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

NCT ID: NCT04596254

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Healthy Diet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Juice Intake

Group Type OTHER

Pomegranate Juice

Intervention Type OTHER

Collection of Mother's milk before and after juice consumption

Interventions

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Pomegranate Juice

Collection of Mother's milk before and after juice consumption

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amazentis SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anurag SIngh, MD, PhD

Role: STUDY_DIRECTOR

Amazentis SA

Locations

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Valleywise Health Biobank

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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20.01.AMZ_BIO

Identifier Type: -

Identifier Source: org_study_id

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