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

Study Overview
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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.

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

Conditions
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Anxiety, Fear, Stress, Low Mood, Sleep

Intervention / Treatment
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* Dietary Supplement: The Daily Supplement


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prima CBD The Daily Supplement<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Anxiety, Fear, Low Mood, Sleep, Focus, Calmness