A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Sesame Oil Cake Extract on Improvement of Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes of Visual learning test
研究概览
简要总结
This study was the efficacy and safety of Sesame oil cake extract on improvement of Cognitive Function
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 70 subjects were participated in Sesame Oil Cake Extract or placebo group. To evaluate the changes of the evaluation items when Sesame Oil Cake Extract was taken three times a day compared with placebo.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who are at least 60 years of age at screening
- •Those who word list memory / recollection/ recognition test scores of CERAD -K decrease 1-2 SD number of normal value
- •Those who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
排除标准
- •Those with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- •Those with alcohol abuse or dependence within the last 3 months
- •Those who have clinically significant following severe illness (Epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, Crohn's disease, etc.)
- •Those who shows the following results in the Laboratory test
- •AST, ALT > 3 times upper limit of normal range
- •Other significant laboratory test opinion
- •Those who take any prescription medicines or herbal medicines within 2 weeks before the first ingestion date or take any OTC or vitamin preparations within 1 week
- •Those who participate in other human trial within 2 months before the first ingestion
- •Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- •Those who is deemed unsuitable for participating in the human trial due to other reasons
研究组 & 干预措施
Sesame Oil Cake Extract
Sesame Oil Cake Extract 1.5 g/day for 12 weeks
干预措施: Sesame Oil Cake Extract (Dietary Supplement)
Placebo
placebo for 12 weeks
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Changes of Visual learning test
时间窗: 12 weeks
Visual learning test was measured in baseline and 12 weeks.
Changes of Visual working memory test
时间窗: 12 weeks
Visual working memory test was measured in baseline and 12 weeks.
Changes of Verbal learning test
时间窗: 12 weeks
Verbal learning test was measured in baseline and 12 weeks.
次要结局
- Changes of Oxidation index(8-OHdG)(12 weeks)
- Changes of the Montreal Cognitive Assessment(MoCA-K)(12 weeks)
- Changes of beta-amyloid(12 weeks)
研究者
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital