Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Verbal memory task
研究概览
简要总结
Randomized, blind parallel group design. Single intake of 55 g high Epicatechin /Melissa dark chocolate containing 160 mg Epicatechin per 55 g serving or single intake of 55 g low Epicatechin/ oat bran white chocolate containing < 0,00045 mg Epicatechin per 55 g serving.
A Total of 128 participants, 64 in each group, approx. equal number of male and female. There will be replacement of Drop-Outs until data from 128 participants are completed.
The primary endpoints will be performance in a pictorial memory task and a verbal memory task .
The secondary endpoints will be performance in a working memory test, Saliva cortisol, Visual analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy by history
- •normotensive (BP between 90/60 mmHg and 140/90 mmHg)
- •BMI between 18 and < 30 kg/m2
- •male or female
- •aged between 18 and 30 years
- •native or fluent German-speaking
- •Prüfungsangstfragebogen (PAF) total or subscale interference score T value > 60
排除标准
- •Known hypersensitivity or allergy to cocoa, Melissa, oat, vanillin, milk, soja, nuts
- •gluten intolerance
- •lactose intolerance
- •acute or chronic psychiatric disorder including drug or alcohol abuse
- •women who are pregnant or breast feeding
- •any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc., infections)
- •known or suspected non-compliance
- •smoking (> 5 cigarettes per day)
- •participation in one of our previous studies using the same memory tests in the past 2 years
- •participation in a study with investigational drug within the 30 days preceding and during the present study
- •long-term medication within last 3 months (oral contraceptives are disregarded)
结局指标
主要结局
Verbal memory task
时间窗: 25 minutes and 24 h after presentation
Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words
Pictorial memory task
时间窗: 25 minutes and 24 h after presentation
Participants will be presented with 24 neutral, 24 positive and 24 negative photographs in a random order. Scores will be calculated by summing the correctly remembered photographs per valence.
次要结局
- Saliva cortisol level(1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.)
- Visual Analogue Scale VAS confidence(1 day after word/picture presentation)
- Visual Analogue Scale VAS solicitude(1 day after word/picture presentation)
- Visual Analogue Scale VAS test anxiety(1 day after word/picture presentation)
- Visual Analogue Scale VAS interference(1 day after word/picture presentation)
- Working memory(1 day after word/picture presentation)
- Visual Analogue Scale VAS excitement(1 day after word/picture presentation)
研究者
Prof. Dominique de Quervain, MD
Prof. Dominique de Quervain, MD
University of Basel