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

Active, not recruiting

• Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes Mellitus; Healthy

• Registration Number: NCT01817127
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04-01
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-22
• Primary Completion: 2015-02-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Completion: 2028-09-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 395

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Human milk glycans	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 Outcome Measures

Name	Time	Method
Peptidome	3rd trimester pregnancy and Day 2-Day 366	Milk and infant and maternal stool will be analyzed by MS methods.
Maternal plasma lipoprotein size distribution	3rd trimester of pregnancy and Day 60 postpartum	Plasma lipoprotein size distribution and concentration will be analyzed by NMR spectroscopy by LipoScience.
Maternal plasma lipids	3rd trimester pregnancy and 2 months postpartum	The plasma lipid profile will be analyzed by enzyme assay by UC Davis Pathology Lab.
Metabolome by Nuclear Magnetic Spectroscopy (NMR)	3rd trimester of pregnancy and D2-Day 366	Milk, maternal and infant urine and stool will be analyzed by NMR spectroscopy.
Secretor status genotyping	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.
Maternal fasting and postprandial blood sugar	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.
Human Milk Transcriptomics	3 and 6 months postpartum	Milk samples will be preserved with RNA-later, RNA extracted and analyzed by next generation sequencing techniques.
Microbiota	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.
Proteome	Day 2-Day 366 postpartum	Milk and infant stratum corneum will be analyzed by MS methods.
Lipidome	Day 2-Day 366 postpartum	Milk and skin will be analyzed by gas chromatography and MS methods.
Metabolome by MS	Day 2-Day 366 postpartum	Milk, maternal and infant urine and stool will be analyzed by MS.

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States