Clinical Trial: Rapid Immune Modulating Effects

Clinical Trail: Rapid Immune Modulating Effects

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Surveillance
• Intervention / Treatment: Other: Placebo; Dietary supplement: Agaricus blazei; Dietary supplement: Reishi; Dietary supplement: 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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Cruickshank
• Study Contact Backup: Name: Gitte S Jensen, PhD; Phone Number: 5418820112; Email: Gitte@nislabs.com

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • NIS Labs
      • Contact: Gitte S Jensen, PhD; Phone Number: 541-884-0112; Email: Gitte@nislabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crossover group 1, randomized; 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.	Other: Placebo; Placebo; 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.
Experimental: Crossover group 2, randomized; 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.	Other: Placebo; Placebo; 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.
Experimental: Crossover group 3, randomized; 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.	Other: Placebo; Placebo; 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.
Experimental: Crossover group 4, randomized; 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.	Other: Placebo; Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours after consuming a test product for this study protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours after consuming a test product for this study protocol

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours after consuming a test product for this study protocol

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Estimated): September 26, 2025

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 171-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No