Summary

for females ages 18-45 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion
Bruce German(ucdavis)Carlito Lebrilla, PhD(ucdavis)David Mills(ucdavis)Bart Weimer, PhD(ucdavis)Xiangdong Wu(ucdavis)Helen Raybould, PhD(ucdavis)Danielle Lemay(ucdavis)

Description

Summary

This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.

Official Title

Functional Deconstruction of Human Milk Oligosaccharides and Lipids

Details

This study's objectives include: 1) develop a better understanding of the composition and structures of breast milk over the early stages of lactation with specific emphasis on the glycans and lipids; 2) how glycan diversity relates to maternal and infant gut microbiota with an emphasis on bifidobacteria species; 3)how milk composition and structure relate to maternal health and diet.

These samples will be analyzed using comprehensive gas and liquid chromatographic methods, nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS); and next generation sequencing, terminal restriction fragment length polymorphism and quantitative polymerase chain reaction.

There are several cohorts to the main study.

Gestational Diabetes Mellitus Cohort. The aim of this study is to investigate the differences between milk composition, infant and maternal gut microbiota from women with and without gestational diabetes mellitus or type 2 diabetes vs. controls.

Fresh Milk Study. The aim of this study is to elucidate the relationship between the expression of glycan metabolizing genes of mammary epithelial cells and levels of milk glycans.

RNA Study. The aim of this study is to compare the RNA of milk fat globule membrane crescents in human milk against epithelial expression profiles in non-human primate milk.

Skin Study. The aim of this study is to provide skin samples from healthy term infants to act as the control group for a different study with preterm infants.

Breast Milk, Gut Microbiome, and Immunity (BMMI) Project. The aim of this study is to provide healthy control samples for the BMMI project. The BMMI project is a multi-investigative project designed to elucidate how maternal nutrient status, and milk composition and structure influence infant gut microbiome from participants in developing countries.

Keywords

Healthy Gestational Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes, Gestational Diabetes Mellitus Skin Study BMMI Project

Eligibility

You can join if…

Open to females ages 18-45

  • Pregnant women 18 years and older who plan to breastfeed for at least 6 months
  • Women who are in good health
  • Women with or without diagnosis of gestational diabetes mellitus, or type 2 diabetes mellitus or impaired glucose tolerance

You CAN'T join if...

  • Women who do not plan to breastfeed for at least 6 months
  • Women who give birth to pre-term infants
  • Women who smoke, either currently or 1 year before becoming pregnant
  • Women who have chronic medical conditions or communicable diseases
  • Women who take metabolic altering drugs such as corticosteroids or thyroid medication

Location

  • University of California, Davis
    Davis California 95616 United States

Lead Scientists

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Details for this research project is available through the UC Davis Foods for Health Institute website
ID
NCT01817127
Study Type
Observational
Last Updated