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The primary objective of this research is to investigate the bioavailability of curcumin (CURC) and ursolic acid (UA) in a phase I clinical trial in healthy men and obtain biological material for bioavailability analysis.
Once a subject is consented and assigned to a cohort, the subject may undergo a digital rectal exam (DRE) and rectal swab fecal collection and provide research blood (including CBC and CMP safety labs) and urine. Medical history data will be collected and reviewed. The PI and/or study staff will provide supplement administration and supplement diary education prior to the subject starting their dose of UA, CURC, or UA and CURC combination. Pharmacokinetic (PK) and pharmacodynamic (PD) assessments will be collected at pre-dose and 6 and 24 hours after the first dose. Urine will also be collected at pre dose and 24 hours post dose. The dosing period will be for a total of 2 weeks (± 3 days). On the last day of dosing, subjects will attend a research only visit at which the subject may undergo a digital rectal exam (DRE) and rectal swab fecal collection and provide research blood and urine. At this time, the subject's supplement diary will be reviewed and a safety/AE assessment will be completed. In addition, research CBC and CMP safety labs will be collected. If a subject initially enrolled in Cohort 1 or 2 decides to continue in Cohort 3, the subject will undergo a wash out period of at least 4 weeks and repeat all study procedures for Cohort 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ursolic Acid | Experimental | Administration of Ursolic Acid twice a day for 2 weeks |
|
| Curcumin | Experimental | Administration of Curcumin twice a day for 2 weeks |
|
| Ursolic Acid and Curcumin | Experimental | Administration of Ursolic Acid and Curcumin. If subjects from Cohort 1 or 2 wish to continue in the study, they will undergo a washout period of at least 4 weeks before participating in Cohort 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursolic Acid | Drug | Ursolic Acid 150mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number, frequency, duration, and relation of toxicity events | Safety will be compared to evaluate the number, frequency, duration, and relation of toxicity events to CURC and UA, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. | Baseline to 2 weeks |
| Peak serum concentration | Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed. | Baseline to 2 weeks |
| Time to reach peak serum concentration | The pharmacokinetic parameter, the area under the curve (Tmax) representing the time it takes to reach Cmax of ursolic acid, curcumin, and their metabolites will be graphed. | Baseline to 2 weeks |
| Half-life | The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed. | Baseline to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome Alpha Diversity | Number of bacteria collected from rectal culture sample will be assessed before and after each exposure | Baseline to 2 weeks |
| Microbiome Beta Diversity | Proportions of bacteria collected from rectal culture sample will be assessed before and after each exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Liss, MD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
De-identified individual participant data will be available upon request.
De-identified data will be available upon request following study completion for approx. 1 year.
Access available upon request.
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| ID | Term |
|---|---|
| D000097245 | Ursolic Acid |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
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Cohort 1 and 2 will receive either UA or CURC and Cohort 3 will receive a combination of UA and CURC. Subjects initially enrolled in Cohorts 1 and 2 may have the option to continue in Cohort 3.
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| Curcumin |
| Drug |
Curcumin 600mg |
|
| Baseline to 2 weeks |
| Metabolite Panels | Metabolite panels will be placed into quartiles and compared to predicted function from the bioinformatics tool Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) software. | Baseline to 2 weeks |
| D009930 |
| Organic Chemicals |
| D012502 | Sapogenins |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |