UrolithPomXNCT02370641
Effects of Pomegranate Extract on Intestinal Flora
A study testing PomX in people with Urolith, run by University of California, Los Angeles.
Trial summary
A total of 20 individuals, 10 urolithin excretors and 10 nonexcretors will be enrolled. The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolith
- What is being tested?
- PomX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-50 years of age at screen.
- In good health
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Who cannot join
- Any history of gastrointestinal disease except for appendectomy
- Any use of antibiotics or laxatives during the 2 months prior to study enrollment.
- Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject consuming pre- or probiotics
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- Any subject who currently uses tobacco products or has used tobacco products within the last year.
- Any subject who is unable or unwilling to comply with the study protocol.
About this study
Official title: Variations in Urolithin Production by the Microbiome After Pomegranate Extract Administration: Understanding Metabolism and Responsiveness to Pomegranate Ellagitannins
A total of 20 individuals, 10 urolithin excretors and 10 nonexcretors will be enrolled. The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. Subjects will be asked to consume one capsule of 1000 mg POMx daily for 4 weeks. At day 28, a blood sample, 24 hour urine sample will be obtained, and the stool collected by the participant in the prior 24 hours will be returned to the Center. Blood and urine urolithin, ellagic acid levels and stool bacteria enumeration and identification (including pyrosequencing) will be measured with the samples collected. A stool DNA sample will be preserved and frozen for potential future measurement of gene-nutrient interaction in pomegranate metabolism.
Throughout the study participants will be instructed not to consume pomegranate products, walnuts, or polyphenol-rich fruits ((strawberry, raspberry etc) or juices drawn from a list used in prior studies. The study will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins. Participants will be recruited by advertisement in the local newspaper in the Los Angeles Area close to UCLA.
Read the detailed description
At screening, informed consent and health insurance portability and assurance (HIPAA) authorization will be reviewed and signed. A medical history will be obtained. If criteria for enrollment are satisfied, a fasting blood sample will be collected for a comprehensive metabolic panel, and blood count. Results will be reviewed by the study physician for compliance to inclusion and exclusion criteria. The screening visit will also include a review of foods to avoid during run-in and study participation. Once lab results from the screening visit come back and are determined to be satisfactory for inclusion, the subject will be called and instructed to start dietary restrictions. The first stool collection (Day -1) will occur after two weeks of dietary compliance.
Day -1: Subjects will be asked to collect an entire stool and store it in a cooler filled with ice packs, along with a collection container until delivery to the lab within 24 hours.
Day 1: Subjects will take the 1st dose of POMx and be given a container for collecting their urine for 24 hours and asked to refrigerate this as the urine is collected. This urine will be used to determine the presence of urolithin A and whether they are "responder or non responder". Participants will be asked to consume 1 POMx capsule daily and to abstain from consuming pomegranates, walnuts, or polyphenol-rich foods or juices drawn from a list.
Day 27: Subjects will collect one entire stool and place in the provided cooler filled with ice packs for storage of the stool sample until delivery to the lab within 24 h. Urine collection will start at 8am after the morning dose of POMx and last until 8 am the day of clinic visit.
Day 28: Stool and urine sample will be collected. The stool sample collected at home (within the prior 24 hours) will be returned on this day. Blood sample will be collected. Compliance will be assessed by pill count. Safety and tolerance data will be collected.
- Conditions
- Urolith
- Being tested
- PomX
- Keywords
- urolithin A, microflora
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomXDietary supplement
1000 mg POMx daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| urolithin excretors | Active comparator | The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. Receives: Dietary Supplement: PomX |
| non excretors | Active comparator | The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. Receives: Dietary Supplement: PomX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors
Difference of percentage of total microflora between urolithin excretors and non-excretors after consumption of pomegranate extract for 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, M.D., Ph.D., Principal investigator, UCLA Department of Medicine, Division of Clinical Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370641
- Sponsor's protocol ID
- 12-000874
- Acronym
- PomX
- Status last verified
- Sep 2019
- First submitted
- 18 Feb 2015
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD with other researchers.
Publications
Li Z, Henning SM, Lee RP, Lu QY, Summanen PH, Thames G, Corbett K, Downes J, Tseng CH, Finegold SM, Heber D. Pomegranate extract induces ellagitannin metabolite formation and changes stool microbiota in healthy volunteers. Food Funct. 2015 Aug;6(8):2487-95. doi: 10.1039/c5fo00669d. Epub 2015 Jul 20.
PubMed 26189645
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations in Urolithin Production by the Microbiome After Pomegranate Extract Administration: Understanding Metabolism and Responsiveness to Pomegranate Ellagitannins
- ClinicalTrials.gov ID
- NCT02370641
- Acronym / sponsor ID
- PomX / 12-000874
- Conditions
- Urolith
- Keywords
- urolithin A, microflora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 20 individuals, 10 urolithin excretors and 10 nonexcretors will be enrolled. The excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. Subjects will be asked to consume one capsule of 1000 mg POMx daily for 4 weeks. At day 28, a blood sample, 24 hour urine sample will be obtained, and the stool collected by the participant in the prior 24 hours will be returned to the Center. Blood and urine urolithin, ellagic acid levels and stool bacteria enumeration and identification (including pyrosequencing) will be measured with the samples collected. A stool DNA sample will be preserved and frozen for potential future measurement of gene-nutrient interaction in pomegranate metabolism.
Throughout the study participants will be instructed not to consume pomegranate products, walnuts, or polyphenol-rich fruits ((strawberry, raspberry etc) or juices drawn from a list used in prior studies. The study will be carried out in accordance with the guidelines of the Human Subjects Protection Committee of the University of California, Los Angeles. All subjects will give written informed consent before the study begins. Participants will be recruited by advertisement in the local newspaper in the Los Angeles Area close to UCLA.
Detailed description
At screening, informed consent and health insurance portability and assurance (HIPAA) authorization will be reviewed and signed. A medical history will be obtained. If criteria for enrollment are satisfied, a fasting blood sample will be collected for a comprehensive metabolic panel, and blood count. Results will be reviewed by the study physician for compliance to inclusion and exclusion criteria. The screening visit will also include a review of foods to avoid during run-in and study participation. Once lab results from the screening visit come back and are determined to be satisfactory for inclusion, the subject will be called and instructed to start dietary restrictions. The first stool collection (Day -1) will occur after two weeks of dietary compliance.
Day -1: Subjects will be asked to collect an entire stool and store it in a cooler filled with ice packs, along with a collection container until delivery to the lab within 24 hours.
Day 1: Subjects will take the 1st dose of POMx and be given a container for collecting their urine for 24 hours and asked to refrigerate this as the urine is collected. This urine will be used to determine the presence of urolithin A and whether they are "responder or non responder". Participants will be asked to consume 1 POMx capsule daily and to abstain from consuming pomegranates, walnuts, or polyphenol-rich foods or juices drawn from a list.
Day 27: Subjects will collect one entire stool and place in the provided cooler filled with ice packs for storage of the stool sample until delivery to the lab within 24 h. Urine collection will start at 8am after the morning dose of POMx and last until 8 am the day of clinic visit.
Day 28: Stool and urine sample will be collected. The stool sample collected at home (within the prior 24 hours) will be returned on this day. Blood sample will be collected. Compliance will be assessed by pill count. Safety and tolerance data will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urolithin excretors | Active comparator | Dietary Supplement: PomXThe excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. |
| non excretors | Active comparator | Dietary Supplement: PomXThe excretor status will be determined by analysis for urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample will be obtained before administering the extract. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-50 years of age at screen.
- In good health
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Key exclusion criteria (7 listed)
- Any history of gastrointestinal disease except for appendectomy
- Any use of antibiotics or laxatives during the 2 months prior to study enrollment.
- Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject consuming pre- or probiotics
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
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 |
|---|---|---|
| PomX1000 mg POMx daily for 4 weeks | Dietary supplement | non excretors, urolithin excretors |
Primary outcome
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors
Time frame: 4 weeks
Difference of percentage of total microflora between urolithin excretors and non-excretors after consumption of pomegranate extract for 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26189645Li Z, Henning SM, Lee RP, Lu QY, Summanen PH, Thames G, Corbett K, Downes J, Tseng CH, Finegold SM, Heber D. Pomegranate extract induces ellagitannin metabolite formation and changes stool microbiota in healthy volunteers. Food Funct. 2015 Aug;6(8):2487-95. doi: 10.1039/c5fo00669d. Epub 2015 Jul 20.
- Individual participant dataSharing planned: No. No plan to share IPD with other researchers.
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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.
Zhaoping Li, M.D., Ph.D. principal investigator
UCLA Department of Medicine, Division of Clinical Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing PomX in people with Urolith, run by University of California, Los Angeles.
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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370641, which also lists 1 linked publication.
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 2 Oct 2019.