Cannabidiol and Focus Study (CBD-Focus)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cannabidiol and Focus Study (CBD-Focus)

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Daily Beverage Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol 40 mg (CBD40)<br>Subjects consume beverages with 40mg of CBD. | Dietary Supplement: Daily Beverage Intervention<br>* Individuals will consume one of 4 beverages, daily for 8 weeks.<br>|
| Experimental: Cannabidiol 20 mg (CBD20)<br>Subjects consume beverages with 20mg of CBD. | Dietary Supplement: Daily Beverage Intervention<br>* Individuals will consume one of 4 beverages, daily for 8 weeks.<br>|
| Experimental: Cannabidiol 0 mg (CBD0)<br>Subjects consume beverages with 0mg of CBD. | Dietary Supplement: Daily Beverage Intervention<br>* Individuals will consume one of 4 beverages, daily for 8 weeks.<br>|
| Placebo Comparator: Placebo Beverage (PLAC)<br>Subjects consume calorie matched beverages with 0 CBD. | Dietary Supplement: Daily Beverage Intervention<br>* Individuals will consume one of 4 beverages, daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Questionnaire Score | Ferrans and Powers Quality of Life Index Questionnaire. A higher scores suggests higher quality of life. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Fatigue Score | Piper Fatigue Questionnaire. A higher score suggests higher levels of fatigue. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Sleep Assessment | Sleep Assessment (7 day). We will use Fitbits to track sleep. | Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention | 
| Change in Sleep Questionnaire Score | Leeds Sleep Questionnaire. Lower scores generally suggest better sleep. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Physical Activity (steps per day) | Physical Activity Assessment (7 day). We will use Fitbits to track physical activity. | Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention | 
| Change in Perceived Stress Scale Score | Perceived Stress Questionnaire. A higher score suggests higher perceived stress. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in General Anxiety Disorder Questionnaire Score | General Anxiety Disorder Questionnaire 7. A higher score suggests higher levels of anxiety. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Psychological Wellbeing Scale Score | Psychological Wellbeing Questionnaire. A higher score suggests better wellbeing. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Cognitive Function and Abilities Score | Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Abilities - Short Form 8a. A higher score suggests higher cognitive ability. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change In Cognitive Function Score | PROMIS Cognitive Function - Short Form 8a. A higher score suggests higher cognitive ability. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Athlete Sickness and Illness Assessment Score | The Wisconsin Upper Respiratory Symptom Survey. A higher scores suggests more respiratory symptoms. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Sustained Attention to Response Task (SART) Activity | Sustained Attention to Response Task (SART) Activity | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Maximal Anaerobic Power | Wingate Power Test | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Natural Killer (NK) Cell Number | NK Cell Counts obtained on a flow cytometer. | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Natural Killer (NK) Cell Function | NK Cell Cellular Function Assay using Flow Cytometry | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in a Biomarker of Inflammation | Serum C-Reactive Protein | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in a Biomarker of Neural Health | Circulating Brain Derived Neurotropic Factor | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in a Stress Biomarker | Serum Cortisol | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Liver Health Biomarker I | Serum Aspartate aminotransferase (AST) | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Liver Health Biomarker II | Serum Alanine aminotransferase (ALT) | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 
| Change in Kidney Health Biomarker | Serum creatinine | Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol