NIS Labs
Klamath Falls, Oregon, 97601, United States
Location status: Recruiting
NCT Number: NCT07195552
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Klamath Falls, Oregon, 97601, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Agaricus blazei mushroom capsules. 2000 mg per serving
Reishi mushroom capsules. 2000 mg per serving.
Turkey tail mushroom capsules. 2000 mg per serving.
Placebo
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.
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:
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:
Immune challenges ex vivo:
Effect on anti-bacterial and anti-viral immune defense activity
Contact information is provided by the study sponsor or research team.
Natural Immune Systems Inc
Other
Clinical Trail: Rapid Immune Modulating Effects
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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