N/A
N=26
Interaction Between Cannabidiol, Meal Ingestion, and Liver Function
Metabolism · Liver Function · Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT04971837 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD — 116.3; 35.4; 51.8; 129.5 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cannabidiol (CBD) powder formulation (Dietary_supplement); Cannabidiol (CBD) Oil based tincture formulation (Dietary_supplement); Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation (Dietary_supplement); Cannabidiol (CBD) Gum Arabic, sorbitol base formulation (Dietary_supplement); Cannabidiol (CBD) Isolate in water formulation (Dietary_supplement); CBD matching Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colorado State University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD |
116.3; 35.4; 51.8; 129.5; 38.2 | — |
| PRIMARY Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD |
0.5; 3.1; 2.2; 0.4; 1.8 | — |
| PRIMARY Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD |
62.8; 272.3; 208.6; 46; 177.3 | — |
| PRIMARY Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD |
385.2; 367.6; 301.6 | — |
| PRIMARY Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD |
280.7; 171.0; 140.5; 442.7; 133.1 | — |
| PRIMARY Pharmacokinetic Rate at Which CBD is Absorbed Into the Body (Ka) for Different Formulations of CBD |
— | — |
| PRIMARY Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD |
00.003; .006; .006; 0.003; 0.005 | — |
| PRIMARY CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD |
11836405; 13130100; 22687960 | — |
| PRIMARY Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal |
113.6 | — |
| PRIMARY Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal |
2.9 | — |
| PRIMARY Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal |
397 | — |
| PRIMARY Pharmacokinetic Parameter AUC 0-inf of Formulation 725 After a Standardized Meal |
— | — |
| PRIMARY Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal |
248.6 | — |
| PRIMARY Pharmacokinetic Parameter Ka of Formulation 725 After a Standardized Meal |
— | — |
| PRIMARY Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal |
0.005 | — |
| PRIMARY Pharmacokinetic Parameter Vd of Formulation 725 After a Standardized Meal |
— | — |
| PRIMARY Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry |
58.83; 55.28 | — |
| PRIMARY Ingested CBD on Postprandial Metabolism Via Measurements of Glucose |
18634.8; 19001.72 | — |
| PRIMARY Ingested CBD on Postprandial Metabolism Via Measurements of Insulin |
7043.3; 6934.75 | — |
| PRIMARY Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides |
24978.8; 30605.36 | — |
| PRIMARY Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. |
26.1; 28; 27.5; 29; 30.5; 27.7 | — |
| PRIMARY Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. |
3.6; 3.9; 3.9; 3.8; 3.8; 3.8 | — |
| PRIMARY Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. |
62.1; 62.5; 63.6; 60.3; 61.9; 60.4 | — |
| PRIMARY Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. |
28.0; 30.5; 30.2; 33.5; 30.6; 29.2 | — |
| PRIMARY Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. |
0.8; 1; 1; 1; .9; .9 | — |
| PRIMARY Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. |
15.1; 14.6; 15.4; 15.4; 15; 15.9 | — |
| PRIMARY CBD on Postprandial Metabolism Via Indirect Calorimetry |
1751.7; 1755.31 | — |
Summary
According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived products, such as CBD, is highly prevalent across North America. The acceleration of the use of CBD has outpaced our understanding of the associated potential risks and benefits, and the way it is processed within the body.
In the current proposed project, investigators wish to continue our ongoing collaboration with Caliper Foods, a Colorado-based manufacturer of CBD products. The focus of this project is three-fold: (1) investigators will compare the pharmacokinetics of different formulations of ingestible CBD; (2) investigators will examine the potential two-way interaction between a meal and one formulation of ingestible CBD; and, (3) investigators will examine the influence of different formulations of CBD on markers of liver function.
Eligibility Criteria
Inclusion Criteria
- Participants must be greater than 18 years of age
- Weigh more than 110 pounds
- Have a body mass index greater than 25kg/m^2
- Be free of any gastrointestinal or metabolic diseases
- Be able to refrain from use of any Cannabis or cannabis containing products for three days prior to participating in the study.
Exclusion Criteria
- Less than 18 years of age
- Pregnant or breastfeeding
- Food allergies
- Autoimmune disorders or with compromised immune function,
- Celiac disease
- Inflammatory bowel Diseases
- Gastrointestinal cancers
- Diabetes
- HIV
- Adverse reactions to ingesting Cannabis spp. or cannabis-containing products (including, but not limited to, marijuana, CBD oils, or CBD/THC containing food products)
- Taking any of the follow medications: steroids, HMG-CoA reductase inhibitors, calcium channel blockers, antihistamines, HIV antivirals, immune modulators, benzodiazepines, antiarrythmics, antibiotics, anesthetics, antipsychotics, antidepressants, anti-epileptics, beta blockers, proton pump inhibitors, NSAIDs, angiotension II blockers, oral hypoglycemic agents, and sulfonylureas.
Data sourced from ClinicalTrials.gov (NCT04971837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.