A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 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 Catechin high contain greentea 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. 80 subjects were participated in Catechin high contain greentea extract or placebo group. To evaluate the changes of the evaluation items when Catechin high contain greentea extract was taken 12 weeks 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 have Korean Mini-Mental Status Examination(K-MMSE) result 25-28 points
- •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 with a history of clinically significant hypersensitivity to green tea
- •Those taking medicines, health functional foods or herbal medicines related to improvement of cognitive function and memory within 1 month before screening
- •Those who ingested green tea extract's health functional food within 1 month before screening
- •Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- •Those who participate in other human tiral within 3 months
- •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 is deemed unsuitable for participating in the human trial due to other reasons
研究组 & 干预措施
Catechin high contain greentea extract
Catechin high contain greentea extract for 260 mg/day 12 weeks.
干预措施: Catechin high contain greentea 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 week.
Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)
时间窗: 12 weeks
Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
次要结局
- Changes of Auditory continuous performance test(12 weeks)
- Changes of Verbal learning test(12 weeks)
- Changes of Visual working memory test(12 weeks)
- Changes of Perceived stress scale(PSS)(12 weeks)
- Changes of Brain-derived neurotrophic factor(BDNF)(12 weeks)
- Changes of Total antioxidant status(TAS)(12 weeks)
- Changes of Beck Depression Inventory(BDI)(12 weeks)
研究者
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital