Cannabidiol and Focus Study (CBD-Focus)

NCT05189275 | Completed

• 1 other identifier: 28497
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (4)

Cannabidiol 40 mg (CBD40)

EXPERIMENTAL

Subjects consume beverages with 40mg of CBD.

Dietary Supplement: Daily Beverage Intervention

Cannabidiol 20 mg (CBD20)

EXPERIMENTAL

Subjects consume beverages with 20mg of CBD.

Dietary Supplement: Daily Beverage Intervention

Cannabidiol 0 mg (CBD0)

EXPERIMENTAL

Subjects consume beverages with 0mg of CBD.

Dietary Supplement: Daily Beverage Intervention

Placebo Beverage (PLAC)

PLACEBO COMPARATOR

Subjects consume calorie matched beverages with 0 CBD.

Dietary Supplement: Daily Beverage Intervention

Interventions

Daily Beverage Intervention DIETARY_SUPPLEMENT

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

Cannabidiol 0 mg (CBD0); Cannabidiol 20 mg (CBD20); Cannabidiol 40 mg (CBD40); Placebo Beverage (PLAC)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Northern Colorado: lead

Study Sites (1)

University Of Northern Colorado

Greeley, Colorado, 80639, United States

Location

Study Officials

• James Haughian, PhD

  University of Northern Colorado

  PRINCIPAL INVESTIGATOR

• Laura K Stewart, PhD

  University of Northern Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: January 12, 2022
• Study Start: January 10, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)