Study of Angelica Gigas Dietary Supplements (Cogni.Q) and Potential Effects on Human Immune Cells
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neutrophil counts and NK cell counts in peripheral blood
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Cogni.Q
800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days
干预措施: Cogni.Q (Dietary Supplement)
Cogni.Q
800 mg per day (Two 200 mg capsules in the morning and two 200 mg capsules in the evening) for 21 days
干预措施: Placebo (Other)
Placebo
Two capsules in the morning and two capsules in the evening for 21 days
干预措施: Cogni.Q (Dietary Supplement)
Placebo
Two capsules in the morning and two capsules in the evening for 21 days
干预措施: Placebo (Other)
结局指标
主要结局
Neutrophil counts and NK cell counts in peripheral blood
时间窗: 70 days
Using CBC diff to measure neutrophil counts, NK cells number will be enumerated using flowcytometer
次要结局
- Lipid profiling(70 days)
- NK mRNA signature(70 days)
- T cells in peripheral blood,(70 days)
- CMP-EGFR(70 days)
- Plasma concentrations of pyranocoumarins, androgens, and inflammatory/anti-inflammatory cytokines.(70 days)
- PBMC isolation for testing NK activity(70 days)
研究者
Junxuan Lu
Professor of Pharmacology
Milton S. Hershey Medical Center