NCT05042674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

September 4, 2021

Last Update Submit

June 7, 2022

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Change in level of reduced glutathione

    Mean fluorescence

    2 hours

Secondary Outcomes (1)

  • Change in mitochondrial mass and mitochondrial potential from baseline

    2 hours

Other Outcomes (2)

  • Change in level of reduced glutathione

    1 week

  • Change in mitochondrial mass and mitochondrial potential from baseline

    1 week

Study Arms (1)

Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily

OTHER

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: PlaceboDietary Supplement: Ergothioneine, 25 miligramsDietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily
Ergothioneine, 25 miligramsDIETARY_SUPPLEMENT

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

Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily
Ergothioneine, 25 miligrams, daily for 1 weekDIETARY_SUPPLEMENT

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

Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

MeSH Terms

Interventions

Ergothioneine

Intervention Hierarchy (Ancestors)

Sulfhydryl CompoundsSulfur CompoundsOrganic ChemicalsHistidineAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Gitte Jensen, PhD

    NIS Labs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte Jensen, PhD

CONTACT

541-884-0112gitte@nislabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

September 4, 2021

First Posted

September 13, 2021

Study Start

September 20, 2021

Primary Completion

March 25, 2023

Study Completion

May 5, 2023

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)