Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

NCT ID: NCT04421716

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2021-04-16

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.

Conditions

Bioavailability of Phytonutrients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ursolic Acid

Administration of Ursolic Acid twice a day for 2 weeks

Group Type: EXPERIMENTAL

Ursolic Acid

Intervention Type: DRUG

Ursolic Acid 150mg

Curcumin

Administration of Curcumin twice a day for 2 weeks

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Curcumin 600mg

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

Group Type: EXPERIMENTAL

Ursolic Acid

Intervention Type: DRUG

Ursolic Acid 150mg

Curcumin

Intervention Type: DRUG

Curcumin 600mg

Interventions

Ursolic Acid

Ursolic Acid 150mg

Intervention Type: DRUG

Curcumin

Curcumin 600mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Liss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20190940H

Identifier Type: -

Identifier Source: org_study_id