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

University of California (UC) Davis

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT01817127

216198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 395 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

395 participants in 6 patient groups

Main Study

Description:

Women enrolled in this cohort of the study will collect their breast milk, infant urine and stool, and their urine and stool samples. Blood and saliva will be collected from these participants by study personnel.

Gestational Diabetes Mellitus Cohort

Description:

Women who have been diagnosed with gestational diabetes mellitus, type 2 diabetes mellitus or impaired glucose tolerance will be enrolled in this cohort. Participants will be asked to report their fasting and postprandial blood glucose levels if they are monitoring these outcomes at home with a glucometer.

Fresh Milk Cohort

Description:

Women enrolled in this cohort will provide fresh milk samples (stored in the refrigerator and picked up by study personnel within 1 hour of collection) for analysis of glycan composition and gene expression of glycan metabolizing enzymes of somatic cells in milk.

RNA Milk Fat Cohort

Description:

Women enrolled in this cohort must have given birth to sons and will collect a fresh milk sample for transcriptomic analysis compared against non-human primate milk.

Skin Study

Description:

This cohort includes mothers and their infants who will provide milk and infant stratum corneum cells to act as the control group for a different study designed to investigate skin function in premature infants.

BMMI Project

Description:

Subjects enrolled in this cohort will be part of the control group for the BMMI Project.