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

Not Applicable

Completed

• Conditions: Sleep; Fear; Low Mood; Stress; Anxiety
• Interventions: Dietary Supplement: The Daily Supplement

• Registration Number: NCT05518019
• Lead Sponsor: Prima CBD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-14
• Primary Completion: 2022-06-29
• Study Completion: 2022-06-29
• Status Verified: 2022-08
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prima CBD "The Daily" Supplement	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

Primary Outcome Measures

Name	Time	Method
Change in mood as measured by questionnaire	2 months	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 stress and anxiety as measured by questionnaires.	2 months	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

Name	Time	Method
Change in sleep quality and quantity as measured by digital wearable devices and by self-report	2 months	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States