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

Prospective Human Specimen Collection for Medical Research

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04596254
Enrollment
7
Registered
2020-10-22
Start date
2020-10-15
Completion date
2022-12-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Diet

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.

Interventions

OTHERPomegranate Juice

Collection of Mother's milk before and after juice consumption

Sponsors

Amazentis SA
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in levels of gut metabolites in breast milk following juice intake7 daysCollection before and after juice intake

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026