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Completed

NCT Number: NCT06146517

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.

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Key information

Conditions

Sleep Anxiety Anxiety Disorders Caffeine Withdrawal Mental Disorders Mood Productivity

Age range

28 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clevr Sleeptime

Other

Participants will trial Clevr Blends Sleeptime during weeks 1-4.

Clevr Matcha

Other

Participants will trial Clevr Matcha during weeks 5-8.

Clevr Chai

Other

Participants will trial Clevr Chai during weeks 9-12.

Primary outcomes

  1. Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4]

    Time frame: 4 weeks

    All participants will wear a sleep tracking device (e.g. Fitbit, Whoop, Oura etc) to record their total time asleep each night.

  2. Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4]

    Time frame: 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").

  3. Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]

    Time frame: 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.

  4. Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12]

    Time frame: 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.

Secondary outcomes

  1. Changes in self-reported caffeine side effects,

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clevr Blends

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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