Clinical trial NCT03630328: Angelica Gigas Dietary Supplements and Human Immune Cells
Official title: Study of Angelica Gigas Dietary Supplements (Cogni.Q) and Potential Effects on Human Immune Cells
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Innate Immune Cells
Keywords: Cogni.Q
immune enhancement
natural killer cells
NK cells
Korean Angelica gigas
AGN
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 40
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Neutrophil counts and NK cell counts in peripheral blood
timeFrame: 70 days
Secondary outcomes:
measure: T cells in peripheral blood,
timeFrame: 70 days
measure: Plasma concentrations of pyranocoumarins, androgens, and inflammatory/anti-inflammatory cytokines.
timeFrame: 70 days
measure: Lipid profiling
timeFrame: 70 days
measure: NK mRNA signature
timeFrame: 70 days
measure: PBMC isolation for testing NK activity
timeFrame: 70 days
measure: CMP-EGFR
timeFrame: 70 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Junxuan Lu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: