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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06146517
• Other study ID #: 20341
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: January 22, 2024

Study information

• Verified date: November 2023
• Source: Clevr Blends
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: January 22, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 28 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Caffeine Withdrawal
• Mood
• Sleep

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Clevr Blends	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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