CBD, Immune Function, and Neural Health

University of Northern Colorado50 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Natural Killer Cell Number

We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.

Time frame: 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.

Time frame: 8 Weeks

Physical Activity

We will use a Fitbit to track physical activity before and after the intervention.

Time frame: 8 Weeks

Sleep

We will use a Fitbit Sleep Tracker before and after the intervention.

Time frame: 8 Weeks

Immune Biomarker (C-Reactive Protein (CRP))

We will measure serum CRP in pre and post intervention samples.

Time frame: 8 Weeks

Immune Biomarker (Interleukin 6 (IL-6))

We will measure serum Il-6 in pre and post intervention samples.

Time frame: 8 Weeks

Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))

We will measure circulating BDNF in pre and post intervention samples.

Time frame: 8 Weeks

NK Cell Function

We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.

Time frame: 8 Weeks

Secondary Outcomes

Body Composition

We will use the Bod Pod before and after the intervention to evaluate body composition.

Time frame: 8 Weeks

Anaerobic Fitness

We will test subject ability to perform a Wingate Power Test before and after the intervention.

Time frame: 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.

Time frame: 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.

Time frame: 8 Weeks

Sleep Evaluation Questionnaire

We will use the Leeds Sleep Evaluation Questionnaire before and after the intervention. Lower scores generally suggest better sleep.

Time frame: 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.

Time frame: 8 Weeks

Strength Assessment

All subjects will complete a 1 repetition or 8 repetition max back squat test before and after the intervention.

Time frame: 8 Weeks

CBD, Immune Function, and Neural Health

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes