Efficacy and Safety of Wheat Bran Extract on Improvement of Cognitive and Memory Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)
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 water extract from wheat Triticum aestivum L on cognitive and memory function. The investigators measured changes in cognitive function parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF
详细描述
Based on reports about the neuroprotective effects of water extract from wheat Triticum aestivum L. or its bran, the investigators hypothesize that extract of wheat bran (WBE) is beneficial to elderly people with age-associated cognitive impairment. The investigators investigated the efficacy and safety of WBE on improvement of cognitive function through measuring the neuropsychometric assessments in adult with subjective cognitive impairment by a randomized clinical trial.
Seventy participants aged from 50 to 80 years old with subjective cognitive impairment were randomly assigned to receive either WBE (3,000 mg/day) in this 12-week, double-blind placebo-controlled and parallel trial. Neuropsychological assessments including Computerized Neurocognitive function test (CNT), Working Memory Test (WMT), Korean Mini-Mental State Examination (K-MMSE), Brief Cognitive Rating Scale (BCRS), Prospective and Retrospective Memory Questionnaire (PRMQ), Perceived Stress Scale (PSS), 36-Item of Short-Form Health Survey (SF-36) and blood Brain-derived neurotrophic factor (BDNF) were used to assess the cognitive function 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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects with subjective cognitive impairment
- •able to give informed consent
排除标准
- •history of underlying neurodegenerative disease
- •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.
结局指标
主要结局
Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)
时间窗: baseline and 12 weeks
次要结局
- Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)(baseline and 12 weeks)
- Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)(baseline and 12 weeks)
- Quality of life as assessed by the 36-item short-form healthy survey (SF-36) score(baseline and 12 weeks)
- Cognitive function as assessed by the Brain-Derived Neurotrophic Factor (BDNF)(baseline and 12 weeks)
- Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score(baseline and 12 weeks)
- Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)(baseline and 12 weeks)
- Visual subset of WMT (working memory test)(baseline and 12 weeks)
- Stress level evaluation as assessed by the Perceived stress scale (PSS)(baseline and 12 weeks)
研究者
Soo-Wan Chae
Professor
Chonbuk National University Hospital