Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |