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| Name | Class |
|---|---|
| Applied Food Sciences Inc. | INDUSTRY |
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The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.
This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.
Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover group 1, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is A, C, B, D, E. |
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| Crossover group 2, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is E, A, C, B, D. |
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| Crossover group 3, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is D, E, A, C, B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 2 capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Stem cell trafficking | 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, and 3 hours after ingestion of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial volume per cell | Mitochondrial volume per cell under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye MitoTracker is used to obtain relative measures of mitochondrial volume per cell using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells. |
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Inclusion Criteria:
Healthy adults;
Age 18 - 75 years (inclusive);
BMI between 18.0 and 34.9 (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 | 5418820112 | Gitte@nislabs.com | |
| Alex Cruickshank | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Recruiting | Klamath Falls | Oregon | 97601 | United States |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
| C000627506 | olive extract |
| C402622 | potassium hydrogen glucarate |
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Placebo-controlled, randomized, double-blinded, cross-over study design.
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| Crossover group 4, randomized | Experimental | Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is B, C, D, A, E. |
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| Chaga Mushroom | Dietary Supplement | 2 capsules |
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| Ginseng extract | Dietary Supplement | 2 capsules |
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| Olive extract | Dietary Supplement | 2 capsules |
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| Potassium Hydrogen Glucarate | Dietary Supplement | 2 capsules |
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| Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug |
| Mitochondrial membrane potential per cell | Cellular energy production under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye JC-1 is a fluorescent cationic dye used to obtain relative measures of mitochondrial membrane potential per cells, using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells. | Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug |