A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
研究概览
简要总结
This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy without any uncontrolled or chronic disease.
- •Must consume a beverage containing low to moderate amount of caffeine once daily, defined as consuming the caffeine equivalent of less than or equal to one cup of coffee daily.
- •Looking for healthier alternatives to caffeine.
- •Currently owns a wearable sleep tracking device (e.g. Fitbit, Whoop, Oura etc) and has been wearing consistently for 4 weeks.
- •Resident of the USA.
排除标准
- •Allergies to any of the ingredients in the three products.
- •Anyone with a formal diagnosis of insomnia.
- •Any pre-existing or chronic conditions that would prevent participants from adhering to the protocol.
- •Women that are pregnant, breastfeeding or attempting to conceive during the duration of the trial.
- •Unwilling to follow the protocol.
- •Participants that consume more than two caffeinated drinks daily.
- •Participants that have little to no caffeine daily, equivalent to less than 1 cup of coffee daily.
- •Is not a resident of the USA.
结局指标
主要结局
Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4]
时间窗: 4 weeks
All participants will wear a sleep tracking device (e.g. Fitbit, Whoop, Oura etc) to record their total time asleep each night.
Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12]
时间窗: 12 weeks
Measured via study-specific questionnaires. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4]
时间窗: 4 weeks
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating and maintaining sleep, difficulty waking, and sleep satisfaction. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always").
次要结局
- Changes in self-reported caffeine side effects,(12 weeks)