Efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, and Caffeine for Perceived Energy and Wakefulness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Subjective wakefulness levels based on assessment tool rankings
研究概览
简要总结
The line of "5-hour Energy"® products are available over-the-counter as energy supplements. The appeal of these products involves ease of use, low caloric value, and the absence of sugar to prevent a "crash" later in the day. The definitive efficacy and potency of the products is unknown due to the lack of evidence-based clinical reports. It is suspected that the efficacy related to these products is due to the caffeine content, which was reported as 138 mg per 2-ounce bottle in an online caffeine content chart. The purpose of this randomized, double-blind, placebo controlled, four way crossover study is to evaluate the efficacy of "5-hour Energy"®, "5-Hour Energy Decaf"®, caffeine, and placebo for perceived energy and wakefulness.
详细描述
Please see brief summary contained above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be age 18 years or older who consume no more than five caffeinated beverages and products per day. One caffeinated beverage is defined as any of the following: six ounces of cold or hot coffee or tea, twelve ounces of soda with caffeine, or one energy drink.
排除标准
- •Age less than 18 years
- •Subjects who are pregnant or breast-feeding
- •Diagnosis of any of the following disease states:
- •Attention Deficit Hyperactive Disorder
- •Coronary Artery Disease
- •Cardiac arrhythmias
- •Cerebral vascular accident
- •Narcolepsy
- •Seizure disorders
- •Uncontrolled hypertension
- •Active therapy with stimulant medications - any medications containing amphetamine, atomoxetine, dextroamphetamine, diethylpropion, lisdexamfetamine, methylphenidate, phentermine, or modafinil
- •Use of decongestants or other products containing phenylephrine or pseudoephedrine for more than 15 days within the past 30 days
- •Subjects who work third shift or rotate to two or more different shifts for their job, not allowing them to have a regular sleep schedule
结局指标
主要结局
Subjective wakefulness levels based on assessment tool rankings
时间窗: At one, three, and five hours after taking the study product
Subjects are provided with assessment tools to use for each product. The tool contains the Stanford Sleepiness Scale to assess for wakefulness levels. All appropriate options are listed, and subjects are required to circle one option at one, three, and five hours after taking the study product for the day.
次要结局
- Number of patients experiencing adverse effects associated with study products(Within five hours after taking study product)
研究者
Michelle Piel
Pharmacy Resident
ProMedica Health System