Angelica Gigas Dietary Supplements and Human Immune Cells

Study Overview
=================
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.

Official Title
-----------------
Study of Angelica Gigas Dietary Supplements (Cogni.Q) and Potential Effects on Human Immune Cells

Conditions
-----------------
Innate Immune Cells

Intervention / Treatment
-----------------
* Dietary Supplement: Cogni.Q
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cogni.Q<br>800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days | Dietary Supplement: Cogni.Q<br>* AGN<br>Other: Placebo<br>* Placebo<br>|
| Placebo Comparator: Placebo<br>Two capsules in the morning and two capsules in the evening for 21 days | Dietary Supplement: Cogni.Q<br>* AGN<br>Other: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cogni.Q, immune enhancement, natural killer cells, NK cells, Korean Angelica gigas, AGN