Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Pharmacokinetics Clinical Trial

Official title:

Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042674
• Other study ID #: NIS174-003
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: May 5, 2023

Study information

• Verified date: June 2022
• Source: Natural Immune Systems Inc
• Contact: Gitte Jensen, PhD
• Phone: 541-884-0112
• Email: gitte[@]nislabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 5, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	NIS Labs	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in level of reduced glutathione	Mean fluorescence	1 week
Other	Change in mitochondrial mass and mitochondrial potential from baseline	Mean fluorescence	1 week
Primary	Change in level of reduced glutathione	Mean fluorescence	2 hours
Secondary	Change in mitochondrial mass and mitochondrial potential from baseline	Mean fluorescence	2 hours