NCT05733364已完成不适用
Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年3月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of the intervention in improving Motivation
研究概览
简要总结
To evaluate the efficacy of the intervention in improving Motivation.
To evaluate the efficacy of the intervention in improving Fatigue, Motivation/Vigor, Focus/Sustained Attention and blood levels of B vitamins and taurine.
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
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female, aged 25-40 years, inclusive, at enrolment.
- •Healthy as per site physician/investigator medical assessment based on medical history and physical examination.
- •Body mass index (BMI) between 18.5 to 27.5 kg/m².
- •Able to understand and provide signed informed consent prior to study enrolment.
- •Willing and able to comply with the requirements for participation in this study.
- •Day time workers who work ≥ 8 and ≤ 12 hours per day, and ≤ 60 hours per week.
排除标准
- •Any significant ongoing or past medical (including celiac disease, obstructive sleep apnea, restless leg syndrome) and/or psychiatric condition, which in the opinion of the site physician/investigator may compromise participant wellbeing/safety, impede participant compliance with study procedures, or ability to complete the study.
- •Any clinically significant abnormality detected by the site physician/investigator during physical examination conducted at screening.
- •Participants with reported intermediate visual acuity less than 20/25 and without correction.
- •Known history of allergy to the ingredients in the investigational products.
- •Participants that have taken part in another interventional clinical trial within the last 3 months.
- •Current regular smoker (regularity defined ≥2 cigarettes per week).
- •Pregnant, lactating, or intending to conceive during the clinical trial.
- •Use of chronic over the counter or prescription medicines that may affect cognitive and physical functioning within 30 days or 5 half-lives prior to enrolment e.g., antidepressants, anxiolytics, antihistamines, narcotic analgesics.
- •Alcohol consumption above daily recommended alcohol intake for men (2 drinks = 24 g/day) and women (1 drink = 12 g/day) (assessed by self-report; local guidelines)
- •Caffeine consumption above recommended caffeine daily consumption, defined as > 400 mg/day (approximately 4 cups of coffee), and evaluated using the Caffeine Consumption Questionnaire.
- •Consumption of energy drinks containing Taurine and/or Vitamin Bs within 21 days prior to enrolment
- •Use of vitamin Bs and/or Whey protein and/or amino acid supplements within 30 days of enrolment.
- •Presence of sleep disorders (evaluated using the global sleep assessment questionnaire (GSAQ))
- •Performing shift work or trans-meridian travel within 10 days of enrolment
结局指标
主要结局
To evaluate the efficacy of the intervention in improving Motivation
时间窗: 28 days
The mean change from baseline to day 28 of product intake across sessions in the Monetary Incentivized Delay Task (MIDT). Assessment will be recorded as number of success over total in fraction or in %
次要结局
- To evaluate the efficacy of the intervention in improving Motivation(28 days)
- To evaluate the efficacy of the intervention in improving Fatigue.(28 days)
- To evaluate the efficacy of the intervention in improving Focus(28 days)
- To evaluate the efficacy of the intervention in improving Vigor.(28 days)
研究者
研究点 (2)
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