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

NCT04341961 | Completed

• 1 other identifier: 18-001683
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

microbiome; pomegranate; breastmilk

Outcome Measures

Primary Outcomes (3)

• Pomegranate Juice Metabolism

  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.

  2 weeks

• Microbiome

  To determine whether pomegranate metabolites are bioavailable to breastfed infants by analyzing ellagic acid in urine and stool from infants of mothers consuming PJ.

  2 weeks

• Microbiome

  To determine whether pomegranate metabolites are bioavailable to breastfed infants by analyzing urolithin in urine and stool from infants of mothers consuming PJ.

  2 weeks

Study Arms (1)

Pom Juice

EXPERIMENTAL

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).

Other: Pomegranate Juice

Interventions

Pomegranate Juice OTHER

Drinking 8 oz of pomegranate juice daily for 2 weeks.

Pom Juice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Zhaoping Li, MD

  UCLA Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: May 8, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)