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NCT Number: NCT07195552

Clinical Trial: 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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location status: Recruiting

Location contact

Gitte S Jensen, PhD

CONTACT

[email protected]

541-884-0112

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Agaricus blazei

Dietary Supplement

Agaricus blazei mushroom capsules. 2000 mg per serving

Reishi

Dietary Supplement

Reishi mushroom capsules. 2000 mg per serving.

Turkey Tail

Dietary Supplement

Turkey tail mushroom capsules. 2000 mg per serving.

Placebo

Other

Placebo

Primary outcomes

  1. Immune Communication

    Time frame: 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 outcomes

  1. Immune Cell Surveillance

    Time frame: 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

Other outcomes

  1. Immune responsiveness

    Time frame: 2 hours after consuming a test product for this study protocol

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Cruickshank

CONTACT

Gitte S Jensen, PhD

CONTACT

[email protected]

5418820112

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

Clinical Trail: Rapid Immune Modulating Effects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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