Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 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 Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, 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
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 65 years old
- •Able to give informed consent
排除标准
- •History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease
- •Subjects with medical conditions such as Severe Dementia
- •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 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).
Changes in ability to perform working memory tasks
时间窗: 12 weeks
Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in CNT(Computerized neurocognitive function test)(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