The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Verbal Memory: Immediate recall score
研究概览
简要总结
Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive domains has not been rigorously studied. From the widespread use of caffeine, to the more questionable and increasing use of prescription medications to achieve peak attention, the tremendous interest in achieving cognitive performance has driven individuals to experiment, often with prescription and illegal drugs. Herein, we aim to standardize and extend the study of attention modulating substances, to identify blends that achieve safe enhancements in attention and working memory. Specific to this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe compounds to improve attention and working memory in normal, healthy individuals. CAF+ is composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).
详细描述
Rationale: There is still a great need to find treatments that can improve cognitive function in people that suffer from memory and attention problems, as well as healthy, young individuals. There are various natural ingredients that have been claimed to improve cognitive functions in humans (e.g., caffeine, L-theanine, vinpocetine). These ingredients have a different mechanism of action and are assumed to have a general effect on brain function. It is hypothesized that a combination of these natural ingredients may be more effective to improve cognitive performance. In this study we would like to test the cognition-enhancing potential of a mixture of different natural ingredients.
Objective: Examine the effects of a treatment that consists of different natural ingredients on cognitive performance in young healthy subjects. These effects will be compared with caffeine treatment, a natural ingredient that has been found to improve cognition in various studies.
Study design: This study will use a double-blind placebo controlled, cross-over design.
Study population: Twenty-one healthy subjects in the age range from 18-35 years will be included.
Intervention: The subjects will be tested three times. At each test session they will receive one capsule (Placebo, Caffeine, or CAF+).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5-30
- •Willing to sign informed consent
排除标准
- •Suffer from or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness (Also those volunteers who have a first-degree relative with a psychiatric disorder or a history with a psychiatric disorder will be excluded)
- •Alcohol consumption >20 drinks/week
- •pregnant or lactating
- •use of medication of than oral contraceptives
- •use of recreation drugs 2 weeks before until the end of the experiment
- •any motor or sensory deficits which could reasonably be expected to affect test performance
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Caffeine-alone
The effects of the combination will be compared to both placebo and caffeine-alone, to test the hypothesis that the blend of ingredients will enhance cognitive measures greater than the most commonly used cognitive enhancer, caffeine.
干预措施: Caffeine-alone (Dietary Supplement)
CAF+
干预措施: CAF+ (Dietary Supplement)
结局指标
主要结局
Verbal Memory: Immediate recall score
时间窗: Up to 12 weeks
Verbal Memory will be assessed by an adjusted version of the Rey Auditory Verbal Learning Test (Lezak, 1995): the visual verbal learning test (Riedel, Klaassen, Deutz, van Someren, \& van Praag, 1999). This test consists of a list of 30 Dutch monosyllabic words (18 nouns, 12 adjectives) of which subjects have to remember as many as possible. All words are presented one by one on a computer screen, in three trials with the same item sequence. After each trial, the subjects are asked to name as many words as they can (immediate recall). Thirty minutes after the third trial, the subject is requested to recall as many words as possible (delayed recall). Next to the delayed recall, a recognition test will be assessed, consisting of all former and 30 comparable new words. Subjects are asked to respond whether they have seen the word during the learning trials by means of pressing a "yes" or a "no" button.
次要结局
- Complex-scanning and visual tracking(Up to 12 weeks)
- Working memory(Up to 12 weeks)
- Simple and -choice reaction time(Up to 12 weeks)
- Verbal Memory: Delayed recall score(Up to 12 weeks)
- Response inhibition and focused attention(Up to 12 weeks)