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

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ClinicalTrials.gov Identifier: NCT05189275

Recruitment Status : Completed

First Posted : January 12, 2022

Last Update Posted : September 26, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Laura Stewart, University of Northern Colorado

Tracking Information

First Submitted Date ^ICMJE

November 20, 2021

First Posted Date ^ICMJE

January 12, 2022

Last Update Posted Date

September 26, 2023

Actual Study Start Date ^ICMJE

January 10, 2022

Actual Primary Completion Date

December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Change in Maximal Anaerobic Power [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
Wingate Power Test
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.
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
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
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
Change in a Stress Biomarker [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
Serum Cortisol
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)
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)
Change in Kidney Health Biomarker [ Time Frame: Just before the 8 Week Intervention and Immediately Following the 8 Week Intervention ]
Serum creatinine

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cannabidiol and Focus Study (CBD-Focus)

Official Title ^ICMJE

Cannabidiol and Focus Study (CBD-Focus)

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Dietary Supplement: Daily Beverage Intervention

Individuals will consume one of 4 beverages, daily for 8 weeks.

Study Arms ^ICMJE

Experimental: Cannabidiol 40 mg (CBD40)
Subjects consume beverages with 40mg of CBD.

Intervention: Dietary Supplement: Daily Beverage Intervention
Experimental: Cannabidiol 20 mg (CBD20)
Subjects consume beverages with 20mg of CBD.

Intervention: Dietary Supplement: Daily Beverage Intervention
Experimental: Cannabidiol 0 mg (CBD0)
Subjects consume beverages with 0mg of CBD.

Intervention: Dietary Supplement: Daily Beverage Intervention
Placebo Comparator: Placebo Beverage (PLAC)
Subjects consume calorie matched beverages with 0 CBD.

Intervention: Dietary Supplement: Daily Beverage Intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

December 31, 2022

Actual Primary Completion Date

December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05189275

Other Study ID Numbers ^ICMJE

28497

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

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.