CBD, Immune Function, and Neural Health

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?

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Cannabidiol (CBD)

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Greeley, Colorado, United States, 80639
      • University of Northern Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Northern Colorado
• Investigators: Principal Investigator: Laura Stewart, PhD, University of Northern Colorado

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: CBD
• Additional Relevant MeSH Terms: Anticonvulsants; Cannabidiol
• Other Study ID Numbers: UNColorado

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification will be available
• IPD Sharing Time Frame: Immediately after publication date for 3 years.
• IPD Sharing Access Criteria: Proposals should be directed to laura.stewart@unco.edu
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No