Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in K-MMSE(Korean Mini-Mental State Examination)
研究概览
简要总结
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.
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
- 16 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 16-19 years old
- •Weight within ±30% of ideal body weight
- •Able to give informed consent
排除标准
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
研究组 & 干预措施
Eriobotyra Japonica Lindley Extract
干预措施: Eriobotyra Japonica Lindley Extract (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in K-MMSE(Korean Mini-Mental State Examination)
时间窗: 12 weeks
K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in Rey-Kim Memory Test(12 weeks)
- Changes in PRMQ(Prospective and retrospective memory questionnaire)(12 weeks)
- Changes in STAI(State-trait anxiety inventory)(12 weeks)
- Changes in BDNF(Brain derived neurotrophic factor)(12 weeks)
- Changes in BCRS(Brief Cognitive Rating Scale)(12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital