Clinical Trial: Rapid Immune Modulating Effects
ConditionImmune Surveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNatural Immune Systems Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults;
Age 18-75 years (inclusive);
Veins easy to see in one or both arms (to allow for the multiple blood draws);
Maintaining a consistent diet and lifestyle routine throughout the study,
Disqualifiers
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);
Trial design
Design model
Crossover
Treatments tested in this trial
Agaricus blazei
Dietary supplementAgaricus blazei mushroom capsules. 2000 mg per serving
Reishi
Dietary supplementReishi mushroom capsules. 2000 mg per serving.
Turkey Tail
Dietary supplementTurkey tail mushroom capsules. 2000 mg per serving.
Placebo
Other interventionPlacebo
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: Crossover group 1, randomizedExperimental treatment 4 interventions
Group B: Crossover group 2, randomizedExperimental treatment 4 interventions
Group C: Crossover group 3, randomizedExperimental treatment 4 interventions
Group D: Crossover group 4, randomizedExperimental treatment 4 interventions
Trial outcomes
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.
Time frame
2 hours after consuming a test product for this study protocolSecondary outcomes
1
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: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells
Time frame
2 hours after consuming a test product for this study protocolOther outcomes
1
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: * Monocytes * NK cells * NKT cells * T cells * nonNK nonT cells. Immune challenges ex vivo: Effect on anti-bacterial and anti-viral immune defense activity
Time frame
2 hours after consuming a test product for this study protocolSponsors and contacts
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Source ClinicalTrials.gov