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Clinical-proof-of concept study, comparing the acute immune impacts of of 2 doses of a novel blend of supplements to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 2 different doses of the blend at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the blend on immune function as compared to the placebo.
Clinical-proof-of-concept study comparing the acute immune effects of 2 doses of a nutraceutical blend, and a placebo. The nutraceutical blend is based on a transfer factor isolated from cow colostrum ultrafiltrate.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.
Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, a spit sample will also be taken for salivary IgA testing.
A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention. |
|
| Group B | Experimental | Crossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfer factor from colostrum ultrafiltrate | Dietary Supplement | Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune communication | Observation of changes in serum cytokine levels | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Surveillance and Alertness | Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration. | 2 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. | 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Recruiting | Klamath Falls | Oregon | 97601 | United States |
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Placebo-controlled, double-blinded, cross-over study design.
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Participants will not be informed on which intervention they receive on any given day.