Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid
- Conditions
- Bioavailability of Phytonutrients
- Interventions
- Registration Number
- NCT04421716
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
- Be able to give informed consent
- Be men age 18 or older
- Able to stop supplements
- Unable to give informed consent
- Age < 18
- Woman
- Prisoners
- Diagnosed cancer
- Unable to swallow pills
- Unable to stop supplements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Curcumin Curcumin Administration of Curcumin twice a day for 2 weeks Ursolic Acid Ursolic Acid Administration of Ursolic Acid twice a day for 2 weeks Ursolic Acid and Curcumin Ursolic Acid 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 Ursolic Acid and Curcumin 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
- Primary Outcome Measures
Name Time Method 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.
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.
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 Outcome Measures
Name Time Method Microbiome Alpha Diversity Baseline to 2 weeks Number of bacteria collected from rectal culture sample will be assessed before and after each exposure
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.
Trial Locations
- Locations (1)
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States