Immune Surveillance
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAgaricus blazei
Agaricus blazei mushroom capsules. 2000 mg per serving
DIETARY_SUPPLEMENTReishi
Reishi mushroom capsules. 2000 mg per serving.
DIETARY_SUPPLEMENTTurkey Tail
Turkey tail mushroom capsules. 2000 mg per serving.
OTHERPlacebo
Placebo
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, placebo controlled, crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Communication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Cell Surveillance | 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: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune responsiveness | 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: * Monocytes * NK cells * NKT cells * T cells * nonNK nonT cells. Immune challenges ex vivo: Effect on anti-bacterial and anti-viral immune defense activity |
Countries
United States
Contacts
Primary ContactGitte S Jensen, PhD
Backup ContactAlex Cruickshank
Outcome results
None listed