Clinical Trial: Rapid Immune Modulating Effects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Agaricus blazei, Reishi, Turkey Tail, Placebo.
- Who it may be relevant to
- Registry conditions: Immune Surveillance. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Trail: Rapid Immune Modulating Effects
Overview
The goal for this clinical trial is to compare the immune effects of three different medicinal mushrooms to a placebo. The mushrooms include Agaricus, Reishi, and Turkey Tail.
Detailed description
The goal for this clinical trial is to compare acute immune effects of three different medicinal mushrooms to a placebo in a healthy population. The mushrooms include Agaricus, Reishi, and Turkey Tail.
The outcomes include immune cell communication via pro- and anti-inflammatory cytokines, increased immune cell alertness, and immune cell trafficking and surveillance.
These activities happen normally as part of our immune system's circadian cycles and can be significantly enhanced by consuming nutraceutical products.
Interventions
- Dietary supplement Agaricus blazei
Agaricus blazei mushroom capsules. 2000 mg per serving - Dietary supplement Reishi
Reishi mushroom capsules. 2000 mg per serving. - Dietary supplement Turkey Tail
Turkey tail mushroom capsules. 2000 mg per serving. - Other Placebo
Placebo
Primary outcome measures
- Immune Communication [Time frame: 2 hours after consuming a test product for this study protocol]
Secondary outcome measures (1)
- Immune Cell Surveillance [Time frame: 2 hours after consuming a test product for this study protocol]
Eligibility criteria
Inclusion criteria
- Healthy adults;
- Age 18-75 years (inclusive);
- Veins easy to see in one or both arms (to allow for the multiple blood draws);
- Willing to comply with study procedures, including:
- Maintaining a consistent diet and lifestyle routine throughout the study,
- Consistent habit of bland breakfasts on days of clinic visits,
- Abstaining from exercising and nutritional supplements on the morn ing of a study visit,
- Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
- Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.
Exclusion criteria
- Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
- Taking anti-inflammatory medications on a daily basis;
- Currently experiencing intense stressful events/ life changes;
- Currently in intensive athletic training (such as marathon runners);
- Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
- An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
- Unwilling to maintain a constant intake of supplements over the duration of the study;
- Anxiety about having blood drawn;
- Pregnant, nursing, or trying to become pregnant;
- Known food allergies related to ingredients in active test product or placebo.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- NIS Labs — Klamath Falls
Identifiers
NCT: NCT07195552 · 171-003