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This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune cells: neutrophils that kill bacteria and other germs and natural killer (NK) cells that kill virus-infected cells and cancers. The investigators had done an earlier study with Korean Angelica supplement and discovered even a single dose of it increased blood neutrophils and NK cells within 24 h. In the new study, Korean Angelica capsules (Cogni.Q) will be compared head-to-head with dummy (placebo) capsules. This is to make sure the immune boosting actions are really from the Korean Angelica supplement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cogni.Q | Experimental | 800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days |
|
| Placebo | Placebo Comparator | Two capsules in the morning and two capsules in the evening for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cogni.Q | Dietary Supplement | AGN |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil counts and NK cell counts in peripheral blood | Using CBC diff to measure neutrophil counts, NK cells number will be enumerated using flowcytometer | 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| T cells in peripheral blood, | T cells number will be enumerated using flowcytometer | 70 days |
| Plasma concentrations of pyranocoumarins, androgens, and inflammatory/anti-inflammatory cytokines. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junxuan Lu, Ph.D. | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2018 | Aug 9, 2018 | Prot_SAP_000.pdf |
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| Other |
Placebo |
|
Determine Plasma concentrations of pyranocoumarins (as compliance marker), androgens, and inflammatory/anti-inflammatory cytokines.
| 70 days |
| Lipid profiling | blood test will be done at every visit | 70 days |
| NK mRNA signature | NK mRNA signature by RNA-seq transcriptomics using RNA prepared from Pax Gene tube-preserved whole blood collected on each visit | 70 days |
| PBMC isolation for testing NK activity | PBMCs will be isolated at every blood draw and kept frozen. They will be used to determine NK cell activity in future. | 70 days |
| CMP-EGFR | blood test will be done at every visit | 70 days |