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

Clevr Blends

Status: Completed

Conditions: Caffeine Withdrawal; Mood; Anxiety; Sleep; Productivity

Treatments: Other: Clevr Sleeptime; Other: Clevr Matcha; Other: Clevr Chai

Study type: Interventional

Funder types: Industry

Identifiers

NCT06146517

20341

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 28 to 42 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Clevr Blends Arm

Experimental group

Description:

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.

Treatment:

Other: Clevr Chai

Other: Clevr Matcha

Other: Clevr Sleeptime