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The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.
The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.
Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.
The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover Group 1, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D. |
|
| Crossover Group 2, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A. |
|
| Crossover Group 3, randomized | Experimental | Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B. |
|
| Crossover Group 4, randomized |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anthocyanin-rich berry extract | Dietary Supplement | 0.5 grams |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stem cell surveillance | Changes to the number of stem cells in the blood circulation (number of cells per mL blood). Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+. | Baseline, 1 hour, 2 hours after consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokine levels | Baseline, 1 hour, 2 hours after consumption |
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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:
Prescription medication will be evaluated on a case-by-case basis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gitte S Jensen, PhD | Contact | 541 884 0112 | Gitte@nislabs.com | |
| Alex Cruickshank | Contact | Alex@nislabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
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| ID | Term |
|---|---|
| D005638 | Fruit |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Randomized, double-blinded, placebo-controlled, acute cross-over study design.
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Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C. |
|
| Anthocyanin-rich flower/leaf extract | Dietary Supplement | 0.5 grams |
|
| Berry /leaf blend | Dietary Supplement | 0.5 grams |
|
| Placebo | Dietary Supplement | Placebo (white rice-based) |
|