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An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus

Primary Purpose

Anxiety, Fear, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Daily Supplement
Sponsored by
Prima CBD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring Anxiety, Fear, Stress, Low Mood, Sleep, Focus, Calmness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day).
  • Must be in general good health (e.g., no long term health issues that would impact your participation.
  • Moderate self-reported issues with stress, mood, focus, and sleep.

Exclusion Criteria:

  • Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days.
  • Currently receiving other psychotherapeutic treatment for anxiety or depression.
  • Diagnosed anxiety or depression
  • BMI over 40
  • Known allergic reactions that would require the use of an epi-pen
  • Females who are pregnant or breastfeeding.

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prima CBD "The Daily" Supplement

Arm Description

Participants are provided with the dietary supplement (1 capsule per day). Participants are to take the supplement at the same time every day Participants will take a weekly well-being survey Participants are to complete the well-being questionnaire after the 4th week

Outcomes

Primary Outcome Measures

Change in stress and anxiety as measured by questionnaires.
Feeling states that will be measured include stress, calmness, balance, relaxation, and focus Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")
Change in mood as measured by questionnaire
Feeling states that will be measured include stress, calmness, balance, relaxation, and focus Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")

Secondary Outcome Measures

Change in sleep quality and quantity as measured by digital wearable devices and by self-report
Sleep will be measured two ways. Questionnaires will be used to assess sleep quality and quantity. Participants will also use wearable devices to track their sleep over the course of the study.

Full Information

First Posted
August 24, 2022
Last Updated
August 26, 2022
Sponsor
Prima CBD
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT05518019
Brief Title
An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus
Official Title
An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
June 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prima CBD
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fear, Stress, Low Mood, Sleep
Keywords
Anxiety, Fear, Stress, Low Mood, Sleep, Focus, Calmness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prima CBD "The Daily" Supplement
Arm Type
Experimental
Arm Description
Participants are provided with the dietary supplement (1 capsule per day). Participants are to take the supplement at the same time every day Participants will take a weekly well-being survey Participants are to complete the well-being questionnaire after the 4th week
Intervention Type
Dietary Supplement
Intervention Name(s)
The Daily Supplement
Intervention Description
Each serving of the dietary supplement (defined as 1 softgel) contains the following formulation: Organic Broad Spectrum Hemp Extract 35mg Bio-Terpene Complex 52mg Palm Monoglycerides Organic Hemp Seed Oil, Clove Bud Oil, Black Pepper Berry Essential Oil Curcumin (Turmeric Root) Essential Oil Inactive ingredients: Organic Flaxseed Oil, Gel Shell (Modified Tapioca Starch, Glycerin, Purified Water, Maltitol
Primary Outcome Measure Information:
Title
Change in stress and anxiety as measured by questionnaires.
Description
Feeling states that will be measured include stress, calmness, balance, relaxation, and focus Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")
Time Frame
2 months
Title
Change in mood as measured by questionnaire
Description
Feeling states that will be measured include stress, calmness, balance, relaxation, and focus Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in sleep quality and quantity as measured by digital wearable devices and by self-report
Description
Sleep will be measured two ways. Questionnaires will be used to assess sleep quality and quantity. Participants will also use wearable devices to track their sleep over the course of the study.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Change in overall well-being as measured by self-report and questionnaires.
Description
Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day). Must be in general good health (e.g., no long term health issues that would impact your participation. Moderate self-reported issues with stress, mood, focus, and sleep. Exclusion Criteria: Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days. Currently receiving other psychotherapeutic treatment for anxiety or depression. Diagnosed anxiety or depression BMI over 40 Known allergic reactions that would require the use of an epi-pen Females who are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Mitschke
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus

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