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NCT Number: NCT01817127

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Human milk glycans

    Time frame: Change from day 2 to day 366

    Human milk glycans: human milk oligosaccharides and glycoconjugates to lipids, proteins and peptides will be measured by MS methods.

Secondary outcomes

  1. Microbiota

    Time frame: 3rd trimester pregnancy and Day 2-Day 366 postpartum

    Maternal and infant gut microbiota, infant skin microbiota will be measured using next generation sequencing, terminal restriction fragment length polymorphism and quantitative polymerase chain reaction.

  2. Proteome

    Time frame: Day 2-Day 366 postpartum

    Milk and infant stratum corneum will be analyzed by MS methods.

  3. Lipidome

    Time frame: Day 2-Day 366 postpartum

    Milk and skin will be analyzed by gas chromatography and MS methods.

  4. Maternal plasma lipids

    Time frame: 3rd trimester pregnancy and 2 months postpartum

    The plasma lipid profile will be analyzed by enzyme assay by UC Davis Pathology Lab.

  5. Peptidome

    Time frame: 3rd trimester pregnancy and Day 2-Day 366

    Milk and infant and maternal stool will be analyzed by MS methods.

  6. Metabolome by Nuclear Magnetic Spectroscopy (NMR)

    Time frame: 3rd trimester of pregnancy and D2-Day 366

    Milk, maternal and infant urine and stool will be analyzed by NMR spectroscopy.

  7. Metabolome by MS

    Time frame: Day 2-Day 366 postpartum

    Milk, maternal and infant urine and stool will be analyzed by MS.

  8. Secretor status genotyping

    Time frame: 3rd trimester pregnancy and Day 60 postpartum

    Maternal secretor status genotyping will be determined by quantitative polymerase chain reaction for the functional fucosyltransferase 2 gene from maternal saliva.

  9. Maternal fasting and postprandial blood sugar

    Time frame: 3rd trimester of pregnancy and Day 3-7

    Maternal blood sugar will be checked by finger stick using a glucometer in women diagnosed with gestational diabetes mellitus.

  10. Maternal plasma lipoprotein size distribution

    Time frame: 3rd trimester of pregnancy and Day 60 postpartum

    Plasma lipoprotein size distribution and concentration will be analyzed by NMR spectroscopy by LipoScience.

  11. Human Milk Transcriptomics

    Time frame: 3 and 6 months postpartum

    Milk samples will be preserved with RNA-later, RNA extracted and analyzed by next generation sequencing techniques.

Other outcomes

  1. Alkaline phosphatase levels

    Time frame: Days 2 through 50

    Milk samples will be analyzed for alkaline phosphatase activity by fluorometric assay

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • California Dairy Research Foundation

Registry information

Official study title

Functional Deconstruction of Human Milk Oligosaccharides and Lipids

Important dates

Study start
2009
Primary completion
2015
Study completion
2028
First posted
Mar 22, 2013
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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