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

NCT ID: NCT05518019

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2022-06-29

Brief Summary

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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

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Conditions

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Anxiety Fear Stress Low Mood Sleep

Keywords

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Anxiety Fear Stress Low Mood Sleep Focus Calmness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

The Daily Supplement

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

Prima CBD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne Mitschke

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20236

Identifier Type: -

Identifier Source: org_study_id