A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products
- Conditions
- MoodCaffeine WithdrawalProductivitySleepAnxiety
- Interventions
- Other: Clevr SleeptimeOther: Clevr MatchaOther: Clevr Chai
- Registration Number
- NCT06146517
- Lead Sponsor
- Clevr Blends
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
- Female.
- Age 28-42.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clevr Blends Arm Clevr Sleeptime Weeks 1-4: Participants will take one 6 oz serving daily of Clevr Blends Sleeptime 20 - 60 minutes before bed. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 5-8: Participants will take one serving daily of Clevr Blends Matcha, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 9-12: Participants will take one serving daily of Clevr Blends Chai, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Clevr Blends Arm Clevr Chai Weeks 1-4: Participants will take one 6 oz serving daily of Clevr Blends Sleeptime 20 - 60 minutes before bed. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 5-8: Participants will take one serving daily of Clevr Blends Matcha, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 9-12: Participants will take one serving daily of Clevr Blends Chai, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Clevr Blends Arm Clevr Matcha Weeks 1-4: Participants will take one 6 oz serving daily of Clevr Blends Sleeptime 20 - 60 minutes before bed. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 5-8: Participants will take one serving daily of Clevr Blends Matcha, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided. Weeks 9-12: Participants will take one serving daily of Clevr Blends Chai, before 1pm. The product comes with a scoop that measures 3 tsp. Participants should mix a full scoop with 6oz of water and froth using the frother that will be provided.
- Primary Outcome Measures
Name Time Method Changes in self-reported energy levels. [Timeframe: Baseline to Week 12] 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] 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] 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] 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").
- Secondary Outcome Measures
Name Time Method Changes in self-reported caffeine side effects, 12 weeks Measured via study-specific questionnaires reviewing jitters, caffeine crashes, anxiety, negative moods and dependency. Participants will answer on a Likert scale (0-5) with 0 indicating the best score and 5 indicating the worse score.
Trial Locations
- Locations (1)
Citruslabs
🇺🇸Santa Monica, California, United States