University of California, Davis
Davis, California, 95616, United States
NCT Number: NCT01817127
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 is active but is not currently recruiting participants.
Notify Me18 year–45 year
Female
Observational
Davis, California, 95616, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Day 2-Day 366 postpartum
Milk and infant stratum corneum will be analyzed by MS methods.
Time frame: Day 2-Day 366 postpartum
Milk and skin will be analyzed by gas chromatography and MS methods.
Time frame: 3rd trimester pregnancy and 2 months postpartum
The plasma lipid profile will be analyzed by enzyme assay by UC Davis Pathology Lab.
Time frame: 3rd trimester pregnancy and Day 2-Day 366
Milk and infant and maternal stool will be analyzed by MS methods.
Time frame: 3rd trimester of pregnancy and D2-Day 366
Milk, maternal and infant urine and stool will be analyzed by NMR spectroscopy.
Time frame: Day 2-Day 366 postpartum
Milk, maternal and infant urine and stool will be analyzed by MS.
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.
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.
Time frame: 3rd trimester of pregnancy and Day 60 postpartum
Plasma lipoprotein size distribution and concentration will be analyzed by NMR spectroscopy by LipoScience.
Time frame: 3 and 6 months postpartum
Milk samples will be preserved with RNA-later, RNA extracted and analyzed by next generation sequencing techniques.
Time frame: Days 2 through 50
Milk samples will be analyzed for alkaline phosphatase activity by fluorometric assay
University of California, Davis
Other
Functional Deconstruction of Human Milk Oligosaccharides and Lipids
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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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