Effect of a Nootropic on the Cognitive Performance in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Simple and multiple reaction time
研究概览
简要总结
The main aim of this study is to determine the effect of a nootropic on cognitive performance (i.e., reaction time, inhibitory control, cognitive flexibility, working memory, neuro-psychological outcomes).
详细描述
Cognitive decline is a worrisome consequence of normal or pathologic ageing, having a high personal, eco- nomic and societal burden; also, it could herald the onset of dementia which is associated with significant morbidity and mortality.
However, with a general increase in life expectancy and a corresponding increase in the prevalence of age-related cognitive impairment, there have been concerted efforts towards the development and adoption of preventive strategies that would minimize the risk of developing dementia, or reduce the rate of cognitive decline with ageing. In the last few decades, certain compounds have been found useful in the management of cognitive decline.
The term 'nootropic' has been used to define such substances with the capacity to enhance cognition. While research has led to the synthesis of several drugs with nootropic effects, attention is now being shifted to the discovery, characterization and utilization of nootropics from natural sources for the prevention and management of age-related cognitive decline.
25 young adults will be randomized into two conditions (nootropic and placebo conditions) with 48 hours of separation between conditions. 48h previous to the randomization the participants will perform a familiarization to avoid the learning effects.
Each evaluation day will conform to the following tests:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Healthy male or female
- •Ages 18-30 years
- •BMI: 18-30.0 kg/m2
- •Stable weight over the last 3 months (body weight changes<3kg)
- •Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.
- •To talk and to read Spanish fluently.
排除标准
- •History of neurological disease or mental disease.
- •History of cardiovascular disease
- •Diabetes or hypertension
- •Pregnant, planning to become pregnant, or breastfeeding
- •Have been treated previously or during the study period with neurological drugs.
- •Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
- •Allergy/intolerance to any ingredient of the nootropic.
- •High caffeine consumes (>300mg/day, or >3 coffees/day).
- •Any non-controlled medical condition which could influence results or could be worsened by the participation in the study.
- •Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
结局指标
主要结局
Simple and multiple reaction time
时间窗: 1.5 hours
Vienna Test System®
次要结局
- Verbal fluidity(1.5 hours)
- Mood(1.5 hours)
- Positive and negative emotions(1.5 hours)
- Working Memory(1.5 hours)
- Motivation(1.5 hours)
- Adverse effects(1.5 hours)
- Creative Intelligence(1.5 hours)
- Working memory(1.5 hours)
- Inhibitory control(1.5 hours)
研究者
Jonatan Ruiz Ruiz
Associate professor
Universidad de Granada