Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04971837
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2021-06-04
Brief Title:
Interaction Between Cannabidiol Meal Ingestion and Liver Function
Sponsor:
Colorado State University
Organization:
Colorado State University
Study Overview
Official Title:
Interaction Between Cannabidiol Meal Ingestion and Liver Function
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 ie bioavailabilityThere are many different preparationsformulations 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 eg 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 ie 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 eg 30 mg on liver function in healthy adults have not been well described and may be influenced by the formulation of the CBD product ie 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
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 eg 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 ie 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 eg 30 mg on liver function in healthy adults have not been well described and may be influenced by the formulation of the CBD product ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None