Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Bioavailability of Phytonutrients

Treatments: Drug: Ursolic Acid; Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04421716

HSC20190940H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Ursolic Acid

Experimental group

Description:

Administration of Ursolic Acid twice a day for 2 weeks

Treatment:

Drug: Ursolic Acid

Curcumin

Experimental group

Description:

Administration of Curcumin twice a day for 2 weeks

Treatment:

Drug: Curcumin

Ursolic Acid and Curcumin

Experimental group

Description:

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

Treatment:

Drug: Curcumin

Drug: Ursolic Acid