Clinical trial NCT05189275: Cannabidiol and Focus Study (CBD-Focus)
Official title: Cannabidiol and Focus Study (CBD-Focus)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cannabidiol
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Quality of Life Questionnaire Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Fatigue Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Sleep Assessment
timeFrame: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
measure: Change in Sleep Questionnaire Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Physical Activity (steps per day)
timeFrame: Just before the 8 Week Intervention and in the 7th Week of the 8 Week Intervention
measure: Change in Perceived Stress Scale Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in General Anxiety Disorder Questionnaire Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Psychological Wellbeing Scale Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Cognitive Function and Abilities Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change In Cognitive Function Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Athlete Sickness and Illness Assessment Score
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Sustained Attention to Response Task (SART) Activity
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Maximal Anaerobic Power
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Natural Killer (NK) Cell Number
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Natural Killer (NK) Cell Function
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in a Biomarker of Inflammation
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in a Biomarker of Neural Health
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in a Stress Biomarker
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Liver Health Biomarker I
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Liver Health Biomarker II
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
measure: Change in Kidney Health Biomarker
timeFrame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Greeley
country: United States
facility: University Of Northern Colorado
state: Colorado
Study officials:
affiliation: University of Northern Colorado
name: James Haughian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Northern Colorado
name: Laura K Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
References: