Bioavailability of PhytonutrientsEarly Phase 1NCT04421716
Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid
A Early Phase 1 study testing Ursolic Acid and Curcumin in people with Bioavailability of Phytonutrients, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Phytonutrients
- What is being tested?
- Ursolic Acid and Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 16 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give informed consent
- Be men age 18 or older
- Able to stop supplements
Who cannot join
- Unable to give informed consent
- Age < 18
- Woman
- Prisoners
- Diagnosed cancer
- Unable to swallow pills
- Unable to stop supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Phase I Clinical Trial 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.
Read the 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
- Being tested
- Ursolic Acid, Curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursolic AcidDrug
Ursolic Acid 150mg
CurcuminDrug
Curcumin 600mg
| Study group | Role | What they receive |
|---|---|---|
| Ursolic Acid | Experimental | Administration of Ursolic Acid twice a day for 2 weeks Receives: Drug: Ursolic Acid |
| Curcumin | Experimental | Administration of Curcumin twice a day for 2 weeks Receives: Drug: Curcumin |
| Ursolic Acid and Curcumin | Experimental | 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 Receives: Drug: Ursolic Acid; Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 weeks
Peak serum concentration
Dose response curve representing the pharmacokinetic parameter peak serum concentration (Cmax) of ursolic acid, curcumin, and their metabolites will be graphed.
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
Half-life
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
Measured: Baseline to 2 weeks
Secondary outcomes (3)
Microbiome Alpha Diversity
Number of bacteria collected from rectal culture sample will be assessed before and after each exposure
Measured: Baseline to 2 weeks
Microbiome Beta Diversity
Proportions of bacteria collected from rectal culture sample will be assessed before and after each exposure
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 Oct 2020
- Primary completion30 Nov 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of PhytonutrientsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Liss, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421716
- Sponsor's protocol ID
- HSC20190940H
- Status last verified
- May 2021
- First submitted
- 21 May 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial Testing the Bioavailability of Phytonutrients, Curcumin and Ursolic Acid
- ClinicalTrials.gov ID
- NCT04421716
- Acronym / sponsor ID
- HSC20190940H
- Conditions
- Bioavailability of Phytonutrients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ursolic Acid | Experimental | Drug: Ursolic AcidAdministration of Ursolic Acid twice a day for 2 weeks |
| Curcumin | Experimental | Drug: CurcuminAdministration of Curcumin twice a day for 2 weeks |
| Ursolic Acid and Curcumin | Experimental | Drug: Ursolic Acid, Drug: CurcuminAdministration 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be able to give informed consent
- Be men age 18 or older
- Able to stop supplements
Key exclusion criteria (7 listed)
- Unable to give informed consent
- Age < 18
- Woman
- Prisoners
- Diagnosed cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursolic AcidUrsolic Acid 150mg | Drug | Ursolic Acid, Ursolic Acid and Curcumin |
| CurcuminCurcumin 600mg | Drug | Curcumin, Ursolic Acid and Curcumin |
Primary outcome
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.
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.
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.
Half-life
Time frame: Baseline to 2 weeks
The pharmacokinetic parameter, half-life of ursolic acid, curcumin, and their metabolites will be graphed.
3 secondary outcomes
Microbiome Alpha Diversity
Time frame: Baseline to 2 weeks
Microbiome Beta Diversity
Time frame: Baseline to 2 weeks
Metabolite Panels
Time frame: Baseline to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Liss, MD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ursolic Acid and Curcumin in people with Bioavailability of Phytonutrients, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number, frequency, duration, and relation of toxicity events (time frame: Baseline to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.