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

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.

Completed

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Key information

Conditions

Healthy Diet

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Valleywise Health Biobank

Phoenix, Arizona, 85008, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pomegranate juice

Other

Collection of Mother's milk before and after juice consumption

Primary outcomes

Change in levels of gut metabolites in breast milk following juice intake

Time frame: 7 days

Collection before and after juice intake

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Registry information

Official study title

Prospective Human Specimen Collection for Medical Research

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 22, 2020
Registry last updated: Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed