Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Completed

CT.gov ID

NCT04421716

Collaborator

(none)

Enrollment

Location

Arms

5.8

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability of Phytonutrients	Drug: Ursolic Acid Drug: Curcumin	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Phase I Clinical Trial Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

Actual Study Start Date :

Oct 20, 2020

Actual Primary Completion Date :

Nov 30, 2020

Actual Study Completion Date :

Apr 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ursolic Acid Administration of Ursolic Acid twice a day for 2 weeks	Drug: Ursolic Acid Ursolic Acid 150mg
Experimental: Curcumin Administration of Curcumin twice a day for 2 weeks	Drug: Curcumin Curcumin 600mg
Experimental: 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	Drug: Ursolic Acid Ursolic Acid 150mg Drug: Curcumin Curcumin 600mg

Arm

Intervention/Treatment

Experimental: Ursolic Acid

Administration of Ursolic Acid twice a day for 2 weeks

Drug: Ursolic Acid

Ursolic Acid 150mg

Experimental: Curcumin

Administration of Curcumin twice a day for 2 weeks

Drug: Curcumin

Curcumin 600mg

Experimental: 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

Drug: Ursolic Acid

Ursolic Acid 150mg

Drug: Curcumin

Curcumin 600mg

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator: Michael A Liss, MD, University of Texas Health at San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT04421716

Other Study ID Numbers:

HSC20190940H

First Posted:

Jun 9, 2020

Last Update Posted:

May 5, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ursolic acid

Curcumin

Study Results

No Results Posted as of May 5, 2021