CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
PomXdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02370641
NCT02370641N/ACompleted

Variations in Urolithin Production by the Microbiome After Pomegranate Extract Administration: Understanding Metabolism and Responsiveness to Pomegranate Ellagitannins

University of California, Los Angeles·interventional·Posted Feb 25, 2015·Updated Oct 2, 2019

In Brief

A clinical study evaluating PomX for Urolith. Completed, enrolled 26 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrolith
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2015
Enrollment StartOct 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.4 years ago

Interventions

PomXdietary

1000 mg POMx daily for 4 weeks