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Completed

NCT Number: NCT04421716

Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid

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.

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Key information

Conditions

Bioavailability of Phytonutrients

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ursolic Acid

Drug

Ursolic Acid 150mg

curcumin

Drug

Curcumin 600mg

Primary outcomes

  1. Number, frequency, duration, and relation of toxicity events

    Time frame: 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.

  2. Peak serum concentration

    Time frame: 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.

  3. Time to reach peak serum concentration

    Time frame: 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.

  4. Half-life

    Time frame: Baseline to 2 weeks

    The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.

Secondary outcomes

  1. Microbiome Alpha Diversity

    Time frame: Baseline to 2 weeks

    Number of bacteria collected from rectal culture sample will be assessed before and after each exposure

  2. Microbiome Beta Diversity

    Time frame: Baseline to 2 weeks

    Proportions of bacteria collected from rectal culture sample will be assessed before and after each exposure

  3. Metabolite Panels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.