Influence of the Dietary Supplement Luteolin on Memory in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Memory Test
研究概览
简要总结
Proof of concept study on physiological processes (forgetting and memory functions, attention, working memory) in participants after multiple administration of the dietary supplement Luteolin.
详细描述
In the experimental phase the investigator will administer 500 mg Luteolin (2x250 mg capsules) per day formulated for oral administration for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning). The last intake on visits 2 resp. 4 is important as the participants then have to recall the learned material from visits 1 resp. 3 during a steady-state status of Luteolin.
Subjects will be randomly allocated to treatment groups (starting with investigational product or placebo).
Identity of Investigational Product: Luteolin extracted from Chrysanthemum Ramat 98% HPLC by Scyherb® food grade certified according to Safe Quality Foods (SQF) - Level 3 Comprehensive Food Safety and Quality Management System Certification by the Safe Quality Food Institute (SQFI).
Control intervention consists of identical looking placebo capsules containing mannitol formulated for oral administration to be taken twice daily (e.g. every morning and evening) for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning) with water.
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
- •normotensive (BP between 90/60mmHg and 140/90mmHg)
- •BMI <30 kg/m2
- •aged between 18 and 40 years
- •native or fluent German-speaking
- •able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
排除标准
- •Bodyweight <50 kg
- •acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency)
- •concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
- •women who are pregnant or breast feeding
- •intention to become pregnant during the course of the study
- •known or suspected non-compliance, drug or alcohol abuse
- •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
- •enrolment of the investigator, his/her family members, employees and other dependent persons
- •participation in one of our previous studies using the same memory tests in the past 2 years
- •Psychoactive drugs and alcoholic beverages 3 days (psychoactive drugs) resp. 12 hours (alcohol) before test visits 1-4.
研究组 & 干预措施
Control Intervention
Control intervention consists of identical looking placebo capsules containing mannitol formulated for oral administration to be taken twice daily (e.g. every morning and evening) for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning) with water.
干预措施: Placebo (Other)
Experimental intervention
In the experimental phase we will administer 500 mg Luteolin (2x250 mg capsules) per day formulated for oral administration for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning). The last intake on visits 2 resp. 4 is important as the participants then have to recall the learned material from visits 1 resp. 3 during a steady-state status of Luteolin.
干预措施: Luteolin (Dietary Supplement)
结局指标
主要结局
Visual Memory Test
时间窗: after 3 minutes, short delay (20 minutes), long delay (7 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 the modified complex Taylor figure test (Hubley 2002). Participants will have to copy the complex figure of Rey Osterrieth. After 3 and 20 minutes delay the subject will be asked to draw the figure from memory. 7 days after learning there will be a delayed recall. 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.
Verbal Memory Task
时间窗: immediate recall, short delay (15 minutes), long delay (7 days): to assess differences between these time points
Verbal memory task (de Quervain, Roozendaal et al. 2000). A parallel version will be used for the second study phase. Subjects will view series of 60 unrelated German nouns each presented for 4 s on a computer screen with the explicit instruction to learn them for immediate and delayed recall. For the free-recall test, subjects will be asked to write down all the words they remember. The number of correctly recalled words (hits) will be the relevant output. Delayed recall of all 60 words will be tested about 15 min (short delay) and 7 days (long delay, after treatment phase) after presentation.
次要结局
- Digit Span Task(after each treatment phase (duration one week) on vists 2 and 4)
- Visual Analog Scales Subjective Memory Function(after each treatment phase (duration one week) on vists 2 and 4)
- Visual Analog Scales Quality of Sleep(after each treatment phase (duration one week) on vists 2 and 4)
- Mode state (MDBF)(after each treatment phase (duration one week) on vists 2 and 4)
- Depressive symptoms(after each treatment phase (duration one week) on vists 2 and 4)
- Anxiety(after each treatment phase (duration one week) on vists 2 and 4)
研究者
Prof. Dominique de Quervain, MD
Director Divicion of Cognitive Neuroscience
University of Basel