NCT07195552

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 10, 2025

Last Update Submit

September 19, 2025

Conditions

Immune Surveillance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Immune Cell Surveillance

    2 hours after consuming a test product for this study protocol

Other Outcomes (1)

  • Immune responsiveness

    2 hours after consuming a test product for this study protocol

Study Arms (4)

Crossover group 1, randomized

EXPERIMENTAL

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.

Dietary Supplement: Agaricus blazeiDietary Supplement: ReishiDietary Supplement: Turkey TailOther: Placebo

Crossover group 2, randomized

EXPERIMENTAL

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.

Dietary Supplement: Agaricus blazeiDietary Supplement: ReishiDietary Supplement: Turkey TailOther: Placebo

Crossover group 3, randomized

EXPERIMENTAL

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.

Dietary Supplement: Agaricus blazeiDietary Supplement: ReishiDietary Supplement: Turkey TailOther: Placebo

Crossover group 4, randomized

EXPERIMENTAL

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.

Dietary Supplement: Agaricus blazeiDietary Supplement: ReishiDietary Supplement: Turkey TailOther: Placebo

Interventions

Agaricus blazeiDIETARY_SUPPLEMENT

Agaricus blazei mushroom capsules. 2000 mg per serving

Crossover group 1, randomizedCrossover group 2, randomizedCrossover group 3, randomizedCrossover group 4, randomized
ReishiDIETARY_SUPPLEMENT

Reishi mushroom capsules. 2000 mg per serving.

Crossover group 1, randomizedCrossover group 2, randomizedCrossover group 3, randomizedCrossover group 4, randomized
Turkey TailDIETARY_SUPPLEMENT

Turkey tail mushroom capsules. 2000 mg per serving.

Crossover group 1, randomizedCrossover group 2, randomizedCrossover group 3, randomizedCrossover group 4, randomized
PlaceboOTHER

Placebo

Crossover group 1, randomizedCrossover group 2, randomizedCrossover group 3, randomizedCrossover group 4, randomized

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

Central Study Contacts

Gitte S Jensen, PhD

CONTACT

5418820112gitte@nislabs.com

Alex Cruickshank

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, placebo controlled, crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 26, 2025

Study Start

July 1, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)