CBD, Immune Function, and Neural Health

Study Overview
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Brief Summary
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Chronic inflammation, which is defined as a persistent, low-grade inflammatory response within the body, is associated with many of the negative health conditions which are prevalent in our society today. It is most well-known for its role in the progression of diseases including obesity, metabolic syndrome, cancer, cardiovascular disease, and diabetes. Chronic inflammation is also linked to many of the underlying factors associated with disease development including perturbations in sleep, and mental health status such as depression, anxiety, fatigue, and quality of life. Natural killer cells, commonly referred to as NK cells, are a subset of white blood cells that play an important role in the coordination of inflammation in the body. Although many interventions aimed at controlling chronic inflammation and enhancing NK cell number and activity have been explored, relatively few have been administered without significant barriers. Cannabidiol (CBD), a non-psychoactive hemp derivative, is a potential, attractive therapeutic target. However, there is very little information in humans that addresses the potential of CBD to improve your health and immune function. The overall goal of this study is to explore the effects of 8-weeks of CBD supplementation on mental and physical health, sleep measures, and NK cell number and cytotoxic function. Specific Aim 1. Explore the effect of 8-weeks of CBD administration on sleep measures as well as measures of mental and physical health in conjunction with measurements of NK cell number and function.

Detailed Description
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In this double-blind investigation, participants will undergo 8 total visits separated by an 8-week intervention period. One week prior to the intervention period, participants will complete a blood draw, body composition analysis, aerobic and anaerobic fitness analysis, maximal strength testing, and physical activity and sleep quantity and quality analyses. These tests will be completed again following the 8-week intervention period. Following the first 4 visits, participants will be randomly assigned 1 of 2 groups: CBD (50mg/day) or calorie matched placebo. Participants will then complete the 8-week intervention period. Additionally, during week 4 of the 8-week intervention period (intervention midpoint), participants will complete a blood draw, one full week of physical activity and sleep actigraphy, surveys on mental health and wellbeing, and prevalence of sickness and illness

Official Title
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Are Natural Killer Cells Novel Mediators of the Effects of Cannabidiol on Physical Fitness, Mental Health and Well-Being, Sleep Quantity, Sleep Quantity and Immune Function?

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Cannabidiol (CBD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be within 18 and 50 years of age Abstained from cannabis (either THC and/or CBD) for the past 6 weeks Have a BMI of 29.9 or below Completes at least 150 minutes of moderate to vigorous physical activity per week. Able and willing to commit to an 8-week intervention schedule Exclusion Criteria: Significant cardiovascular disorders including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, stroke, or transient ischemic attacks, peripheral vascular disease with intermittent claudication, acute, chronic or recurrent thrombophlebitis. Diagnosed neurological disorders including but not limited to brain tumors, brain injuries, Alzheimer's Disease, Parkinson's Disease, multiple sclerosis, epilepsy, and seizures. Regular use of drugs that significantly alter brain activity such as selective serotonin reuptake inhibitors, benzodiazepines, and others used to treat anxiety, panic, stress, sleep disorders, or increases the risk of sedation and drowsiness. Head trauma with loss of consciousness for more than 30 mins.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants will be randomly assigned to either a CBD group or a placebo group and followed throughout the 8 week intervention period.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol (CBD)<br>Each group member will receive one dose of CBD daily for 8 weeks. | Dietary Supplement: Cannabidiol (CBD)<br>* This group will receive an oral dose of CBD (Six Degrees Wellness).<br>|
| Placebo Comparator: Placebo<br>Each group member will receive a calorie matched placebo daily for 8 weeks. | Dietary Supplement: Cannabidiol (CBD)<br>* This group will receive an oral dose of CBD (Six Degrees Wellness).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural Killer Cell Number | We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention. | 8 Weeks | 
| Natural Killer Cell Number and Function | We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention. | 8 Weeks | 
| Physical Activity | We will use a Fitbit to track physical activity before and after the intervention. | 8 Weeks | 
| Sleep | We will use a Fitbit Sleep Tracker before and after the intervention. | 8 Weeks | 
| Immune Biomarker (C-Reactive Protein (CRP)) | We will measure serum CRP in pre and post intervention samples. | 8 Weeks | 
| Immune Biomarker (Interleukin 6 (IL-6)) | We will measure serum Il-6 in pre and post intervention samples. | 8 Weeks | 
| Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF)) | We will measure circulating BDNF in pre and post intervention samples. | 8 Weeks | 
| NK Cell Function | We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | We will use the Bod Pod before and after the intervention to evaluate body composition. | 8 Weeks | 
| Anaerobic Fitness | We will test subject ability to perform a Wingate Power Test before and after the intervention. | 8 Weeks | 
| Cognitive Function Questionnaire | We will evaluate cognitive function with the PROMIS SF v. 2.0 Abilities Questionnaire before and after the intervention. A higher score suggests higher cognitive ability. | 8 Weeks | 
| Anxiety Questionnaire | We will use the General Anxiety Disorder -7 Questionnaire before and after the intervention. The higher the score suggests higher levels of anxiety. | 8 Weeks | 
| Sleep Evaluation Questionnaire | We will use the Leeds Sleep Evaluation Questionnaire before and after the intervention. Lower scores generally suggest better sleep. | 8 Weeks | 
| Depression Questionnaire | We will use the Beck Depression Inventory before and after the intervention period. A higher score on this survey suggests the presence of more depression. | 8 Weeks | 
| Strength Assessment | All subjects will complete a 1 repetition or 8 repetition max back squat test before and after the intervention. | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBD