NCT04881539

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Northern Colorado · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cannabidiol (CBD)	This group will receive an oral dose of CBD (Six Degrees Wellness).

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2021-05-11
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States