Recruiting

Agaricus, Reishi, Turkey Tail

Sponsor:

Natural Immune Systems Inc

Code:

NCT07195552

Conditions

Immune Surveillance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Agaricus blazei

Reishi

Turkey Tail

Placebo

Study Details

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.

Conditions

Immune Surveillance

Study ID

NCT07195552

Start date

Jul 1, 2024

Status verified date

Sep, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Agaricus blazei

Agaricus blazei mushroom capsules. 2000 mg per serving

Reishi

Reishi mushroom capsules. 2000 mg per serving.

Turkey Tail

Turkey tail mushroom capsules. 2000 mg per serving.

Placebo

Placebo

Primary outcome measure

  • Immune Communication [ Time Frame: 2 hours after consuming a test product for this study protocol ]

Central Contacts and Locations

Central contacts

Gitte S Jensen, PhD

5418820112gitte@nislabs.com

Locations

NIS Labs

Recruiting

Klamath Falls, Oregon, United States, 97601

Contacts

Gitte S Jensen, PhD

541-884-0112Gitte@nislabs.com

More Information

Sponsor

Natural Immune Systems Inc

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Natural Immune Systems Inc on 2025-09-26.