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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Sleep; Anxiety; Fear; Low Mood
• Intervention / Treatment: Dietary supplement: The Daily Supplement

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Prima CBD "The Daily" Supplement; 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

Dietary supplement: The Daily Supplement; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	2 months
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")	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in overall well-being as measured by self-report and questionnaires.	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")	2 months

Collaborators and Investigators

• Sponsor: Prima CBD
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2022
• Primary Completion (ACTUAL): June 29, 2022
• Study Completion (ACTUAL): June 29, 2022

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (ACTUAL): August 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Sleep; Fear; Focus; Calmness; Low Mood
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No