CBD, Immune Function, and Neural Health

NCT04881539 | Completed

• 1 other identifier: UNColorado
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

CBD

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• Body Composition

  8 Weeks

• Anaerobic Fitness

  8 Weeks

• Cognitive Function Questionnaire

  8 Weeks

• Anxiety Questionnaire

  8 Weeks

• Sleep Evaluation Questionnaire

  8 Weeks

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

Each group member will receive one dose of CBD daily for 8 weeks.

Dietary Supplement: Cannabidiol (CBD)

Placebo

PLACEBO COMPARATOR

Each group member will receive a calorie matched placebo daily for 8 weeks.

Dietary Supplement: Cannabidiol (CBD)

Interventions

Cannabidiol (CBD) DIETARY_SUPPLEMENT

This group will receive an oral dose of CBD (Six Degrees Wellness).

Cannabidiol (CBD); Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Individuals will be asked to self select their biological sex.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Northern Colorado: lead

Study Sites (1)

University Of Northern Colorado

Greeley, Colorado, 80639, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Laura Stewart, PhD

  University of Northern Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A person who does not interact with the study participants will be completing the masking.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study participants will be randomly assigned to either a CBD group or a placebo group and followed throughout the 8 week intervention period.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 11, 2021
• Study Start: May 15, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately after publication date for 3 years.
• Access Criteria: Proposals should be directed to laura.stewart@unco.edu

Locations

US (1)