Recruiting

Antioxidant Protection

Sponsor:

Natural Immune Systems Inc

Code:

NCT05042674

Conditions

Pharmacokinetics

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Placebo

Ergothioneine, 25 miligrams

Ergothioneine, 25 miligrams, daily for 1 week

Study Details

Brief 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.

Conditions

Pharmacokinetics

Study ID

NCT05042674

Start date

Sep 20, 2021

Status verified date

Jun, 2022

Completion date

May 5, 2023

Anticipated

Primary completion date

Mar 25, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: 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

Interventions

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

Primary outcome measure

  • Change in level of reduced glutathione [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Gitte Jensen, PhD

541-884-0112gitte@nislabs.com

Locations

NIS Labs

Recruiting

Klamath Falls, Oregon, United States, 97601

Contacts

Gitte Jensen, PhD

541-884-0112gitte@nislabs.com

Principal Investigator:

Gitte S Jensen, PhD

More Information

Sponsor

Natural Immune Systems Inc

Last update posted

Jun 9, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natural Immune Systems Inc on 2022-06-09.