Assessing the Effects of a Cannabidiol Derived From Hemp Supplement in Healthy Adults

NCT05212402 | Completed DMC

• 1 other identifier: Pro00115662
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, randomized, double-blind, placebo-controlled trial is to assess the physiological, biochemical, and psychometric impacts of a brand-specific hemp-derived cannabidiol product in a sample of healthy adults.

Conditions

Healthy; Safety Issues

Outcome Measures

Primary Outcomes (30)

• Changes in angiotensin-renin converting enzyme (ACE)

  To determine if the test product (TP) has any effect on the activity of angiotensin-renin converting enzyme (ACE) compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in white blood cell count

  To determine if the TP has an impact on white blood cell count compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in red blood cell count

  To determine if the TP has an impact on red blood cell count compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in hemoglobin

  To determine if the TP has an impact on hemoglobin compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in hematocrit

  To determine if the TP has an impact on hematocrit compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in mean corpuscular volume

  To determine if the TP has an impact on mean corpuscular volume compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in mean corpuscular hemoglobin concentration

  To determine if the TP has an impact on mean corpuscular hemoglobin concentration compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in red blood cell distribution width

  To determine if the TP has an impact on red blood cell distribution width concentration compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in platelet count

  To determine if the TP has an impact on platelet count compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in mean platelet volume

  To determine if the TP has an impact on mean platelet volume compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in absolute and relative neutrophils

  To determine if the TP has an impact on absolute and relative neutrophils compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in absolute and relative lymphocytes

  To determine if the TP has an impact on absolute and relative lymphocytes compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in absolute and relative monocytes

  To determine if the TP has an impact on absolute and relative monocytes compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in absolute and relative eosinophils

  To determine if the TP has an impact on absolute and relative eosinophils compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in absolute and relative basophils

  To determine if the TP has an impact on absolute and relative basophils compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in TNF-alpha

  To determine if the TP has an impact on TNF-alpha compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in interleukin-6

  To determine if the TP has an impact on interleukin-6 compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in interleukin-10

  To determine if the TP has an impact on interleukin-10 compared to placebo

  Baseline, Month 1, Month 2, Month 3

• Changes in cold and flu prevalence

  To determine if the TP has an impact on number of days of lost productivity (days taken off from work or school) due to cold/flu symptoms compared to placebo

  Baseline, Month 3

• Changes in subjective stress levels

  To determine if the TP has an impact on stress levels assessed by Cohen's perceived stress scale compared to placebo. The minimum value is 0 and the maximum value is 40. Higher scores mean a worse outcome.

  Baseline, Month 1, Month 2, Month 3

• Changes in sleep quality

  To determine if the TP has an impact on sleep quality assessed by Pittsburgh Sleep Quality Index compared to placebo. The minimum score is 0 and the maximum score is 40. Higher scores mean a worse outcome.

  Baseline, Month 1, Month 2, Month 3

• Changes in total mood disturbances

  To determine if the TP has an impact on total mood disturbance assessed by the Profile of Mood States (POMS) compared to placebo The total mood is calculated by adding the negative subscales (tension, depression, fatigue, confusion, and anger) subtracting the positive subscales (vigor, esteem-related affect).

  Baseline, Month 1, Month 2, Month 3

• Changes in fatigue-inertia

  To determine if the TP has an impact on fatigue-inertia (POMS sub-score) compared to placebo. Min 0, Max 28, higher scores may be associated with worse outcomes.

  Baseline, Month 1, Month 2, Month 3

• Changes in anger-hostility

  To determine if the TP has an impact on anger-hostility (POMS sub-score) compared to placebo. Min 0, max 48, higher scores are associated with worse outcomes.

  Baseline, Month 1, Month 2, Month 3

• Changes in vigor-activity

  To determine if the TP has an impact on vigor-activity (POMS sub-score) compared to placebo. Min 0, max 32, higher scores are associated with better outcomes.

  Baseline, Month 1, Month 2, Month 3

• Changes in confusion-bewilderment

  To determine if the TP has an impact on confusion-bewilderment (POMS sub-score) compared to placebo. Min 0, max 28, and higher scores are associated with worse outcomes.

  Baseline, Month 1, Month 2, Month 3

• Changes in depression-dejection

  To determine if the TP has an impact on depression-dejection (POMS sub-score) compared to placebo. Min 0, max 60, and higher scores are associated with worse outcomes.

  Baseline, Month 1, Month 2, Month 3

• Changes in tension-anxiety

  To determine if the TP has an impact on tension-anxiety (POMS sub-score) compared to placebo. Min 0, max 60, higher scores are associated with worse outcomes.

  Baseline, Month 1, Month 2, Month 3

• Changes in Overall Body Pain/Discomfort Scale

  To determine if the TP has an impact on body pain and discomfort assessed by the Overall Body Pain/Discomfort Scale compared to placebo, which is a validated dually anchored Likert 10-point scale. Min value is 0, the max is 10, and a higher value is a worse outcome.

  Baseline, Month 1, Month 2, Month 3

• Changes in foundation pain

  To determine if the TP has an impact on foundation pain index which is calculated from urinalysis compared to placebo. Min 0 and Max 100, higher scores indicate worse outcomes.

  Baseline, Month 1, Month 2, Month 3

Secondary Outcomes (13)

• Changes in AST as a marker of liver function

  Baseline, Month 3

• Changes in ALT as a marker of liver function

  Baseline, Month 3

• Changes in alkaline phosphatase as a marker of liver function

  Baseline, Month 3

• Changes in creatinine as a marker of kidney function

  Baseline, Month 3

• Changes in potassium as a marker of kidney function

  Baseline, Month 3

Study Arms (2)

Test Product

EXPERIMENTAL

28 participants will be given the test product (TP)

Dietary Supplement: Cannabinol

Placebo

PLACEBO COMPARATOR

28 participants will be given the placebo product.

Other: Placebo

Interventions

Cannabinol DIETARY_SUPPLEMENT

Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.

Test Product

Placebo OTHER

Prospective,1:1 randomization and stratified by birth sex, and double-blinded to the condition of subjects.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index of 19.0 to 34.9 kg/m2 (normal weight through Class I obesity)
• Agree to refrain from alcohol consumption for at least 48 hours prior to each visit.
• Willing to practice acceptable measures of birth control and sexually transmitted infections prevention by using double-barrier contraceptive measures (both males and females) throughout the study duration.
• Willing and able to agree to the requirements and restrictions of this study including fasting before blood draw on all visits for laboratory assessment.
• Willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow any study related evaluations.

You may not qualify if:

• Have a known sensitivity or allergy to any of the investigational products or their ingredients.
• Female participants who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline (visit 2) or male participants of reproductive potential in a heterosexual relationship planning a pregnancy as confirmed at the baseline visit.
• Documented medical history of immune disorder (such as Human immunodeficiency Virus/Acquired immunodeficiency syndrome), hepatitis B or hepatitis C, or reported immune disorder diagnosis.
• Active psychiatric disorder requiring hospitalization within the 12 months prior to screening or currently on medication(s) to treat any psychiatric disorder(s).
• Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's, dementia).
• History of malignancy or those with any first-degree relatives with a history of cancer (e.g., familial cancer disorders) within 5 years.
• History of clinically significant cardiovascular, respiratory, renal, cerebrovascular, metabolic, pulmonary, gastrointestinal, neurological, hematological, autoimmune, lymphatic, psychiatric, chronic pain and sleep disorders, hepatobiliary (with the exception of Gilbert's syndrome or asymptomatic gallstones) or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation.
• Participants with controlled or uncontrolled hypertension including stage 1 hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89 mmHg).
• Consumption of prescription or non-prescription: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, barbiturates, cocaine, ethanol, selective serotonin reuptake inhibitor, protease inhibitors, warfarin, sildenafil, theophylline, tricyclic antidepressants and any other medications
• Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
• Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
• Current or recent use (within one month prior to visit 2) of cannabis (e.g., marijuana) or cannabis related products (e.g., CBD) in any ingestible or inhalable forms.
• Positive urine drug test for THC or drugs of abuse (Amphetamine, cocaine, marijuana, methamphetamine, and opiates) at baseline (visit 2).
• Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
• Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.

Sponsors & Collaborators

• University of South Carolina: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Interventions

Cannabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded of the subjects and research staff.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Between subjects study design.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 28, 2022
• Study Start: January 18, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)