N/A
Completed N=26
Effects of Pomegranate Extract on Intestinal Flora
Urolith
Source: ClinicalTrials.gov NCT02370641 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors — 60; 68; 56; 70 percentage of total microflora — p=0.012
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors |
60; 68; 56; 70; 3.4; 2.5 | 0.012 sig |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02370641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.