Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

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.

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Ergothioneine, 25 miligrams; Dietary supplement: Ergothioneine, 25 miligrams, daily for 1 week

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gitte Jensen, PhD; Phone Number: 541-884-0112; Email: gitte@nislabs.com

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • NIS Labs
      • Contact: Gitte Jensen, PhD; Phone Number: 541-884-0112; Email: gitte@nislabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of reduced glutathione	Mean fluorescence	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mitochondrial mass and mitochondrial potential from baseline	Mean fluorescence	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of reduced glutathione	Mean fluorescence	1 week
Change in mitochondrial mass and mitochondrial potential from baseline	Mean fluorescence	1 week

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Investigators: Principal Investigator: Gitte Jensen, PhD, NIS Labs

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Anticipated): March 25, 2023
• Study Completion (Anticipated): May 5, 2023

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: September 4, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Ergothioneine
• Other Study ID Numbers: NIS174-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No