Clinical trial NCT04881539: CBD, Immune Function, and Neural Health
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: CBD
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Natural Killer Cell Number
timeFrame: 8 Weeks
measure: Natural Killer Cell Number and Function
timeFrame: 8 Weeks
measure: Physical Activity
timeFrame: 8 Weeks
measure: Sleep
timeFrame: 8 Weeks
measure: Immune Biomarker (C-Reactive Protein (CRP))
timeFrame: 8 Weeks
measure: Immune Biomarker (Interleukin 6 (IL-6))
timeFrame: 8 Weeks
measure: Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))
timeFrame: 8 Weeks
measure: NK Cell Function
timeFrame: 8 Weeks
Secondary outcomes:
measure: Body Composition
timeFrame: 8 Weeks
measure: Anaerobic Fitness
timeFrame: 8 Weeks
measure: Cognitive Function Questionnaire
timeFrame: 8 Weeks
measure: Anxiety Questionnaire
timeFrame: 8 Weeks
measure: Sleep Evaluation Questionnaire
timeFrame: 8 Weeks
measure: Depression Questionnaire
timeFrame: 8 Weeks
measure: Strength Assessment
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Greeley
country: United States
facility: University Of Northern Colorado
state: Colorado
Study officials:
affiliation: University of Northern Colorado
name: Laura Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
References: