Clinical trial NCT05042674: Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
Official title: Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in level of reduced glutathione
timeFrame: 2 hours
Secondary outcomes:
measure: Change in mitochondrial mass and mitochondrial potential from baseline
timeFrame: 2 hours
Other outcomes:
measure: Change in level of reduced glutathione
timeFrame: 1 week
measure: Change in mitochondrial mass and mitochondrial potential from baseline
timeFrame: 1 week
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: