Anxiety, Fear, Low Mood, Sleep, Stress
Conditions
Keywords
Anxiety, Fear, Stress, Low Mood, Sleep, Focus, Calmness
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.
Interventions
DIETARY_SUPPLEMENTThe 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
Sponsors
Citruslabs
Prima CBD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stress and anxiety as measured by questionnaires. | 2 months | 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) |
| Change in mood as measured by questionnaire | 2 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality and quantity as measured by digital wearable devices and by self-report | 2 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in overall well-being as measured by self-report and questionnaires. | 2 months | 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) |
Countries
United States
Outcome results
None listed