Clinical trial NCT05212402: Assessing the Effects of a Cannabidiol Derived From Hemp Supplement in Healthy Adults
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Physiological, Biochemical, and Psychometric Impacts of a Brand-Specific Hemp-Derived Cannabidiol Product in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Safety Issues
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2022-01-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between subjects study design.
Primary purpose: OTHER

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.

Detailed description: Cannabis contains several phyto-cannabinoids among which Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are most widely known. THC is the main compound responsible for the psychoactive properties and also deemed responsible for several side-effects associated with cannabis. CBD, on the other hand, is not a strong cannabinoid receptor agonist and lacks psychotropic activity. However, due to its affinity for several other target sites, it is being studied for potential pharmacological properties. The diverse range of interactions at different receptor sites in the human body is believed to be responsible for therapeutic efficacy of CBD in treating kidney fibrosis, metabolic syndrome, anorexia, obesity, amelioration of osteoarthritis as well as several other musculoskeletal diseases. Recent research has also explored the use of CBD to relieve stress and depression, likely due to its agonistic influence on the 5-HT3 receptors as well as improving hippocampal neural growth and development. CBD has also been studied for its anti-oxidant activity, deemed on-par to that of Vitamin C in laboratory studies. The effect of CBD on inflammation and the immune system has been studied. The sedative effects of CBD have been investigated for the potential use of CBD as an anxiolytic and to improve mood as well as sleep. Recent studies have also explored the analgesic and pain-relieving properties of CBD, making it a suitable candidate that needs further investigations. Interestingly, a recent systematic review explored the use of CBD in viral diseases, with several pre-clinical studies indicating CBD as an effective candidate against viral disease. With the spread of the coronavirus disease (COVID-19) pandemic, there has been a strong interest in developing therapies to eliminate or reduce the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. SARS-CoV-2 uses Angiotensin Converting Enzyme (ACE) receptors to gain entry into the human body and penetrate the respiratory system. In a recent in vitro study, pretreatment with CBD in cells expressing ACE-2 receptor was effective in inhibiting the replication of SARS-CoV-2 in those cells. This is an interesting finding where further research is needed to study the influence of CBD consumption on ACE activity. Several studies of CBD safety have demonstrated lack of any safety concerns over a range of different doses. A recent safety study of CBD by Bergamaschi et al. demonstrated absence of any influence on the central nervous system, vital signs or mood changes as well as lack of any side effect observed for doses up to 1500 mg/day (orally) or 30 mg/day (intravenously).It has been hypothesized that the trace amounts of THC present within the CBD extract could potentially be responsible for any side-effects. Therefore, CBD is considered very safe for human consumption in the dose being tested in this study (\<200mg/day). Additional clinical research is required to confirm and support therapeutic use of CBD for being effective in modulating ACE expression, mood, stress, anti-inflammatory, antioxidant, immunomodulating, sedative \& anxiolytic, analgesic, pain relieving and anti-viral therapeutic claims. This research will also help to understand any safety issues with the long-term regular use of CBD on healthy adults. Therefore, this prospective, randomized, double-blind, placebo controlled study will be conducted to explore the physiologic, biochemical, and psychometric impacts of a brand-specific hemp-derived CBD product in healthy adults.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Participants who are on medications as prescribed for any of the aforementioned exclusionary criteria. Participants on stable dose of thyroid medication (no dosage changes within last 3 months) are acceptable.
* 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.
* Fasting blood glucose of ≥160 mg/dL (after a repeat that confirms the original result) at screening.
* Any other condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.

Primary outcomes:
measure: Changes in angiotensin-renin converting enzyme (ACE)
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in white blood cell count
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in red blood cell count
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in hemoglobin
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in hematocrit
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in mean corpuscular volume
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in mean corpuscular hemoglobin concentration
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in red blood cell distribution width
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in platelet count
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in mean platelet volume
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in absolute and relative neutrophils
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in absolute and relative lymphocytes
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in absolute and relative monocytes
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in absolute and relative eosinophils
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in absolute and relative basophils
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in TNF-alpha
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in interleukin-6
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in interleukin-10
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in cold and flu prevalence
timeFrame: Baseline, Month 3
measure: Changes in subjective stress levels
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in sleep quality
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in total mood disturbances
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in fatigue-inertia
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in anger-hostility
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in vigor-activity
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in confusion-bewilderment
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in depression-dejection
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in tension-anxiety
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in Overall Body Pain/Discomfort Scale
timeFrame: Baseline, Month 1, Month 2, Month 3
measure: Changes in foundation pain
timeFrame: Baseline, Month 1, Month 2, Month 3
Secondary outcomes:
measure: Changes in AST as a marker of liver function
timeFrame: Baseline, Month 3
measure: Changes in ALT as a marker of liver function
timeFrame: Baseline, Month 3
measure: Changes in alkaline phosphatase as a marker of liver function
timeFrame: Baseline, Month 3
measure: Changes in creatinine as a marker of kidney function
timeFrame: Baseline, Month 3
measure: Changes in potassium as a marker of kidney function
timeFrame: Baseline, Month 3
measure: Changes in blood urea nitrogen as a marker of kidney function
timeFrame: Baseline, Month 3
measure: Changes in blood glucose
timeFrame: Baseline, Month 3
measure: Changes in electrolyte balance
timeFrame: Baseline, Month 3
measure: Changes in serum albumin
timeFrame: Baseline, Month 3
measure: Changes in serum albumin/globulin ratio
timeFrame: Baseline, Month 3
measure: Changes in total serum bilirubin serum
timeFrame: Baseline, Month 3
measure: Changes in total serum protein
timeFrame: Baseline, Month 3
measure: Changes in blood urea nitrogen
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: