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

Not Applicable

Completed

• Conditions: Healthy Diet
• Interventions: Other: Pomegranate Juice

• Registration Number: NCT04596254
• Lead Sponsor: Amazentis SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Juice Intake	Pomegranate Juice	-

Primary Outcome Measures

Name	Time	Method
Change in levels of gut metabolites in breast milk following juice intake	7 days	Collection before and after juice intake

Trial Locations

Locations (1)

Valleywise Health Biobank; 🇺🇸 Phoenix, Arizona, United States