Interaction Between Cannabidiol, Meal Ingestion, and Liver Function

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.

Conditions

• Metabolism
• Liver Function
• Pharmacokinetics

Interventions

DIETARY_SUPPLEMENT

Cannabidiol (CBD) powder formulation

T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate (Formulation 725: Water soluble.Contains sorbitol)

DIETARY_SUPPLEMENT

Cannabidiol (CBD) Oil based tincture formulation

30 mg CBD isolate in MCT oil,1:1 ratio of CBD to Medium Chain Triglycerides oil. (Formulation 088: Not water soluble. Contains medium chain triglyceride coconut oil.)

DIETARY_SUPPLEMENT

Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation

10% CBD Gum Arabic, maltodextrin base(Formulation 126: Water soluble. Contains gum arabic and maltodextrin)

DIETARY_SUPPLEMENT

Cannabidiol (CBD) Gum Arabic, sorbitol base formulation

10% CBD Gum Arabic, sorbitol base (Formulation 213: Water soluble. Contains gum arabic and sorbitol)

DIETARY_SUPPLEMENT

Cannabidiol (CBD) Isolate in water formulation

Pure CBD as crystalline powder (\>99% purity) (Formulation 625 Not water soluble)

DIETARY_SUPPLEMENT

CBD matching Placebo

Matching Placebo

Sponsors & Collaborators

• Colorado State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-20

Primary Completion

2021-12-09

Completion

2021-12-09

Countries

• United States

Study Locations