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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518019
• Other study ID #: 20236
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: June 29, 2022

Study information

• Verified date: August 2022
• Source: Prima CBD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 29, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Fear
• Low Mood
• Sleep
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Prima CBD	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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