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Clinical Trials/NCT04596254
NCT04596254CompletedNot Applicable

Prospective Human Specimen Collection for Medical Research

Amazentis SA2 sites in 1 country7 target enrollmentStarted: October 15, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Change in levels of gut metabolites in breast milk following juice intake
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

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

Time Frame: 7 days

Collection before and after juice intake

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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