An interventional study of Cannabidiol (CBD) in Healthy, sponsored by University of Northern Colorado. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by University of Northern Colorado · Not applicable, Interventional, and Basic science
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.
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
University of Northern Colorado is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Each group member will receive one dose of CBD daily for 8 weeks.
Dietary Supplement: Cannabidiol (CBD)
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).
Natural Killer Cell Number
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Time frame: 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.
Time frame: 8 Weeks
Physical Activity
We will use a Fitbit to track physical activity before and after the intervention.
Time frame: 8 Weeks
Sleep
We will use a Fitbit Sleep Tracker before and after the intervention.
Time frame: 8 Weeks
Immune Biomarker (C-Reactive Protein (CRP))
We will measure serum CRP in pre and post intervention samples.
Time frame: 8 Weeks
Immune Biomarker (Interleukin 6 (IL-6))
We will measure serum Il-6 in pre and post intervention samples.
Time frame: 8 Weeks
Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))
We will measure circulating BDNF in pre and post intervention samples.
Time frame: 8 Weeks
NK Cell Function
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Time frame: 8 Weeks
Body Composition
We will use the Bod Pod before and after the intervention to evaluate body composition.
Time frame: 8 Weeks
Anaerobic Fitness
We will test subject ability to perform a Wingate Power Test before and after the intervention.
Time frame: 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.
Time frame: 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.
Time frame: 8 Weeks
Sleep Evaluation Questionnaire
We will use the Leeds Sleep Evaluation Questionnaire before and after the intervention. Lower scores generally suggest better sleep.
Time frame: 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.
Time frame: 8 Weeks
Strength Assessment
All subjects will complete a 1 repetition or 8 repetition max back squat test before and after the intervention.
Time frame: 8 Weeks
Plan to share: Yes — All of the individual participant data collected during the trial, after de-identification will be available
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Northern Colorado