A 4 Weeks, Randomized, Double-blind Human Trial to Evaluate the Efficacy and Safety of Fermented Soybean(Doenjang Powder) on Intestinal Microflora and Immune Enhancement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Changes of Natural Killer cell activity
研究概览
简要总结
This study was conducted to investigate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.
详细描述
This study was a 4 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.
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
- 否
入选标准
- •Adult men and women over 19 and under 75 years
- •After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
排除标准
- •If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
- •Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
- •Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
- •Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
- •Those who have received antipsychotic medication within 3 months before screening
- •Those who alcoholic or drug abuse suspected
- •Those who participated in other clinical trials within 3 months before screening
- •Laboratory test by show the following results
- •Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dL
- •Pregnancy or breast feeding
- •Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- •Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
结局指标
主要结局
Changes of Natural Killer cell activity
时间窗: baseline and 4 weeks
Natural Killer cell activity was measured in study baseline and 4 week. A ratio of effector cell and target cell was 50:1, 25:1, 12.5:1. (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
Changes in intestinal microflora
时间窗: baseline and 4 weeks
Put more than 1 g of feces in the fecal kit, and perform analysis
次要结局
- Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha(baseline and 4 weeks)
- Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)(baseline and 4 weeks)
- Patient global assessment(PGA)(4 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital