Pharmacokinetics
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
after a blood draw placebo will be consumed followed by 2 additional blood draws
DIETARY_SUPPLEMENTErgothioneine, 25 miligrams
after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws
DIETARY_SUPPLEMENTErgothioneine, 25 miligrams, daily for 1 week
a blood draw will be administered after a week of consuming 25mg ergothioneine daily
Sponsors
Natural Immune Systems Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in level of reduced glutathione | 2 hours | Mean fluorescence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mitochondrial mass and mitochondrial potential from baseline | 2 hours | Mean fluorescence |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in mitochondrial mass and mitochondrial potential from baseline | 1 week | Mean fluorescence |
| Change in level of reduced glutathione | 1 week | Mean fluorescence |
Countries
United States
Contacts
Primary ContactGitte Jensen, PhD
Outcome results
None listed