Observational Pilot Study on Pomegranate Metabolism in Breastfeeding Women and Their Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breastfeeding
- Sponsor
- University of California, Los Angeles
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Pomegranate Juice Metabolism
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Zhaoping Li
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 urolithin in urine and stool from infants of mothers consuming PJ.