Angelica Gigas Dietary Supplements and Human Immune Cells
- Conditions
- Innate Immune Cells
- Interventions
- Dietary Supplement: Cogni.QOther: Placebo
- Registration Number
- NCT03630328
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 40
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cogni.Q Cogni.Q 800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days Placebo Cogni.Q Two capsules in the morning and two capsules in the evening for 21 days Cogni.Q Placebo 800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days Placebo Placebo Two capsules in the morning and two capsules in the evening for 21 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
T cells in peripheral blood, 70 days T cells number will be enumerated using flowcytometer
CMP-EGFR 70 days blood test will be done at every visit
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.
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.
Trial Locations
- Locations (1)
Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States