A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes of Natural killer(NK) cell activity
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
详细描述
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 40 subjects were randomly divided into Allium Cepa L. Peel Heated Water Extract or a placebo group. Immunity Enhancement profiles before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-75 years
- •Symptoms of upper respiratory infection at least once within past 12 months
排除标准
- •Cardio-cerebrovascular, endocrine, immune, respiratory, musculoskeletal, inflammatory, hematologic, tumorigenic, gastrointestinal diseases, etc.
- •Vaccination within past 2 months
- •BMI < 18.5 kg/m2 or 35 kg/m2 ≤ BMI
- •Immunity enhancement agents within past one months
- •Allergic or hypersensitive to any of the ingredients in the test products
- •Antipsychotic drugs therapy within past 3 months
- •History of alcoholism or drug abuse
- •Participation in any other clinical trials within past 3 months
- •Pregnant or lactating women
- •Judged ineligible to participate in the trial by the principal investigator
结局指标
主要结局
Changes of Natural killer(NK) cell activity
时间窗: At week 0 and week 8
Changes of Natural killer(NK) cell activity will be assessed before and after the intervention. PBMCs were isolated by density gradient separation, resuspended in phosphate-buffered saline, and determined using trypan blue solution. Natural killer(NK) cell activity was calculated from the results of nonradioactive cytotoxicity assay kits. Effector cells (PBMCs) were seeded in 96-well plates, with 50 ul of target cells (K562), incubated for 4 hours. cytotoxicity was calculated using the following formula: \[(experimental-effector spontaneous-target spontaneous)/(target maximum-target spontaneous)\]\*100.
次要结局
- Changes of Wisconsin Upper Respiratory Symptom Survey-21(At week 0 and week 4 and week 8)
- Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta)(At week 0 and week 8)
研究者
Yongsoon Park
Professor
Hanyang University