Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid
Purpose
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.
Condition
- Bioavailability of Phytonutrients
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Be able to give informed consent - Be men age 18 or older - Able to stop supplements
Exclusion Criteria
- Unable to give informed consent - Age < 18 - Woman - Prisoners - Diagnosed cancer - Unable to swallow pills - Unable to stop supplements
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ursolic Acid |
Administration of Ursolic Acid twice a day for 2 weeks |
|
|
Experimental Curcumin |
Administration of Curcumin twice a day for 2 weeks |
|
|
Experimental Ursolic Acid and Curcumin |
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 |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center at San Antonio
Study Contact
Detailed Description
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.