Effect of Skate Skin Extract on Cognitive Function in Adults With Subjective Memory Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mini-Mental State Examination total score
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.
详细描述
Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Global Deterioration Scale (GDS) 2 or 3
排除标准
- •Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
- •Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- •History of viral hepatitis or cancer
- •Uncontrolled hypertension
- •History of serious cardiac disease such as angina or myocardial infarction
- •History of gastrectomy
- •History of medication for psychiatric disease
- •Administration of oriental medicine including herbs within the past 4 weeks
结局指标
主要结局
Mini-Mental State Examination total score
时间窗: Change from Baseline Mini-Mental State Examination total score at 3 months
Change in Mini-Mental State Examination total score during 3 months
次要结局
- Korean instrumental activity of daily living total score(Change from Baseline Korean instrumental activity of daily living total score at 3 months)
- Computerized NeuroCognitive Function test total score(Change from Baseline Computerized NeuroCognitive Function test total score at 3 months)
- brain derived neurotrophic factor(Change from Baseline brain derived neurotrophic factor level at 3 months)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital