Clinical trial

Maternal Obesity, Breast Milk Composition, and Infant Growth

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03301753

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age0 Years to 45 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Pregnancy, Breastmilk Collection, Infant Overnutrition, Gestational Diabetes Mellitus (GDM)

Full registry criteria

Inclusion Criteria: * Pregnant females * 21 to 45 years of age at the time of delivery * Pre-gravid BMI between 18.5 to 40 kg/m2 * Healthy pregnancy defined as \<3 days in hospital following delivery * Report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3-months * If parity \>1, report that they successfully breast fed a previous pregnancy for at least 3 months * Singleton gestation * Term pregnancy (gestational age \>37 but \<42 weeks) * Infant birth weight \>2,500 grams but \<4,500 grams. Exclusion Criteria: * Alcohol consumption \>1 drink per week during pregnancy/lactation * Tobacco consumption during pregnancy/lactation * History/current Type I or II diabetes * Inability to speak/understand English * Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Milk Composition Changes1-3 months post-partum

Breastmilk hormone concentration changes

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of Minnesota School of Public Health🇺🇸 Minneapolis, Minnesota, United States

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University of Oklahoma Health Sciences Center🇺🇸 Oklahoma City, Oklahoma, United States

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