Bioavailability of Phytonutrients
Conditions
Brief summary
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.
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.
Interventions
DRUGUrsolic Acid
Ursolic Acid 150mg
DRUGCurcumin
Curcumin 600mg
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number, frequency, duration, and relation of toxicity events | Baseline to 2 weeks | 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. |
| Peak serum concentration | Baseline to 2 weeks | Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed. |
| Time to reach peak serum concentration | Baseline to 2 weeks | 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. |
| Half-life | Baseline to 2 weeks | The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome Beta Diversity | Baseline to 2 weeks | Proportions of bacteria collected from rectal culture sample will be assessed before and after each exposure |
| Metabolite Panels | Baseline to 2 weeks | 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. |
| Microbiome Alpha Diversity | Baseline to 2 weeks | Number of bacteria collected from rectal culture sample will be assessed before and after each exposure |
Countries
United States
Outcome results
None listed