An interventional study of Agaricus blazei and Reishi in Immune Surveillance, sponsored by Natural Immune Systems Inc. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Natural Immune Systems Inc · Not applicable, Interventional, and Basic science
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.
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.
Natural Immune Systems Inc is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is A, B, C, D.
Dietary Supplement: Agaricus blazei · Dietary Supplement: Reishi · Dietary Supplement: Turkey Tail · Other: Placebo
Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is B, D, A, C.
Dietary Supplement: Agaricus blazei · Dietary Supplement: Reishi · Dietary Supplement: Turkey Tail · Other: Placebo
Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is C, A, D, B.
Dietary Supplement: Agaricus blazei · Dietary Supplement: Reishi · Dietary Supplement: Turkey Tail · Other: Placebo
Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is D, B, A, C.
Dietary Supplement: Agaricus blazei · Dietary Supplement: Reishi · Dietary Supplement: Turkey Tail · Other: Placebo
Agaricus blazei mushroom capsules. 2000 mg per serving
Reishi mushroom capsules. 2000 mg per serving.
Turkey tail mushroom capsules. 2000 mg per serving.
Placebo
Immune Communication
Changes to serum cytokine levels. The testing involves a broad panel of pro- and anti-inflammatory cytokines, anti-viral peptides, and regenerative growth factors, using a 27-plex Luminex magnetic bead array and the MagPix® multiplexing system. The following cytokines are tested: IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17, eotaxin, basic FGF, G-CSF, GM-CSF, IFN-gamma, IP-10, MCP-1 (MCAF), MIP-1alpha, MIP-1beta, PDGF-BB, RANTES, TNF-alpha, and VEGF.
Time frame: 2 hours after consuming a test product for this study protocol
Immune Cell Surveillance
Documentation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells
Time frame: 2 hours after consuming a test product for this study protocol
Immune responsiveness
Immune cell activation status: Observation of immune cell status of alertness, i.e., the changes in the expression of CD25 and CD69. Data is collected as 'mean fluorescence intensity' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * nonNK nonT cells. Immune challenges ex vivo: Effect on anti-bacterial and anti-viral immune defense activity
Time frame: 2 hours after consuming a test product for this study protocol
Plan to share: No
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Natural Immune Systems Inc