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

NCT ID: NCT06146517

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-01-22

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.

Detailed Description

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Conditions

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Sleep Mood Caffeine Withdrawal Anxiety Productivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clevr Sleeptime

Intervention Type OTHER

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

Clevr Matcha

Intervention Type OTHER

Participants will trial Clevr Matcha during weeks 5-8.

Clevr Chai

Intervention Type OTHER

Participants will trial Clevr Chai during weeks 9-12.

Interventions

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Clevr Sleeptime

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

Intervention Type OTHER

Clevr Matcha

Participants will trial Clevr Matcha during weeks 5-8.

Intervention Type OTHER

Clevr Chai

Participants will trial Clevr Chai during weeks 9-12.

Intervention Type OTHER

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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

Clevr Blends

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20341

Identifier Type: -

Identifier Source: org_study_id

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