CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Cannabidiol (CBD) powder formulation +5 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04971837
NCT04971837N/ACompleted
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Interaction Between Cannabidiol, Meal Ingestion, and Liver Function

Colorado State University·interventional·Posted Jul 22, 2021·Updated Nov 15, 2024

In Brief

A clinical study evaluating Cannabidiol (CBD) powder formulation, Cannabidiol (CBD) Oil based tincture formulation, and 4 other interventions for Metabolism and 2 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolism, Liver Function, Pharmacokinetics
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 22, 2021
Enrollment StartMay 20, 2021
Primary CompletionDec 9, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.9 years ago

Interventions

Cannabidiol (CBD) powder formulationdietary

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)

Cannabidiol (CBD) Oil based tincture formulationdietary

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.)

Cannabidiol (CBD) Gum Arabic, maltodextrin base formulationdietary

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

Cannabidiol (CBD) Gum Arabic, sorbitol base formulationdietary

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

Cannabidiol (CBD) Isolate in water formulationdietary

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

CBD matching Placebodietary

Matching Placebo