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Completed

NCT Number: NCT05189275

Cannabidiol and Focus Study (CBD-Focus)

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Northern Colorado

Greeley, Colorado, 80639, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily Beverage Intervention

Dietary Supplement

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Northern Colorado

Other

Registry information

Acronym: CBD-Focus

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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