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

• ClinicalTrials.gov Identifier: NCT05189275
• Recruitment Status: Completed
• First Posted: January 12, 2022
• Last Update Posted: September 26, 2023
• Sponsor: University of Northern Colorado
• Information provided by (Responsible Party): Laura Stewart, University of Northern Colorado

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: December 31, 2022
• Actual Study Completion Date: December 31, 2022

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Colorado

University Of Northern Colorado

Greeley, Colorado, United States, 80639

Sponsors and Collaborators

University of Northern Colorado

Investigators

• Principal Investigator: James Haughian, PhD; University of Northern Colorado
• Principal Investigator: Laura K Stewart, PhD; University of Northern Colorado

More Information

• Responsible Party: Laura Stewart, Professor, University of Northern Colorado
• ClinicalTrials.gov Identifier: NCT05189275
• Other Study ID Numbers: 28497
• First Posted: January 12, 2022
• Last Update Posted: September 26, 2023
• Last Verified: September 2023

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.

• 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