A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products

Conditions
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Sleep, Mood, Caffeine Withdrawal, Anxiety, Productivity

Intervention / Treatment
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* Other: Clevr Sleeptime
* Other: Clevr Matcha
* Other: Clevr Chai


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clevr Blends Arm<br>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. | Other: Clevr Sleeptime<br>* Participants will trial Clevr Blends Sleeptime during weeks 1-4.<br>Other: Clevr Matcha<br>* Participants will trial Clevr Matcha during weeks 5-8.<br>Other: Clevr Chai<br>* Participants will trial Clevr Chai during weeks 9-12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4] | All participants will wear a sleep tracking device (e.g. Fitbit, Whoop, Oura etc) to record their total time asleep each night. | 4 weeks | 
| Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4] | 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). | 4 weeks | 
| Changes in self-reported energy levels. [Timeframe: Baseline to Week 12] | 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. | 12 weeks | 
| Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12] | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-reported caffeine side effects, | 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. | 12 weeks |