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The goal for this clinical trial is to document rapid effects of a nutritional blend on immune cells. A double-blind, placebo-controlled, cross-over study design will be used.
Clinical trial comparing the acute immune effects of a nutraceutical blend, and a placebo. The nutraceutical blend is based on low molecular weight peptides isolated from cow colostrum ultrafiltrate, mushroom extracts, and vitamin C.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be consuming placebo or the active nutraceutical blend, separated by a 1-week washout period.
Baseline blood samples are taken 1 hour after participants arrive; the dose is then administered. Additional blood samples are taken 1 hour, 2 hours, and 3 hours following consumption of test product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Crossover group 1, randomized | Experimental | Crossover study: Participants consume a test product on each of the two clinic visits, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume the active test product versus placebo over 2 weeks. The order of interventions for this group is A, B. |
|
| Experimental: Crossover group 2, randomized | Experimental | Crossover study: Participants consume a test product on each of the two clinic visits, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume the active test product versus placebo over 2 weeks. The order of interventions for this group is B, A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Four capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune cell surveillance | Observation 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:
| 3 hours after consuming a test product for this study protocol |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 hours after consuming a test product for this study protocol |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gitte S. Jensen, PhD | Contact | 15418840112 | gitte@nislabs.com |
| Name | Affiliation | Role |
|---|---|---|
| Gitte S. Jensen, PhD | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Recruiting | Klamath Falls | Oregon | 97601 | United States |
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Double-blinded, placebo-controlled, cross-over study design.
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Participants will not be informed on which intervention they consume on a given clinic visit.
| Nutraceutical blend | Dietary Supplement | Four capsules. |
|