Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

The University of Texas System (UT) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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