HealthyNCT04881539
CBD, Immune Function, and Neural Health
A study testing Cannabidiol (CBD) in people with Healthy, run by University of Northern Colorado at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 18 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Northern Colorado
Greeley, Colorado, 80639
About this study
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?
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.
Read the 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
- Being tested
- Cannabidiol (CBD)
- Keywords
- CBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Dietary supplement
This group will receive an oral dose of CBD (Six Degrees Wellness).
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Each group member will receive one dose of CBD daily for 8 weeks. Receives: Dietary Supplement: Cannabidiol (CBD) |
| Placebo | Placebo comparator | Each group member will receive a calorie matched placebo daily for 8 weeks. Receives: Dietary Supplement: Cannabidiol (CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural Killer Cell Number
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Measured: 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.
Measured: 8 Weeks
Physical Activity
We will use a Fitbit to track physical activity before and after the intervention.
Measured: 8 Weeks
Sleep
We will use a Fitbit Sleep Tracker before and after the intervention.
Measured: 8 Weeks
Immune Biomarker (C-Reactive Protein (CRP))
We will measure serum CRP in pre and post intervention samples.
Measured: 8 Weeks
Immune Biomarker (Interleukin 6 (IL-6))
We will measure serum Il-6 in pre and post intervention samples.
Measured: 8 Weeks
Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))
We will measure circulating BDNF in pre and post intervention samples.
Measured: 8 Weeks
NK Cell Function
We will use a flow cytometry to evaluate natural killer cell number and function before and after the intervention.
Measured: 8 Weeks
Secondary outcomes (7)
Body Composition
We will use the Bod Pod before and after the intervention to evaluate body composition.
Measured: 8 Weeks
Anaerobic Fitness
We will test subject ability to perform a Wingate Power Test before and after the intervention.
Measured: 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.
Measured: 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.
Measured: 8 Weeks
Sleep Evaluation Questionnaire
We will use the Leeds Sleep Evaluation Questionnaire before and after the intervention. Lower scores generally suggest better sleep.
Measured: 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.
Measured: 8 Weeks
Strength Assessment
All subjects will complete a 1 repetition or 8 repetition max back squat test before and after the intervention.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start15 May 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, University of Northern Colorado
- Investigators
- Laura Stewart, PhD, Principal investigator, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881539
- Sponsor's protocol ID
- UNColorado
- Status last verified
- Mar 2022
- First submitted
- 21 Apr 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification will be available
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT04881539
- Acronym / sponsor ID
- UNColorado
- Conditions
- Healthy
- Keywords
- CBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Dietary Supplement: Cannabidiol (CBD)Each group member will receive one dose of CBD daily for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Cannabidiol (CBD)Each group member will receive a calorie matched placebo daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)This group will receive an oral dose of CBD (Six Degrees Wellness). | Dietary supplement | Cannabidiol (CBD), Placebo |
Primary outcome
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.
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.
Physical Activity
Time frame: 8 Weeks
We will use a Fitbit to track physical activity before and after the intervention.
Sleep
Time frame: 8 Weeks
We will use a Fitbit Sleep Tracker before and after the intervention.
Immune Biomarker (C-Reactive Protein (CRP))
Time frame: 8 Weeks
We will measure serum CRP in pre and post intervention samples.
Immune Biomarker (Interleukin 6 (IL-6))
Time frame: 8 Weeks
We will measure serum Il-6 in pre and post intervention samples.
Neural Health Biomarker (Brain Derived Neurotrophic Factor (BDNF))
Time frame: 8 Weeks
We will measure circulating BDNF in pre and post intervention samples.
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.
7 secondary outcomes
Body Composition
Time frame: 8 Weeks
Anaerobic Fitness
Time frame: 8 Weeks
Cognitive Function Questionnaire
Time frame: 8 Weeks
Anxiety Questionnaire
Time frame: 8 Weeks
Sleep Evaluation Questionnaire
Time frame: 8 Weeks
Depression Questionnaire
Time frame: 8 Weeks
Strength Assessment
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Stewart, PhD principal investigator
University of Northern Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol (CBD) in people with Healthy, run by University of Northern Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural Killer Cell Number (time frame: 8 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.