from baseline [1 week]: Mean fluorescence

+Eligibility

Sex: All, ages: 18 Years to 75 Years, 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

+Locations (1)

FacilityCityCountryStatus
NIS LabsKlamath Falls, OregonUnited StatesRecruiting

+Investigators