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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PomX | Dietary Supplement | 1000 mg POMx daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, M.D., Ph.D. | UCLA Department of Medicine, Division of Clinical Nutrition | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26189645 | Result | 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. |
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No plan to share IPD with other researchers.
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Twenty-six healthy participants were enrolled in the study. There were two study phases including a 2-week run-in period and a 4-week intervention period. Six subjects who did not complete the study were excluded.
The enrollment period was 10/31/2012 - 7/2/2013. Enrollment took place in a private setting in the clinic located at the site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Urolithin Excretors | The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract. PomX: 1000 mg POMx daily for 4 weeks |
| FG001 | Non Excretors | The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract. PomX: 1000 mg POMx daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Urolithin Excretors | The excretor status was determined by analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract. PomX: 1000 mg POMx daily for 4 weeks |
| BG001 | Non Excretors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | percentage of total microflora | 4 weeks |
|
Adverse event data was collected over a 4 week period
Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microbial Phylum Abundance in Urolithin Excretors | microbial phylum abundance in urolithin excretors after consumption of 1000 mg pomegranate extract daily for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea after taking supplement on empty stomach | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhaoping Li, Professor | UCLA Department of Medicine/Center for Human Nutrition | 310-206-1987 | zli@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract. PomX: 1000 mg POMx daily for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
| EG001 | Microbial Phylum Abundance in Urolithin Non Excretors | The excretor status was determined by the analysis of urolithin A glucuronide in 24 hour urine after one dose of POMx. A blood sample and stool sample were obtained before administering the extract. PomX: 1000 mg POMx daily for 4 weeks | 0 | 6 | 1 | 6 |
| mild gastrointestinal discomfort after taking supplement on empty stomach | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
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| D052801 | Male Urogenital Diseases |