Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Crossover group 4, randomized | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agaricus blazei | Dietary Supplement | Agaricus blazei mushroom capsules. 2000 mg per serving |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Cell Surveillance | 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:
| 2 hours after consuming a test product for this study protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Immune responsiveness | 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 | 2 hours after consuming a test product for this study protocol |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gitte S Jensen, PhD | Contact | 5418820112 | gitte@nislabs.com | |
| Alex Cruickshank | Contact |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Recruiting | Klamath Falls | Oregon | 97601 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, placebo controlled, crossover design
Not provided
Not provided
Not provided
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. |
|
| 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 |
|