Trial Outcomes & Findings for Interaction Between Cannabidiol, Meal Ingestion, and Liver Function (NCT NCT04971837)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

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.

Results posted on

2024-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	26
Overall Study Formulation 126 Without Meal,	15
Overall Study Formulation 213 Without Meal	14
Overall Study Formulation 625 Without Meal	16
Overall Study Formulation 725 Without Meal	14
Overall Study Formulation 088 Without Meal,	15
Overall Study Formulation 725 With Meal	14
Overall Study Placebo With Meal	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Long Term Illness	1
Overall Study BMI too low	9
Overall Study geographic location	1
Overall Study Discontinued scheduling conflict	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Over Number of Study Participants n=26 Participants Randomized Cross over study
Age, Categorical <=18 years	0 Participants n=26 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=26 Participants
Age, Categorical >=65 years	0 Participants n=26 Participants
Sex: Female, Male Female	9 Participants n=26 Participants
Sex: Female, Male Male	17 Participants n=26 Participants
Region of Enrollment United States	26 participants n=26 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=12 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=11 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD	116.3 minutes Standard Deviation 76	35.4 minutes Standard Deviation 13.5	51.8 minutes Standard Deviation 24.2	129.5 minutes Standard Deviation 89.6	38.2 minutes Standard Deviation 24.9	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=12 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=11 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD	0.5 ng/mL Standard Deviation 0.2	3.1 ng/mL Standard Deviation 2.1	2.2 ng/mL Standard Deviation 2.0	0.4 ng/mL Standard Deviation 0.6	1.8 ng/mL Standard Deviation 1.5	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=12 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=11 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD	62.8 minutes x ng/mL Standard Deviation 29.7	272.3 minutes x ng/mL Standard Deviation 176	208.6 minutes x ng/mL Standard Deviation 151.1	46 minutes x ng/mL Standard Deviation 59.4	177.3 minutes x ng/mL Standard Deviation 104.8	—

PRIMARY outcome

Timeframe: 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.

Population: Data not collected or analyzed in groups listing 0 for overall number of participants analyzed.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=6 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=5 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=2 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD	—	385.2 minutes x ng/mL Standard Deviation 226.6	367.6 minutes x ng/mL Standard Deviation 217.1	—	301.6 minutes x ng/mL Standard Deviation 221.9	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=5 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=11 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=3 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=13 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
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 minutes Standard Deviation 141.5	171.0 minutes Standard Deviation 129.2	140.5 minutes Standard Deviation 96.6	442.7 minutes Standard Deviation 451.0	133.1 minutes Standard Deviation 26.7	—

PRIMARY outcome

Timeframe: 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.

Population: Outcome measure not collected

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 measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=5 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=11 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=3 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=13 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD	00.003 1/h Standard Deviation .001	.006 1/h Standard Deviation .003	.006 1/h Standard Deviation .002	0.003 1/h Standard Deviation .002	0.005 1/h Standard Deviation .001	—

PRIMARY outcome

Timeframe: 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.

Population: Data not collected or analyzed in groups listing 0 for overall number of participants analyzed.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=6 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=5 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=2 Participants Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD	—	11836405 mL, 1 L is equal to 1,000 mL Standard Error 7642484	13130100 mL, 1 L is equal to 1,000 mL Standard Error 6339554	—	22687960 mL, 1 L is equal to 1,000 mL Standard Error 16435999	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal	113.6 minutes Standard Deviation 70.5	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L).

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal	2.9 ng/mL. 1 L is equal to 1,000 mL. Standard Deviation 1.3	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal	397 min x ng/mL Standard Deviation 167	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Population: Data not Collected

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).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h).

Outcome measures

Outcome measures
Measure	Formulation 088 n=7 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal	248.6 minutes, 1 hour is equal to 60 minutes. Standard Deviation 304.6	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Population: Data not collected

At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h).

Outcome measures

Outcome measures
Measure	Formulation 088 n=7 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal	0.005 1/hour Standard Deviation 0.002	—	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Population: Data Not Collected

At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Randomized visit Including a test meal collected during 235 minutes of TEF

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry	58.83 (kcal/min) x min Standard Deviation 14.3	55.28 (kcal/min) x min Standard Deviation 27.62	—	—	—	—

PRIMARY outcome

Timeframe: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=13 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Ingested CBD on Postprandial Metabolism Via Measurements of Glucose	18634.8 min x mg/dL Standard Deviation 2651.8	19001.72 min x mg/dL Standard Deviation 4037.1	—	—	—	—

PRIMARY outcome

Timeframe: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=13 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Ingested CBD on Postprandial Metabolism Via Measurements of Insulin	7043.3 min x mU/L Standard Deviation 4780.8	6934.75 min x mU/L Standard Deviation 4556.64	—	—	—	—

PRIMARY outcome

Timeframe: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=10 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides	24978.8 min x mg/dL Standard Deviation 9538.7	30605.36 min x mg/dL Standard Deviation 17037.6	—	—	—	—

PRIMARY outcome

Timeframe: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days

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).

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=14 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 n=14 Participants Water soluble. Contains sorbitol
Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. 0 minutes	26.1 U/L Standard Deviation 10.1	28 U/L Standard Deviation 10.9	27.5 U/L Standard Deviation 8.4	29 U/L Standard Deviation 10.6	30.5 U/L Standard Deviation 11.2	27.7 U/L Standard Deviation 9.1
Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. 60 minutes	26.9 U/L Standard Deviation 10.8	27.9 U/L Standard Deviation 10	29.3 U/L Standard Deviation 8.1	29.1 U/L Standard Deviation 9.8	30.4 U/L Standard Deviation 11	27.3 U/L Standard Deviation 8.7
Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. 240 minutes	26.0 U/L Standard Deviation 11.2	28.6 U/L Standard Deviation 10.6	28.2 U/L Standard Deviation 7.9	28.7 U/L Standard Deviation 10.5	30.7 U/L Standard Deviation 11.5	27.6 U/L Standard Deviation 9.8

PRIMARY outcome

Timeframe: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=14 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 n=14 Participants Water soluble. Contains sorbitol
Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. 0 minutes	3.6 g/dL Standard Deviation 0.3	3.9 g/dL Standard Deviation 0.3	3.9 g/dL Standard Deviation 0.2	3.8 g/dL Standard Deviation 0.3	3.8 g/dL Standard Deviation 0.3	3.8 g/dL Standard Deviation 0.3
Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. 60 minutes	3.6 g/dL Standard Deviation 0.2	3.8 g/dL Standard Deviation 0.3	3.8 g/dL Standard Deviation 0.3	3.8 g/dL Standard Deviation 0.2	3.8 g/dL Standard Deviation 0.2	3.8 g/dL Standard Deviation 0.2
Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. 240 minutes	3.4 g/dL Standard Deviation 0.3	3.9 g/dL Standard Deviation 0.3	3.9 g/dL Standard Deviation 0.3	3.9 g/dL Standard Deviation 0.2	4.0 g/dL Standard Deviation 0.2	3.9 g/dL Standard Deviation 0.2

PRIMARY outcome

Timeframe: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=14 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 n=14 Participants Water soluble. Contains sorbitol
Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. 0 minutes	62.1 U/L Standard Deviation 8.6	62.5 U/L Standard Deviation 7.9	63.6 U/L Standard Deviation 10.8	60.3 U/L Standard Deviation 6.8	61.9 U/L Standard Deviation 9.4	60.4 U/L Standard Deviation 12
Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. 60 minutes	62.9 U/L Standard Deviation 9.8	60.5 U/L Standard Deviation 7.2	61.9 U/L Standard Deviation 11	61 U/L Standard Deviation 8.7	61.6 U/L Standard Deviation 9.3	60.9 U/L Standard Deviation 11.4
Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. 240 minutes	58.8 U/L Standard Deviation 8.5	60.2 U/L Standard Deviation 8.0	61.4 U/L Standard Deviation 9.6	62.1 U/L Standard Deviation 9.5	62.3 U/L Standard Deviation 9.2	61 U/L Standard Deviation 12.6

PRIMARY outcome

Timeframe: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=14 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 n=14 Participants Water soluble. Contains sorbitol
Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. 0 minutes	28.0 U/L Standard Deviation 12.3	30.5 U/L Standard Deviation 4.1	30.2 U/L Standard Deviation 3.4	33.5 U/L Standard Deviation 7	30.6 U/L Standard Deviation 7.3	29.2 U/L Standard Deviation 5
Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. 60 minutes	30.7 U/L Standard Deviation 10.4	30.6 U/L Standard Deviation 4.6	29.4 U/L Standard Deviation 8.7	30.9 U/L Standard Deviation 5.1	31.4 U/L Standard Deviation 7.4	28.9 U/L Standard Deviation 4.3
Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. 240 minutes	29.4 U/L Standard Deviation 10.1	31.1 U/L Standard Deviation 6.8	30.3 U/L Standard Deviation 4.1	30.4 U/L Standard Deviation 5.9	31.9 U/L Standard Deviation 7.5	29.6 U/L Standard Deviation 4.4

PRIMARY outcome

Timeframe: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=14 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 n=14 Participants Water soluble. Contains sorbitol
Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. 0 minutes	0.8 mg/dL Standard Deviation 0.3	1 mg/dL Standard Deviation .3	1 mg/dL Standard Deviation .6	1 mg/dL Standard Deviation .4	.9 mg/dL Standard Deviation .2	.9 mg/dL Standard Deviation .4
Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. 60 minutes	0.8 mg/dL Standard Deviation 0.3	0.9 mg/dL Standard Deviation 0.2	1 mg/dL Standard Deviation 0.6	1 mg/dL Standard Deviation 0.4	0.9 mg/dL Standard Deviation 0.2	0.9 mg/dL Standard Deviation 0.4
Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. 240 minutes	0.8 mg/dL Standard Deviation 0.3	1 mg/dL Standard Deviation 0.3	1.1 mg/dL Standard Deviation 0.6	1.1 mg/dL Standard Deviation 0.4	1 mg/dL Standard Deviation 0.3	1 mg/dL Standard Deviation 0.4

PRIMARY outcome

Timeframe: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days

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.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 n=14 Participants Water soluble. Contains gum arabic and sorbitol	Formulation 625 n=14 Participants Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 n=14 Participants Water soluble. Contains sorbitol	Formulation 725 n=14 Participants Water soluble. Contains sorbitol
Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. 60 minutes	14.6 mg/dL Standard Deviation 2.9	14.4 mg/dL Standard Deviation 2.8	15.1 mg/dL Standard Deviation 4.6	15.5 mg/dL Standard Deviation 4.1	14.8 mg/dL Standard Deviation 3.9	15.3 mg/dL Standard Deviation 3.3
Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. 0 minutes	15.1 mg/dL Standard Deviation 2.7	14.6 mg/dL Standard Deviation 2.8	15.4 mg/dL Standard Deviation 4.5	15.4 mg/dL Standard Deviation 3.9	15 mg/dL Standard Deviation 3.6	15.9 mg/dL Standard Deviation 3.3
Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. 240 minutes	13.9 mg/dL Standard Deviation 2.5	13.4 mg/dL Standard Deviation 2.5	14 mg/dL Standard Deviation 4.2	14.3 mg/dL Standard Deviation 3.5	13.8 mg/dL Standard Deviation 3.7	14.1 mg/dL Standard Deviation 3.1

PRIMARY outcome

Timeframe: Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate

At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo.

Outcome measures

Outcome measures
Measure	Formulation 088 n=14 Participants Not water soluble. Contains medium chain triglyceride coconut oil.	Formulation 126 n=14 Participants Water soluble. Contains gum arabic and maltodextrin	Formulation 213 Water soluble. Contains gum arabic and sorbitol	Formulation 625 Not water soluble. Pure CBD as crystalline powder (\>99% purity)	Formulation 725 Water soluble. Contains sorbitol	Formulation 725 Water soluble. Contains sorbitol
CBD on Postprandial Metabolism Via Indirect Calorimetry	1751.7 kcal/day Standard Deviation 271.96	1755.31 kcal/day Standard Deviation 289.97	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Bell, Director, Laboratory of Integrative Physiology

Colorado State University

Phone: (970) 491-7522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place