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Cannabidiol and Focus Study (CBD-Focus) (CBD-Focus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189275
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Laura Stewart, University of Northern Colorado

Brief Summary:
Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. Natural killers cells (NKC) play a vital role in maintain your body's defenses and are an essential component of your immune system. In humans, NKC contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Daily Beverage Intervention Not Applicable

Detailed Description:

BACKGROUND: Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. In humans, natural killer cells (NKC) contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.

METHODS: In this double-blind, placebo-controlled, 4 arm clinical trial, male and female participants will undergo 2 pre intervention study visits and 3 post intervention study visits separated by an 8-week intervention period. Participants must be aged 18-50 years old, currently completing at least 150 minutes of moderate to vigorous physical activity per week, have a body mass index under 29.9, with no significant physical or mental health (without the presence of chronic depression or anxiety) conditions. Subjects may not have an allergy to soy. All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks. Supplementation groups will be randomly assigned into groups consuming one of 4 beverages: 1) a beverage with 40 mg of CBD (CBD40, n=50), 2) a beverage with 20 mg of CBD (CBD20, n=50), 3) a beverage with 0 mg of CBD (CBD0, n=50) or 4) calorie-matched placebo (PLAC, n=50).

INTERVENTION DESCRIPTION: Participants will be instructed to consume one beverage per day following their last meal, 1-1.5h before bed. Four weeks of beverages will be provided at a time. These beverage deposits will include an in person check in at the midpoint of the study. Participants and researchers will be blinded to the intervention groups. All participants will be given a 4-week supply of beverages. Investigators will meet with participants weekly via zoom/phone call and to report any adverse side effects or changes in physical activity routine. All products will be provided by Ocean Spray. All products are hemp derived, within legal limits and have had their purity verified. Following the completion of data collection for all study participants, researchers will be unblinded to supplementation groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Cannabidiol and Focus Study (CBD-Focus)
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Cannabidiol 40 mg (CBD40)
Subjects consume beverages with 40mg of CBD.
Dietary Supplement: Daily Beverage Intervention
Individuals will consume one of 4 beverages, daily for 8 weeks.

Experimental: Cannabidiol 20 mg (CBD20)
Subjects consume beverages with 20mg of CBD.
Dietary Supplement: Daily Beverage Intervention
Individuals will consume one of 4 beverages, daily for 8 weeks.

Experimental: Cannabidiol 0 mg (CBD0)
Subjects consume beverages with 0mg of CBD.
Dietary Supplement: Daily Beverage Intervention
Individuals will consume one of 4 beverages, daily for 8 weeks.

Placebo Comparator: Placebo Beverage (PLAC)
Subjects consume calorie matched beverages with 0 CBD.
Dietary Supplement: Daily Beverage Intervention
Individuals will consume one of 4 beverages, daily for 8 weeks.




Primary Outcome Measures :
  1. Change in Quality of Life Questionnaire Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Ferrans and Powers Quality of Life Index Questionnaire. A higher scores suggests higher quality of life.

  2. Change in Fatigue Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Piper Fatigue Questionnaire. A higher score suggests higher levels of fatigue.

  3. Change in Sleep Assessment [ Time Frame: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention ]
    Sleep Assessment (7 day). We will use Fitbits to track sleep.

  4. Change in Sleep Questionnaire Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Leeds Sleep Questionnaire. Lower scores generally suggest better sleep.

  5. Change in Physical Activity (steps per day) [ Time Frame: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention ]
    Physical Activity Assessment (7 day). We will use Fitbits to track physical activity.

  6. Change in Perceived Stress Scale Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Perceived Stress Questionnaire. A higher score suggests higher perceived stress.

  7. Change in General Anxiety Disorder Questionnaire Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    General Anxiety Disorder Questionnaire 7. A higher score suggests higher levels of anxiety.

  8. Change in Psychological Wellbeing Scale Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Psychological Wellbeing Questionnaire. A higher score suggests better wellbeing.

  9. Change in Cognitive Function and Abilities Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities - Short Form 8a. A higher score suggests higher cognitive ability.

  10. Change In Cognitive Function Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    PROMIS Cognitive Function - Short Form 8a. A higher score suggests higher cognitive ability.

  11. Change in Athlete Sickness and Illness Assessment Score [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    The Wisconsin Upper Respiratory Symptom Survey. A higher scores suggests more respiratory symptoms.

  12. Change in Sustained Attention to Response Task (SART) Activity [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Sustained Attention to Response Task (SART) Activity

  13. Change in Maximal Anaerobic Power [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Wingate Power Test

  14. Change in Natural Killer (NK) Cell Number [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    NK Cell Counts obtained on a flow cytometer.

  15. Change in Natural Killer (NK) Cell Function [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    NK Cell Cellular Function Assay using Flow Cytometry

  16. Change in a Biomarker of Inflammation [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Serum C-Reactive Protein

  17. Change in a Biomarker of Neural Health [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Circulating Brain Derived Neurotropic Factor

  18. Change in a Stress Biomarker [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Serum Cortisol

  19. Change in Liver Health Biomarker I [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Serum Aspartate aminotransferase (AST)

  20. Change in Liver Health Biomarker II [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Serum Alanine aminotransferase (ALT)

  21. Change in Kidney Health Biomarker [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
    Serum creatinine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently completing at least 150 minutes of moderate to vigorous physical activity per week
  • Have a body mass index under 29.9
  • No significant physical or mental health (without the presence of chronic depression or anxiety) conditions
  • No presence or past diagnosis of eating disorders

Exclusion Criteria:

  • Subjects may not have an allergy to soy.
  • All study subjects must also be free of cannabis product use or regular high doses of antioxidants for the previous 8 weeks.

Participants receive a $200 Visa Gift Card after the last study visit is completed.


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): NCT05189275


Contacts
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Contact: Laura K Stewart, PhD 970-413-3119 laura.stewart@unco.edu

Locations
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United States, Colorado
University Of Northern Colorado Recruiting
Greeley, Colorado, United States, 80639
Contact: Laura K Stewart, PhD    970-351-1891    laura.stewart@unco.edu   
Sponsors and Collaborators
University of Northern Colorado
Investigators
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Principal Investigator: James Haughian, PhD University of Northern Colorado
Principal Investigator: Laura K Stewart, PhD University of Northern Colorado
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Responsible Party: Laura Stewart, Professor, University of Northern Colorado
ClinicalTrials.gov Identifier: NCT05189275    
Other Study ID Numbers: 28497
First Posted: January 12, 2022    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: Data will become available when the study is published and will be available for 3 years.
Supporting Materials: Study Protocol
Time Frame: Data will become available when the study is published and will be available for 3 years.
Access Criteria: Data (without subject ID numbers) will be shared upon email request 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:
Cannabidiol