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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Anxiety; Mood; Caffeine Withdrawal; Productivity
• Intervention / Treatment: Other: Clevr Sleeptime; Other: Clevr Matcha; Other: Clevr Chai

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Clevr Blends Arm; 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; Participants will trial Clevr Blends Sleeptime during weeks 1-4.; Other: Clevr Matcha; Participants will trial Clevr Matcha during weeks 5-8.; Other: Clevr Chai; Participants will trial Clevr Chai during weeks 9-12.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clevr Blends
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No