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NCT03301753 · ClinicalTrials.gov registry record

Maternal Obesity, Breast Milk Composition, and Infant Growth

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

Active
Registry status
2,050
Enrollment target
2
Study locations

NCT03301753 is a study of Obesity and Pregnancy that is active but no longer recruiting, 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 2 study locations across 2 states.

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The verdict

NCT03301753, a study of Obesity and Pregnancy, is active but no longer recruiting, sponsored by University of Minnesota.

ACTIVE NOT RECRUITING
Registry status
2,050 participants
Enrollment target
2
Study locations

Study Summary

Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform among women, having been optimized through evolutionary time to provide adequate sole nutrition for the growing infant regardless of the environmental circumstances. However, recent evidence shows that breast milk is a highly complex fluid with significant inter-individual variation in hormonal and cytokine concentrations, human milk oligosaccharides (HMOs) and other features. Pervasive maternal obesity and gestational diabetes are evolutionarily novel conditions for the human species but little effort has yet been made to systematically examine how they are associated with breast milk adipose-tissue derived hormone and cytokine (adipocytokine) variation, HMOs, or other features, or whether that variation relates to infant metabolic status. The objective of this study is to comprehensively assess the "lactational programming" hypothesis, that is, whether or not recently documented variation in breast-milk composition is related to both maternal and infant metabolic status. The central hypothesis is that a graded, dose-response relationship between maternal adiposity and GDM exists with adipocytokine concentrations, HMOs, and other features in breast milk and that the milk concentrations of these features are associated with altered body composition in their exclusively breast-fed offspring. The results of the study will be used to design interventions to reduce maternal weight during pregnancy and lactation and to augment lactation education materials to focus on the needs of breastfeeding women with obesity and GDM.

Study Locations (2)

Minnesota

  • University of Minnesota School of Public Health - Minneapolis

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 2,050 participants
Start Date 2014-07-01
Est. Completion 2026-12-31

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT03301753

The ClinicalTrials.gov registry entry for NCT03301753 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 2,050 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (151% higher). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.

NCT03301753 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Oklahoma.

Frequently Asked Questions

What is clinical trial NCT03301753 about?

NCT03301753 is a clinical study titled "Maternal Obesity, Breast Milk Composition, and Infant Growth". Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform ...

What is the current status of trial NCT03301753?

This trial is currently active not recruiting. The enrollment target is 2,050 participants. The study started on 2014-07-01. Estimated completion is 2026-12-31.

What conditions does trial NCT03301753 study?

This clinical trial studies the following conditions: Obesity, Pregnancy, Gestational Diabetes Mellitus (GDM), Infant Overnutrition, Breastmilk Collection.

Who is sponsoring clinical trial NCT03301753?

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

Where is trial NCT03301753 being conducted?

This trial has 2 study locations across Minnesota, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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