NCT04971837

Interaction Between Cannabidiol, Meal Ingestion, and Liver Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Pharmacokinetics describes the speed in which something that is ingested is made available within the body (i.e. bioavailability).There are many different preparations/formulations of CBD and they may differ from one another with regards to their pharmacokinetics. One important consideration when evaluating CBD formulations is the pharmacokinetic goal and intended use. For example, if the indication for the CBD is to treat acute pain, then a faster time to peak concentration (Tmax) and higher maximal concentration (Cmax) may be desirable, and also may help to decrease the risk of overdose due to premature repeat self administration. Alternatively, as a chronic treatment for anxiety, a larger area under the curve (AUC) may be preferable if a user follows a regular dosing schedule. One purpose of the proposed project is to compare the pharmacokinetics of different formulations of CBD. The formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). Several previous studies have demonstrated an influence of eating on the pharmacokinetics of ingested CBD. The general consensus appears to be that prior ingestion of a high-fat meal increases the maximal concentration of circulating CBD (Cmax) and lowers the time to attain peak circulating concentration (Tmax). One purpose of the proposed project is to study the influence of a standardized meal on the pharmacokinetics of a CBD formulation. Little is known about the influence of ingested CBD on postprandial metabolism. The thermic effect of feeding (i.e. the increase in metabolic rate above resting metabolism) is considered an important physiological determinant of energy balance, and therefore also of weight gain or loss. Further, the dynamics of circulating glucose and triglycerides following a meal are reflective of metabolic health and predictive of future cardiometabolic disease risk. CBD has been purported to have a variety of beneficial physiological properties, including anti-inflammatory and antioxidant actions. Either of these individual properties alone could favorably modify postprandial metabolism, given that CBD potentially does both, it appears likely that CBD might improve the physiological regulation of postprandial metabolism. One purpose of the proposed project is to determine the influence of CBD on postprandial metabolism. The liver plays a critical regulatory role in postprandial metabolism, and also with the physiological processing of cannabinoids. The relationship between the use of cannabinoids and liver health is unclear. While early studies implied that exposure of the liver to very high daily dosing of cannabinoids may be detrimental, more recent studies are suggesting that some cannabinoids, including CBD, may have therapeutic potential for the treatment of non-alcoholic fatty liver disease. The acute effects of low dose CBD (e.g. 30 mg) on liver function in healthy adults have not been well described, and may be influenced by the formulation of the CBD product (i.e. whether it is water or lipid soluble). One purpose of the proposed project is to determine the acute influence of different formulations of CBD on circulating markers of liver function.

Conditions

• Metabolism
• Liver Function
• Pharmacokinetics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-12-09
• Completion: 2021-12-09
• First posted: 2021-07-22
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

1 site across 1 country: United States