Clinical Trial: Rapid Immune Modulating Effects

Not Applicable

Recruiting

• Conditions: Immune Surveillance

• Registration Number: NCT07195552
• Lead Sponsor: Natural Immune Systems Inc

Brief Summary

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.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Immune Communication	2 hours after consuming a test product for this study protocol	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.

Secondary Outcome Measures

Name	Time	Method
Immune Cell Surveillance	2 hours after consuming a test product for this study protocol	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

Trial Locations

Locations (1)

NIS Labs; 🇺🇸 Klamath Falls, Oregon, United States