Detection of Gut Metabolites in Mother's Milk Following Juice Intake

Prospective Human Specimen Collection for Medical Research

The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.

Study Overview

• Status: Completed
• Conditions: Healthy Diet
• Intervention / Treatment: Other: Pomegranate Juice

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Valleywise Health Biobank

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 20-40 yrs. female subjects with no lactation problems
• Healthy and term delivery
• Healthy dietary intake (vegetarian or omnivore)
• Agree to donate breast milk (not colostrum)
• First 6 months of lactation
• Subjects agree to consumer 8oz. of pomegranate juice for a week prior to 2nd collection

Exclusion Criteria:

• <20 yrs or >40 yrs. of age
• Subjects with lactation problems
• Preterm delivery
• Colostrum samples
• Lactation>6 months
• Subjects fail to drink juice for at least a week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Juice Intake	Other: Pomegranate Juice; Collection of Mother's milk before and after juice consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in levels of gut metabolites in breast milk following juice intake	Collection before and after juice intake	7 days

Collaborators and Investigators

• Sponsor: Amazentis SA
• Investigators: Study Director: Anurag SIngh, MD, PhD, Amazentis SA

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20.01.AMZ_BIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No