Angelica Gigas Dietary Supplements and Human Immune Cells

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Innate Immune Cells
• Intervention / Treatment: Other: Placebo; Dietary supplement: Cogni.Q

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deepkamal N Karelia, Ph.D.; Phone Number: 285476 717-531-0003; Email: dkarelia@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cogni.Q; 800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days	Other: Placebo; Placebo; Dietary supplement: Cogni.Q; AGN
Placebo Comparator: Placebo; Two capsules in the morning and two capsules in the evening for 21 days	Other: Placebo; Placebo; Dietary supplement: Cogni.Q; AGN

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Junxuan Lu, Ph.D., Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: natural killer cells; NK cells; Cogni.Q; immune enhancement; Korean Angelica gigas; AGN
• Other Study ID Numbers: STUDY00008009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No