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CBD, Immune Function, and Neural Health

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ClinicalTrials.gov Identifier: NCT04881539
Recruitment Status : Completed
First Posted : May 11, 2021
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Laura Stewart, University of Northern Colorado

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Cannabidiol (CBD) Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be randomly assigned to either a CBD group or a placebo group and followed throughout the 8 week intervention period.
Masking: Double (Participant, Investigator)
Masking Description: A person who does not interact with the study participants will be completing the masking.
Primary Purpose: Basic Science
Official 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?
Actual Study Start Date : May 15, 2021
Actual Primary Completion Date : March 18, 2022
Actual Study Completion Date : March 18, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabidiol (CBD)
Each group member will receive one dose of CBD daily for 8 weeks.
 Dietary Supplement: Cannabidiol (CBD)
This group will receive an oral dose of CBD (Six Degrees Wellness).
Placebo Comparator: Placebo
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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Individuals will be asked to self select their biological sex.
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881539


Locations
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United States, Colorado
University Of Northern Colorado
Greeley, Colorado, United States, 80639
Sponsors and Collaborators
University of Northern Colorado
Investigators
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Principal Investigator: Laura Stewart, PhD University of Northern Colorado
More Information
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Responsible Party: Laura Stewart, Professor, University of Northern Colorado
ClinicalTrials.gov Identifier: NCT04881539    
Other Study ID Numbers: UNColorado
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after de-identification will be available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Immediately after publication date for 3 years.
Access Criteria: Proposals should be directed to laura.stewart@unco.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Stewart, University of Northern Colorado:
CBD
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants