Innate Immune Cells
Conditions
Keywords
Cogni.Q, immune enhancement, natural killer cells, NK cells, Korean Angelica gigas, AGN
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCogni.Q
AGN
OTHERPlacebo
Placebo
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects weighing between 110 to 240 pounds; their body mass index (BMI) should be in the range of 19 to 30 * Subjects having normal hepatic, renal function as assessed by history, physical and clinical chemistry analysis (CMP eGFR, see supporting document for normal reference ranges). * Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)
Exclusion criteria
* Subjects positive for HIV, HBV and HCV (self-reported) * Subjects taking any kind of prescription medications regularly or within 10 days of the study will be excluded. Therefore, subjects with diabetes, major cardiovascular diseases, cancer, severe hypertension, severe hepatic cirrhosis or cirrhosis of the liver, and kidney disease (self-reported) will be excluded. * Subjects using tobacco products, nicotine patches and excessive alcohol * Subjects taking dietary or herbal supplements that contain AGN (e.g. Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) within 10 days of the study. * Non-English-speaking subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil counts and NK cell counts in peripheral blood | 70 days | Using CBC diff to measure neutrophil counts, NK cells number will be enumerated using flowcytometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T cells in peripheral blood, | 70 days | T cells number will be enumerated using flowcytometer |
| Plasma concentrations of pyranocoumarins, androgens, and inflammatory/anti-inflammatory cytokines. | 70 days | Determine Plasma concentrations of pyranocoumarins (as compliance marker), androgens, and inflammatory/anti-inflammatory cytokines. |
| Lipid profiling | 70 days | blood test will be done at every visit |
| NK mRNA signature | 70 days | NK mRNA signature by RNA-seq transcriptomics using RNA prepared from Pax Gene tube-preserved whole blood collected on each visit |
| PBMC isolation for testing NK activity | 70 days | PBMCs will be isolated at every blood draw and kept frozen. They will be used to determine NK cell activity in future. |
| CMP-EGFR | 70 days | blood test will be done at every visit |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJunxuan Lu, Ph.D.
Penn State College of Medicine
Outcome results
None listed