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| Name | Class |
|---|---|
| Natural Immune Systems Inc | OTHER |
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Clinical verification study evaluating the effects of a nutraceutical product. This study involves thirty participants composed of healthy adults, who will be taking either a placebo or nutraceutical supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the nutraceutical on immune function compared to a placebo.
Clinical study comparing the acute immune effect of a nutraceutical product and a placebo. The nutraceutical supplement is a postbiotic whole food fermentate produced using yeast.
30 subjects will participate in a placebo-controlled, double-blind, randomized, cross-over design, wherein they will be taking a placebo, or nutraceutical product, each separated by a 1-week washout period to evaluate effects within 3 hours of consumption.
Blood samples will be taken 1 hour after participants arrive, then the dose is administered. Samples are taken 1 hour, 2 hours, and 3 hours following administration.
A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, and cytokine profiles. Ex vivo immune challenges will be used to determine the direct impacts on immune cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo intervention first and Active intervention one week later | Experimental | Participants will be consuming a placebo on a clinic day at least one week prior to a clinic day where they will consume the active intervention. |
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| Active intervention first and Placebo intervention one week later | Experimental | Participants will be consuming active intervention on a clinic day at least 1 week prior to a clinic day where they will consume the placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yeast Fermentate (EpiCor) | Dietary Supplement | Dietary Supplement: Yeast Fermentate (EpiCor): Postbiotic whole food fermentate made using yeast. Composed of proteins, polyphenols, vitamins, minerals, amino acids, polysaccharides, fibre, and other nutrients. Placebo: Substance with no therapeutic value to facilitate blinding |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Surveillance | Observation of changes in immune cell trafficking and status of immune cell alertness, i.e., the changes in immune cell populations and activation following administration | At 1, 2, and 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Communication | Serum cytokine levels as assessed by changes in cytokine levels individually versus placebo | At 1, 2, and 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Responsiveness | Ex vivo immune challenges, observing the capabilities of anti-bacterial and anti-viral defenses. Additionally, mucosal immune protection as determined by salivary IgA, defensins, and transferrin changes. | At 1, 2, and 3 hours |
Inclusion Criteria:
Exclusion Criteria:
Prescription medication will be evaluated on case-by-case basis.
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| Name | Affiliation | Role |
|---|---|---|
| Gitte Jensen, PhD | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
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Placebo-controlled, randomized, double-blind, cross-over design.
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