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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two Visits Including A Test Meal | Experimental | Separated by a minimum of 4 days. |
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| Five Visits Not Involving A Test Meal | Experimental | Separated by a minimum of 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol (CBD) powder formulation | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes). | Venous blood will be sampled at standardized intervals: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Cmax (ng/mL). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-4 (min x ng/mL). | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-inf (mins x ng/mL). |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University, Dept. of Health and Exercise Science | Fort Collins | Colorado | 80523-1582 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35631293 | Result | Abbotts KSS, Ewell TR, Butterklee HM, Bomar MC, Akagi N, Dooley GP, Bell C. Cannabidiol and Cannabidiol Metabolites: Pharmacokinetics, Interaction with Food, and Influence on Liver Function. Nutrients. 2022 May 21;14(10):2152. doi: 10.3390/nu14102152. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Experimental: Two Visits Including A Test Meal Separated by a minimum of 4 days. 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: CBD matching Placebo Matching Placebo Experimental: Five Visits Not Involving A Test Meal Separated by a minimum of 14 days. 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 formulation10% 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 1, 2022 |
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The CBD and placebo formulations are prepared, bottled and coded by Caliper Foods. The participants will receive a coded bottle to consume of the different formulations of CBD and placebo.
| Cannabidiol (CBD) Oil based tincture formulation | Dietary Supplement | 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 formulation | Dietary Supplement | 10% CBD Gum Arabic, maltodextrin base(Formulation 126: Water soluble. Contains gum arabic and maltodextrin) |
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| Cannabidiol (CBD) Gum Arabic, sorbitol base formulation | Dietary Supplement | 10% CBD Gum Arabic, sorbitol base (Formulation 213: Water soluble. Contains gum arabic and sorbitol) |
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| Cannabidiol (CBD) Isolate in water formulation | Dietary Supplement | Pure CBD as crystalline powder (>99% purity) (Formulation 625 Not water soluble) |
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| CBD matching Placebo | Dietary Supplement | Matching Placebo |
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| Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate t1/2 (mins). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Rate at Which CBD is Absorbed Into the Body (Ka) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ka(1/h). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ke (1/h). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Vd (L). | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts the time to attain peak circulating concentration Tmax (mins). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L). | venous blood will be sampled at standardized intervals over: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-4 (min x ng/mL). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter AUC 0-inf of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-inf (min x ng/mL). | venous blood will be sampled at standardized intervals 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter Ka of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Pharmacokinetic Parameter Vd of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L). | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
| Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry | At the 2 randomized visits Including a Test Meal Thermic Effect of Feeding (TEF) Under the Curve was calculated from standardized intervals prior to and after ingestion of a liquid meal and a single dose of Formulation 725. | Randomized visit Including a test meal collected during 235 minutes of TEF |
| Ingested CBD on Postprandial Metabolism Via Measurements of Glucose | At the 2 randomized visits Including a Test Meal, glucose Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. |
| Ingested CBD on Postprandial Metabolism Via Measurements of Insulin | At the 2 randomized visits Including a Test Meal insulin Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. |
| Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides | At the 2 randomized visits Including a Test Meal triglyceride Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. |
| Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alanine aminotransferase (ALT). | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
| Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for albumin. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
| Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alkaline phosphatase. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
| Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for aspartate aminotransferase. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
| Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for total bilirubin. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
| Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for blood urea. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
| CBD on Postprandial Metabolism Via Indirect Calorimetry | At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo. | Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate |
| Formulation 126 Without Meal, |
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| Formulation 213 Without Meal |
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| Formulation 625 Without Meal |
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| Formulation 725 Without Meal |
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| Formulation 088 Without Meal, |
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| Formulation 725 With Meal |
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| Placebo With Meal |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Over Number of Study Participants | Randomized Cross over study |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes). | Posted | Mean | Standard Deviation | minutes | Venous blood will be sampled at standardized intervals: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Cmax (ng/mL). | Posted | Mean | Standard Deviation | ng/mL | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-4 (min x ng/mL). | Posted | Mean | Standard Deviation | minutes x ng/mL | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-inf (mins x ng/mL). | Data not collected or analyzed in groups listing 0 for overall number of participants analyzed. | Posted | Mean | Standard Deviation | minutes x ng/mL | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| 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 | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate t1/2 (mins). | Posted | Mean | Standard Deviation | minutes | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Rate at Which CBD is Absorbed Into the Body (Ka) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ka(1/h). | Outcome measure not collected | Posted | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ke (1/h). | Posted | Mean | Standard Deviation | 1/h | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Vd (L). | Data not collected or analyzed in groups listing 0 for overall number of participants analyzed. | Posted | Mean | Standard Error | mL, 1 L is equal to 1,000 mL | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts the time to attain peak circulating concentration Tmax (mins). | Posted | Mean | Standard Deviation | minutes | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L). | Posted | Mean | Standard Deviation | ng/mL. 1 L is equal to 1,000 mL. | venous blood will be sampled at standardized intervals over: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-4 (min x ng/mL). | Posted | Mean | Standard Deviation | min x ng/mL | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter AUC 0-inf of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-inf (min x ng/mL). | Data not Collected | Posted | venous blood will be sampled at standardized intervals 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h). | Posted | Mean | Standard Deviation | minutes, 1 hour is equal to 60 minutes. | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter Ka of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h). | Data not collected | Posted | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h). | Posted | Mean | Standard Deviation | 1/hour | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Pharmacokinetic Parameter Vd of Formulation 725 After a Standardized Meal | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L). | Data Not Collected | Posted | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. |
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| Primary | Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry | At the 2 randomized visits Including a Test Meal Thermic Effect of Feeding (TEF) Under the Curve was calculated from standardized intervals prior to and after ingestion of a liquid meal and a single dose of Formulation 725. | The thermic effect of feeding refers to the increase in energy expenditure after eating. On the X-axis, the independent variable is time, and the unit is minutes (min). On the Y-axis, the dependent variable is energy expenditure, and the unit is kilocalories per minute (kcal/min). Thus, the unit for area under the curve is kcal/min X min. | Posted | Mean | Standard Deviation | (kcal/min) x min | Randomized visit Including a test meal collected during 235 minutes of TEF |
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| Primary | Ingested CBD on Postprandial Metabolism Via Measurements of Glucose | At the 2 randomized visits Including a Test Meal, glucose Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. | Posted | Mean | Standard Deviation | min x mg/dL | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. |
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| Primary | Ingested CBD on Postprandial Metabolism Via Measurements of Insulin | At the 2 randomized visits Including a Test Meal insulin Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. | Posted | Mean | Standard Deviation | min x mU/L | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. |
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| Primary | Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides | At the 2 randomized visits Including a Test Meal triglyceride Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. | Posted | Mean | Standard Deviation | min x mg/dL | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. |
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| Primary | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alanine aminotransferase (ALT). | Posted | Mean | Standard Deviation | U/L | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
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| Primary | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for albumin. | Posted | Mean | Standard Deviation | g/dL | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
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| Primary | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alkaline phosphatase. | Posted | Mean | Standard Deviation | U/L | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
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| Primary | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for aspartate aminotransferase. | Posted | Mean | Standard Deviation | U/L | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
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| Primary | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for total bilirubin. | Posted | Mean | Standard Deviation | mg/dL | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
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| Primary | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for blood urea. | Posted | Mean | Standard Deviation | mg/dL | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days |
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| Primary | CBD on Postprandial Metabolism Via Indirect Calorimetry | At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo. | Posted | Mean | Standard Deviation | kcal/day | Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate |
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Throughout the seven study visits spread out over 10-12 weeks.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo With a Meal | Separated by a minimum of 4 days. CBD matching Placebo: Matching Placebo | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | Formulation 725 With a Meal | Separated by a minimum of 14 days. 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) Cannabidiol (CBD) Isolate in water formulation: formulation (725) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Formulation 725 Without Meal | Separated by a minimum of 14 days. 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) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Formulation 088 Without a Meal | Separated by a minimum of 14 days. Cannabidiol (CBD) Oil based tincture formulation: 30 mg CBD isolate in medium-chain triglyceride (MCT) oil (1:1 ratio of CBD to Medium Chain Triglycerides oil) (Formulation 088 not water soluble) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG004 | Formulation 126 Without a Meal | Separated by a minimum of 14 days. Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation: 10% CBD Gum Arabic, maltodextrin base (Formulation 126 water soluble ) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG005 | Formulation 213 Without a Meal | Separated by a minimum of 14 days. Cannabidiol (CBD) Gum Arabic, sorbitol base formulation: 10% CBD Gum Arabic, sorbitol base (Formulation 213 water soluble) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG006 | Formulation 625 Without a Meal | Separated by a minimum of 14 days. Pure CBD as crystalline powder (>99% purity) (Formulation 625 Not water soluble) | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Bell, Director, Laboratory of Integrative Physiology | Colorado State University | (970) 491-7522 | Christopher.Bell@colostate.edu |
| Nov 17, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D006170 | Gum Arabic |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
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| >=65 years |
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| OG004 |
| Formulation 725 |
Water soluble. Contains sorbitol |
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| OG004 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG004 | Formulation 725 | Water soluble. Contains sorbitol |
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| OG004 | Formulation 725 | Water soluble. Contains sorbitol |
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| OG004 | Formulation 725 | Water soluble. Contains sorbitol |
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| OG004 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity)
| OG004 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG005 | Formulation 725 | Water soluble. Contains sorbitol |
|
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG005 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG005 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG005 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG005 | Formulation 725 | Water soluble. Contains sorbitol |
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Not water soluble. Pure CBD as crystalline powder (>99% purity) |
| OG005 | Formulation 725 | Water soluble. Contains sorbitol |
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