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NCT04596254 Clinical Trial

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

Healthy Diet Clinical Trial

Official title:
Prospective Human Specimen Collection for Medical Research

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04596254
Other study ID # 20.01.AMZ_BIO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date December 31, 2022

Study information
Verified date June 2023
Source Amazentis SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Pomegranate Juice
Collection of Mother's milk before and after juice consumption

Locations
Country Name City State
United States Valleywise Health Biobank Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Amazentis SA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in levels of gut metabolites in breast milk following juice intake Collection before and after juice intake 7 days
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