A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 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 investigated the effects of daily supplementation of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity.
详细描述
This study was a 8-week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into Blueberry Yeast Fermentation Freeze Dying Powder extract 2.07 g or placebo group. The investigated measured Natural Killer cell activity, Cytokines, Upper respiratory infection questionnaire score, etc.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and women over 50 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 received influenza vaccination within 3 months before the screening
- •Those who have a body mass index(BMI) of less than 18.5 kg / m2 or greater than 35 kg / m2 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
- •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.
研究组 & 干预措施
Placebo
Placebo 2.07 g/day for 8 weeks.
干预措施: Placebo (Dietary Supplement)
Blueberry Yeast Fermentation Freeze Dying Powder Extract
Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.
干预措施: Blueberry Yeast Fermentation Freeze Dying Powder Extract (Dietary Supplement)
结局指标
主要结局
Changes of Natural Killer cell activity
时间窗: 8 week
Natural Killer cell activity was measured in study baseline and 8 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
次要结局
- Changes of Cytokines(8 week)
- Changes of Upper respiratory infection questionnaire score(8 week)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital