Influence of the Dietary Supplement Luteolin for Two Weeks on Memory in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Visual Memory Test
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of the dietary supplement luteolin in healthy people. The main question it aims to answer is: Does luteolin have an influence on memory functions?
Participants will go trough two treatment phases. In one phase they will take 250mg luteolin twice daily for two weeks. In the other phase they will take a placebo twice daily for two weeks. A placebo is a look-alike substance that contains no active drug.
At the start and end of teach treatment phase, participants will undergo different memory testing exercises in our research facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female
- •able to give written informed consent as documented by signature
- •Aged: 18 to 40 years
- •normotensive (BP 90/60mmHg to 140/90mmHg)
- •BMI ≤ 30 kg/m2
排除标准
- •bodyweight <50 kg
- •pregnant or lactating women
- •intention to become pregnant during the course of the study
- •known or suspected non-compliance, drug or alcohol abuse
- •MADRS-S total score > 12 or MADRS-S item 9 >1
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
- •participation in another study with investigational drug within the 30 days preceding and during the present study
- •participation in one of our previous studies using the same memory tests in the past 2 years or participation in our first luteolin study in 2020
- •enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Visual Memory Test
时间窗: short delay (5 minutes), long delay (14 days): to assess differences between these time points
Performance in a visual memory test (Rey-Osterrieth complex figure test (Rey 1941) and (Osterrieth 1944)). As parallel version we will use the modified complex Taylor figure test (Hubley 2002). Participants will have to copy the complex figure. After a short delay of 5 minutes, they will be asked to redraw the figure from memory. A long-delayed recall test will be administered 2 weeks after the learning phase. Performance is calculated by scoring for accuracy and relative position of the 18 units in the whole of the design. Maximal score is 36 points.
次要结局
- Working Memory Test(after each treatment phase (duration two weeks))
- Anxiety(after each treatment phase (duration two weeks))
- Visual Analog Scales Quality of Sleep(after each treatment phase (duration two weeks))
- Depressive Symptoms(after each treatment phase (duration two weeks))
- Verbal Memory Task(immediate recall, short delay (10 minutes), long delay (14 days): to assess differences between these time points)
- Mood State (MDBF)(after each treatment phase (duration two weeks))
研究者
Prof. Dominique de Quervain, MD
Director Division of Cognitive Neuroscience
University of Basel