Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

Bioavailability of Phytonutrients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421716
• Other study ID #: HSC20190940H
• Status: Completed
• Phase: Early Phase 1
• Start date: October 20, 2020
• Est. completion date: April 16, 2021

Study information

• Verified date: May 2021
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 16, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability of Phytonutrients

Intervention

Drug:
• Ursolic Acid
Ursolic Acid 150mg
• Curcumin
Curcumin 600mg

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, frequency, duration, and relation of toxicity events	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.	Baseline to 2 weeks
Primary	Peak serum concentration	Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.	Baseline to 2 weeks
Primary	Time to reach peak serum concentration	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.	Baseline to 2 weeks
Primary	Half-life	The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.	Baseline to 2 weeks
Secondary	Microbiome Alpha Diversity	Number of bacteria collected from rectal culture sample will be assessed before and after each exposure	Baseline to 2 weeks
Secondary	Microbiome Beta Diversity	Proportions of bacteria collected from rectal culture sample will be assessed before and after each exposure	Baseline to 2 weeks
Secondary	Metabolite Panels	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.	Baseline to 2 weeks