Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study



Status:Active, not recruiting
Conditions:Healthy Studies, Diabetes
Therapuetic Areas:Endocrinology, Other
Healthy:No
Age Range:18 - 45
Updated:12/26/2018
Start Date:April 2009
End Date:October 29, 2023

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Functional Deconstruction of Human Milk Oligosaccharides and Lipids

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
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Davis, California 95616
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Davis, CA
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