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NCT03522597 · ClinicalTrials.gov registry record

Metabolism, Breastmilk, and Microbiome

A clinical trial of Obesity and Diabetes, Gestational, sponsored by University of Minnesota.

Completed
Registry status
2,050
Enrollment target
1
Study location

NCT03522597: Completed study of Obesity and Diabetes, Gestational, sponsored by University of Minnesota.

NCT03522597 is a study of Obesity and Diabetes, Gestational that has completed, run by University of Minnesota. The registered enrollment target is 2,050 participants, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (151% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03522597, a study of Obesity and Diabetes, Gestational, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
2,050 participants
Enrollment target
1
Study location

Study Summary

The objective of this pilot study is to compare breast milk composition in mothers of three different metabolic states (normal weight, obese, and gestational diabetic) and to determine the extent to which breastmilk components are transmitted to the infant gut and are associated with the anthropometric and body composition changes in their infants during the first 6 months of life. It is hypothesized that 1) different maternal metabolic states will be associated with differences in breastmilk microbial communities and breastmilk biochemical features, 2) differences in these breastmilk biomarkers will be transmitted to infants and 3) breastmilk microbial and metabolic features will be associated with infant growth outcomes.

Primary Outcome

Change in the diversity and abundance of breast milk and infant gut bacterial and fungal species and strains, and functional microbiome profiles

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 2,050 participants
Start Date 2018-06-01
Est. Completion 2025-07-01
University of Minnesota

966 total trials

What the finished NCT03522597 record still lists

NCT03522597 is an observational study that tracks outcomes without assigning an intervention. Its 2,050 participants enrollment target places it among the larger protocols in the corpus, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (151% higher).

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.

NCT03522597 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT03522597 about?

NCT03522597 is a clinical study titled "Metabolism, Breastmilk, and Microbiome". The objective of this pilot study is to compare breast milk composition in mothers of three different metabolic states (normal weight, obese, and gestational diabetic) and to determine the extent to which breastmilk components are transmitted to the infant gut and are associated with the anthropomet...

What is the current status of trial NCT03522597?

This trial is currently completed. The enrollment target is 2,050 participants. The study started on 2018-06-01. Estimated completion is 2025-07-01.

What conditions does trial NCT03522597 study?

This clinical trial studies the following conditions: Obesity, Diabetes, Gestational.

Who is sponsoring clinical trial NCT03522597?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03522597 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03522597's enrollment target sits among peer trials

2,050 42nd of 1053 higher than 1,011 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03522597, the US trial registry maintained by the National Library of Medicine. NCT03522597 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.