| Registry | NCT05042674 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, basic science |
| Enrollment | 24 (Estimated) |
| Sponsor | Natural Immune Systems Inc (Other) |
| Conditions | Pharmacokinetics |
| Interventions | Placebo, Ergothioneine, 25 miligrams, Ergothioneine, 25 miligrams, daily for 1 week (Dietary supplement) |
| Dates | start 2021-09-20, primary completion 2023-03-25 (estimated), completion 2023-05-05 (estimated), first posted 2021-09-13, last updated 2022-06-09 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Pharmacokinetics All trials of Placebo All trials of Ergothioneine, 25 miligrams
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily | Other | Dietary Supplement: Placebo; Dietary Supplement: Ergothioneine, 25 miligrams; Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week | 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 |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| NIS Labs | Klamath Falls, Oregon | United States | Recruiting |