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NCT Number: NCT04881539

CBD, Immune Function, and Neural Health

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Northern Colorado

Greeley, Colorado, 80639, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol (CBD)

Dietary Supplement

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

Primary outcomes

  1. Natural Killer Cell Number

    Time frame: 8 Weeks

    We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.

  2. Natural Killer Cell Number and Function

    Time frame: 8 Weeks

    We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.

  3. Physical Activity

    Time frame: 8 Weeks

    We will use a Fitbit to track physical activity before and after the intervention.

  4. Sleep

    Time frame: 8 Weeks

    We will use a Fitbit Sleep Tracker before and after the intervention.

  5. Immune Biomarker (C-Reactive Protein (CRP))

    Time frame: 8 Weeks

    We will measure serum CRP in pre and post intervention samples.

  6. Immune Biomarker (Interleukin 6 (IL-6))

    Time frame: 8 Weeks

    We will measure serum Il-6 in pre and post intervention samples.

  7. Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))

    Time frame: 8 Weeks

    We will measure circulating BDNF in pre and post intervention samples.

  8. NK Cell Function

    Time frame: 8 Weeks

    We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.

Secondary outcomes

  1. Body Composition

    Time frame: 8 Weeks

    We will use the Bod Pod before and after the intervention to evaluate body composition.

  2. Anaerobic Fitness

    Time frame: 8 Weeks

    We will test subject ability to perform a Wingate Power Test before and after the intervention.

  3. Cognitive Function Questionnaire

    Time frame: 8 Weeks

    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.

  4. Anxiety Questionnaire

    Time frame: 8 Weeks

    We will use the General Anxiety Disorder -7 Questionnaire before and after the intervention. The higher the score suggests higher levels of anxiety.

  5. Sleep Evaluation Questionnaire

    Time frame: 8 Weeks

    We will use the Leeds Sleep Evaluation Questionnaire before and after the intervention. Lower scores generally suggest better sleep.

  6. Depression Questionnaire

    Time frame: 8 Weeks

    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.

  7. Strength Assessment

    Time frame: 8 Weeks

    All subjects will complete a 1 repetition or 8 repetition max back squat test before and after the intervention.

Sponsors and collaborators

Lead sponsor

University of Northern Colorado

Other

Registry information

Official study title

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?

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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