Effect of Pomegranate Juice Consumption on the Health of Mothers and Infants During Breastfeeding (PomInfant)

• ClinicalTrials.gov Identifier: NCT04341961
• Recruitment Status: Completed
• First Posted: April 10, 2020
• Last Update Posted: August 4, 2020
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Zhaoping Li, University of California, Los Angeles

Tracking Information

• First Submitted Date: April 7, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: August 4, 2020
• Actual Study Start Date: May 8, 2019
• Actual Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2020)

• Pomegranate Juice Metabolism [ Time Frame: 2 weeks ]
  To examine the metabolism of pomegranate by analyzing blood, urine, breast milk and stool samples for ellagic acid and urolithin levels before and after administration of pomegranate extract for 2 weeks during breastfeeding in healthy mothers.
• Microbiome [ Time Frame: 2 weeks ]
  To determine whether pomegranate metabolites are bioavailable to breastfed infants by analyzing ellagic acid in urine and stool from infants of mothers consuming PJ.
• Microbiome [ Time Frame: 2 weeks ]
  To determine whether pomegranate metabolites are bioavailable to breastfed infants by analyzing urolithin in urine and stool from infants of mothers consuming PJ.

Original Primary Outcome Measures (submitted: April 7, 2020)

• Pomegranate Juice Metabolism [ Time Frame: 2 weeks ]
  To examine the metabolism of pomegranate by analyzing blood, urine, breast milk and stool samples for ellagic acid and urolithin levels before and after administration of pomegranate extract for 2 weeks during breastfeeding in healthy mothers.
• Microbiome [ Time Frame: 2 weeks ]
  To determine whether pomegranate metabolites are bioavailable to breastfed infants by analyzing ellagic acid and urolithin in urine and stool from infants of mothers consuming PJ.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Pomegranate Juice Consumption on the Health of Mothers and Infants During Breastfeeding
• Official Title: Observational Pilot Study on Pomegranate Metabolism in Breastfeeding Women and Their Infants
• Brief Summary: Breast milk is universally recognized as the best food for newborns. Studies have scientifically shown that breastfeeding provides optimal nutrients for infants, strengthens their immune system, and improves mother-and-child bonding. Demonstrating health benefits of pomegranate consumption on infant health could lead to greater incentive for women to breast feed. The purpose of this research study is to determine whether pomegranate metabolites (products produced by breakdown) is secreted into breastmilk and whether they have an effect on breast-fed infants who are born vaginally.
• Detailed Description: The study will require participants to continue with their usual diet and to avoid pomegranate juice (other than what is provided), berries (strawberries, blackberries, raspberries (red, black, yellow), cranberries), walnuts, pecans, hazelnuts, pecans, chestnuts, red and white guava, pomegranates, flaxseeds, dark chocolate and cocoa, coffee, tea, rose hip, olives, artichoke, dried herbs and beefsteak tongue mushrooms) . They will be asked to consume the pomegranate juice daily for 14 days. The pomegranate juice will be provided to participants. If the participants are unable to complete the study on the 14th day they will be asked to continue drinking the juice until they are able to complete the visit. For instance if day 14 falls on a Friday and they cannot come in until Monday participants will be asked to continue drinking the juice until Monday. Participants will be asked to collect 10ml (or 2 tsp) of breast milk; the collection materials will be provided, and participant will need to store the specimen in their home refrigerator and dropped off to the study site within 18-24 hours of the collection time. Participants will also be instructed to collect their stool and will be provided with the sterile collection materials and instructions for collection. Participants will be provided with a disposable cooler and ice packs to keep the specimen refrigerated during transport. Participants will also be provided with a urine collection container and asked to collect all of your urine over a 24-hour period (on 2 separate occasions). Lastly, infant stool and urine will also be collected using collection bags with an adhesive strip.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Breastfeeding

Intervention

Other: Pomegranate Juice

Drinking 8 oz of pomegranate juice daily for 2 weeks.

Study Arms

Experimental: Pom Juice

The study participants will all be asked to drink pomegranate juice for 2 weeks, and 4 weeks of continued usual diet and avoid pomegranate juice (other than what is given to you), berries (strawberries, blackberries, raspberries (red, black, yellow), cranberries), walnuts, pecans, hazelnuts, pecans, chestnuts, red and white guava, pomegranates, flaxseeds, dark chocolate and cocoa, coffee, tea, rose hip, olives, artichoke, dried herbs and beefsteak tongue mushrooms).

Intervention: Other: Pomegranate Juice

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 3, 2020): 11
• Original Estimated Enrollment (submitted: April 7, 2020): 12
• Actual Study Completion Date: July 31, 2020
• Actual Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• Postpartum 6 months with full term baby born vaginally and exclusively breast feeding
• 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

• No antibiotics or laxatives use during the 2 months before the study.
• Any subject consuming pre- or probiotics or anti-inflammatory medication
• 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 is unable or unwilling to comply with the study protocol.
• Allergic to pomegranate

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04341961
• Other Study ID Numbers: 18-001683
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Zhaoping Li, University of California, Los Angeles
• Original Responsible Party: Zhaoping Li, University of California, Los Angeles, Chief / Professor of Medicine
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Zhaoping Li, MD; UCLA Professor of Medicine

• PRS Account: University of California, Los Angeles
• Verification Date: August 2020