Effects of Pomegranate Extract on Intestinal Flora
Condition: Urolith
Study type: Interventional

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.
    

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.
    

Intervention name(s): PomX
Intervention type(s): Dietary Supplement
Intervention description(s): 1000 mg POMx daily for 4 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: urolithin A; microflora