Maternal Obesity, Breast Milk Composition, and Infant Growth (NCT03301753)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Minnesota School of Public Health — Minneapolis, Minnesota
Age range: 0 Years to 45 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Minnesota School of Public Health — Minneapolis, Minnesota
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.