CBD, Immune Function, and Neural Health

NCT ID: NCT04881539

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-03-18

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cannabidiol (CBD)

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

Group Type: EXPERIMENTAL

Cannabidiol (CBD)

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Cannabidiol (CBD)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cannabidiol (CBD)

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Northern Colorado

OTHER

Sponsor Role: lead

Responsible Party

Laura Stewart

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Stewart, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Northern Colorado

Locations

University Of Northern Colorado

Greeley, Colorado, United States

Countries

United States

Other Identifiers

UNColorado

Identifier Type: -

Identifier Source: org_study_id