NCT04596254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

October 15, 2020

Last Update Submit

June 20, 2023

Conditions

Healthy Diet

Outcome Measures

Primary Outcomes (1)

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

    Collection before and after juice intake

    7 days

Study Arms (1)

Juice Intake

OTHER
Other: Pomegranate Juice

Interventions

Pomegranate JuiceOTHER

Collection of Mother's milk before and after juice consumption

Juice Intake

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valleywise Health Biobank

Phoenix, Arizona, 85008, United States

Location

Study Officials

  • Anurag SIngh, MD, PhD

    Amazentis SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

October 15, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)