Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID07195552

Clinical Trial: Rapid Immune Modulating Effects Comparing Agaricus, Reishi, and Turkey Tail Mushrooms to Placebo

Led by Natural Immune Systems Inc · Updated on 2025-09-26

12

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the immediate immune effects of three medicinal mushrooms—Agaricus blazei, Reishi, and Turkey Tail—compared to a placebo in healthy adults aged 18 to 75. The study focuses on how these mushrooms influence immune cell communication, including pro- and anti-inflammatory signals, immune cell alertness, and immune surveillance, which are natural parts of the body's immune cycles. Participants take part in a crossover study where each person consumes one of the test mushroom products or a placebo on four separate clinic days, each at least one week apart to allow for a washout period. The mushroom capsules are given at a dose of 2000 mg per serving. The order in which participants receive the mushrooms and placebo varies among four different randomized groups over four weeks. During the study, participants undergo blood draws and other evaluations two hours after taking each test product to measure immune communication and immune cell surveillance. They follow specific routines including consistent diet and lifestyle habits, bland breakfasts before visits, and abstaining from exercise, certain beverages, and distractions during clinic visits. The study includes safety monitoring and lasts about four weeks in total, with each visit spaced to allow clear comparison between the mushrooms and placebo effects.

CONDITIONS

Brief Title

Clinical Trial: Rapid Immune Modulating Effects

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults
  • Age 18 to 75 years inclusive
  • Veins easy to see in one or both arms for blood draws
  • Willing to maintain consistent diet and lifestyle during the study
  • Able to eat bland breakfasts on study clinic days
  • Able to abstain from exercise and nutritional supplements on mornings of clinic visits
  • Able to avoid coffee, tea, and soft drinks for at least one hour before visits
  • Able to avoid music, candy, gum, and use of computers or cell phones during clinic visits
Not Eligible

You will not qualify if you...

  • Previous major gastrointestinal surgery (minor surgeries like appendix or gall bladder removal allowed)
  • Taking anti-inflammatory medications daily
  • Experiencing intense stressful events or life changes
  • Engaged in intensive athletic training like marathon running
  • Taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa, or Seroquel
  • Having an unusual sleep routine (e.g., graveyard shifts, irregular late nights)
  • Unwilling to maintain constant supplement intake during the study
  • Anxiety about blood draws
  • Pregnant, nursing, or trying to become pregnant
  • Known food allergies related to ingredients in the test products or placebo

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants consume one of four test products (Agaricus blazei, Reishi, Turkey Tail mushrooms, or placebo) on each of four clinic days. Each clinic day is at least one week apart to allow for a wash-out period between products.

4 visits (in-person), one visit per week

Trial Site Locations

Total: 1 location

1

NIS Labs

Klamath Falls, Oregon, United States, 97601

Actively Recruiting

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Research Team

G

Gitte S Jensen, PhD

A

Alex Cruickshank

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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