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

NCT05518019 | Completed

• 1 other identifier: 20236
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Fear; Stress; Low Mood; Sleep

Keywords

Anxiety; Fear; Stress; Low Mood; Sleep; Focus; Calmness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in sleep quality and quantity as measured by digital wearable devices and by self-report

  2 months

Other Outcomes (1)

• Change in overall well-being as measured by self-report and questionnaires.

  2 months

Study Arms (1)

Prima CBD "The Daily" Supplement

EXPERIMENTAL

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

Interventions

The Daily Supplement DIETARY_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

Prima CBD "The Daily" Supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prima CBD: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Consciousness Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Susanne Mitschke

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: February 14, 2022
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (1)