Angelica Gigas Dietary Supplements and Human Immune Cells

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03630328

Collaborator

(none)

Enrollment

Location

Arms

53.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Innate Immune Cells	Dietary Supplement: Cogni.Q Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 6, 2019

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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	Dietary Supplement: Cogni.Q AGN Other: Placebo Placebo
Placebo Comparator: Placebo Two capsules in the morning and two capsules in the evening for 21 days	Dietary Supplement: Cogni.Q AGN Other: Placebo Placebo

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

Dietary Supplement: Cogni.Q

AGN

Other: Placebo

Placebo

Placebo Comparator: Placebo

Two capsules in the morning and two capsules in the evening for 21 days

Dietary Supplement: Cogni.Q

AGN

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts 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