An interventional study of Cannabidiol (CBD) powder formulation and Cannabidiol (CBD) Oil based tincture formulation in Metabolism, Liver Function and Pharmacokinetics, sponsored by Colorado State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Colorado State University · Not applicable, Interventional, and Basic science
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.
Colorado State University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Separated by a minimum of 4 days.
Dietary Supplement: Cannabidiol (CBD) powder formulation · Dietary Supplement: CBD matching Placebo
Separated by a minimum of 14 days.
Dietary Supplement: Cannabidiol (CBD) powder formulation · Dietary Supplement: Cannabidiol (CBD) Oil based tincture formulation · Dietary Supplement: Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation · Dietary Supplement: Cannabidiol (CBD) Gum Arabic, sorbitol base formulation · Dietary Supplement: Cannabidiol (CBD) Isolate in water 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)
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.)
10% CBD Gum Arabic, maltodextrin base(Formulation 126: Water soluble. Contains gum arabic and maltodextrin)
10% CBD Gum Arabic, sorbitol base (Formulation 213: Water soluble. Contains gum arabic and sorbitol)
Pure CBD as crystalline powder (\>99% purity) (Formulation 625 Not water soluble)
Matching Placebo
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate
| Milestone | All Study Participants |
|---|---|
| Started | 26 |
| Formulation 126 without meal, | 15 |
| Formulation 213 without meal | 14 |
| Formulation 625 without meal | 16 |
| Formulation 725 without meal | 14 |
| Formulation 088 without meal, | 15 |
| Formulation 725 with meal | 14 |
| Placebo with meal | 14 |
| Completed | 14 |
| Not completed | 12 |
| Withdrew: Long term illness | 1 |
| Withdrew: Bmi too low | 9 |
| Withdrew: Geographic location | 1 |
| Withdrew: Discontinued scheduling conflict | 1 |
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).
| minutes | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | 116.3 ± 76 | 35.4 ± 13.5 | 51.8 ± 24.2 | 129.5 ± 89.6 | 38.2 ± 24.9 |
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).
| ng/mL | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | 0.5 ± 0.2 | 3.1 ± 2.1 | 2.2 ± 2.0 | 0.4 ± 0.6 | 1.8 ± 1.5 |
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).
| minutes x ng/mL | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | 62.8 ± 29.7 | 272.3 ± 176 | 208.6 ± 151.1 | 46 ± 59.4 | 177.3 ± 104.8 |
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).
| minutes x ng/mL | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | — | 385.2 ± 226.6 | 367.6 ± 217.1 | — | 301.6 ± 221.9 |
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).
| minutes | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | 280.7 ± 141.5 | 171.0 ± 129.2 | 140.5 ± 96.6 | 442.7 ± 451.0 | 133.1 ± 26.7 |
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).
No measurements were reported for this outcome.
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).
| 1/h | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | 00.003 ± .001 | .006 ± .003 | .006 ± .002 | 0.003 ± .002 | 0.005 ± .001 |
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).
| mL, 1 L is equal to 1,000 mL | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|
| CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | — | 11836405 ± 7642484 | 13130100 ± 6339554 | — | 22687960 ± 16435999 |
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).
| minutes | Formulation 725 |
|---|---|
| Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal | 113.6 ± 70.5 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L).
| ng/mL. 1 L is equal to 1,000 mL. | Formulation 725 |
|---|---|
| Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal | 2.9 ± 1.3 |
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).
| min x ng/mL | Formulation 725 |
|---|---|
| Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal | 397 ± 167 |
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).
No measurements were reported for this outcome.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h).
| minutes, 1 hour is equal to 60 minutes. | Formulation 725 |
|---|---|
| Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal | 248.6 ± 304.6 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h).
No measurements were reported for this outcome.
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h).
| 1/hour | Formulation 725 |
|---|---|
| Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal | 0.005 ± 0.002 |
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L).
No measurements were reported for this outcome.
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.
| (kcal/min) x min | Formulation 725 | Placebo |
|---|---|---|
| Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry | 58.83 ± 14.3 | 55.28 ± 27.62 |
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.
| min x mg/dL | Formulation 725 | Placebo |
|---|---|---|
| Ingested CBD on Postprandial Metabolism Via Measurements of Glucose | 18634.8 ± 2651.8 | 19001.72 ± 4037.1 |
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.
| min x mU/L | Formulation 725 | Placebo |
|---|---|---|
| Ingested CBD on Postprandial Metabolism Via Measurements of Insulin | 7043.3 ± 4780.8 | 6934.75 ± 4556.64 |
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.
| min x mg/dL | Formulation 725 | Placebo |
|---|---|---|
| Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides | 24978.8 ± 9538.7 | 30605.36 ± 17037.6 |
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).
| U/L | Placebo | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|---|
| 0 minutes | 26.1 ± 10.1 | 28 ± 10.9 | 27.5 ± 8.4 | 29 ± 10.6 | 30.5 ± 11.2 | 27.7 ± 9.1 |
| 60 minutes | 26.9 ± 10.8 | 27.9 ± 10 | 29.3 ± 8.1 | 29.1 ± 9.8 | 30.4 ± 11 | 27.3 ± 8.7 |
| 240 minutes | 26.0 ± 11.2 | 28.6 ± 10.6 | 28.2 ± 7.9 | 28.7 ± 10.5 | 30.7 ± 11.5 | 27.6 ± 9.8 |
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.
| g/dL | Placebo | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|---|
| 0 minutes | 3.6 ± 0.3 | 3.9 ± 0.3 | 3.9 ± 0.2 | 3.8 ± 0.3 | 3.8 ± 0.3 | 3.8 ± 0.3 |
| 60 minutes | 3.6 ± 0.2 | 3.8 ± 0.3 | 3.8 ± 0.3 | 3.8 ± 0.2 | 3.8 ± 0.2 | 3.8 ± 0.2 |
| 240 minutes | 3.4 ± 0.3 | 3.9 ± 0.3 | 3.9 ± 0.3 | 3.9 ± 0.2 | 4.0 ± 0.2 | 3.9 ± 0.2 |
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.
| U/L | Placebo | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|---|
| 0 minutes | 62.1 ± 8.6 | 62.5 ± 7.9 | 63.6 ± 10.8 | 60.3 ± 6.8 | 61.9 ± 9.4 | 60.4 ± 12 |
| 60 minutes | 62.9 ± 9.8 | 60.5 ± 7.2 | 61.9 ± 11 | 61 ± 8.7 | 61.6 ± 9.3 | 60.9 ± 11.4 |
| 240 minutes | 58.8 ± 8.5 | 60.2 ± 8.0 | 61.4 ± 9.6 | 62.1 ± 9.5 | 62.3 ± 9.2 | 61 ± 12.6 |
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.
| U/L | Placebo | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|---|
| 0 minutes | 28.0 ± 12.3 | 30.5 ± 4.1 | 30.2 ± 3.4 | 33.5 ± 7 | 30.6 ± 7.3 | 29.2 ± 5 |
| 60 minutes | 30.7 ± 10.4 | 30.6 ± 4.6 | 29.4 ± 8.7 | 30.9 ± 5.1 | 31.4 ± 7.4 | 28.9 ± 4.3 |
| 240 minutes | 29.4 ± 10.1 | 31.1 ± 6.8 | 30.3 ± 4.1 | 30.4 ± 5.9 | 31.9 ± 7.5 | 29.6 ± 4.4 |
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.
| mg/dL | Placebo | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|---|
| 0 minutes | 0.8 ± 0.3 | 1 ± .3 | 1 ± .6 | 1 ± .4 | .9 ± .2 | .9 ± .4 |
| 60 minutes | 0.8 ± 0.3 | 0.9 ± 0.2 | 1 ± 0.6 | 1 ± 0.4 | 0.9 ± 0.2 | 0.9 ± 0.4 |
| 240 minutes | 0.8 ± 0.3 | 1 ± 0.3 | 1.1 ± 0.6 | 1.1 ± 0.4 | 1 ± 0.3 | 1 ± 0.4 |
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.
| mg/dL | Placebo | Formulation 088 | Formulation 126 | Formulation 213 | Formulation 625 | Formulation 725 |
|---|---|---|---|---|---|---|
| 0 minutes | 15.1 ± 2.7 | 14.6 ± 2.8 | 15.4 ± 4.5 | 15.4 ± 3.9 | 15 ± 3.6 | 15.9 ± 3.3 |
| 60 minutes | 14.6 ± 2.9 | 14.4 ± 2.8 | 15.1 ± 4.6 | 15.5 ± 4.1 | 14.8 ± 3.9 | 15.3 ± 3.3 |
| 240 minutes | 13.9 ± 2.5 | 13.4 ± 2.5 | 14 ± 4.2 | 14.3 ± 3.5 | 13.8 ± 3.7 | 14.1 ± 3.1 |
At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo.
| kcal/day | Formulation 725 | Placebo |
|---|---|---|
| CBD on Postprandial Metabolism Via Indirect Calorimetry | 1751.7 ± 271.96 | 1755.31 ± 289.97 |
Collected over Throughout the seven study visits spread out over 10-12 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo With a Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Formulation 725 With a Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Formulation 725 Without Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Formulation 088 Without a Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Formulation 126 Without a Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Formulation 213 Without a Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Formulation 625 Without a Meal | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | Over Number of Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Over Number of Study Participants |
|---|---|
| Female | 9 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | Over Number of Study Participants |
|---|
| Region of Enrollment(participants) | Over Number of Study Participants |
|---|---|
| United States | 26 |
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Colorado State University