Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01817127|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2013
Last Update Posted : December 24, 2018
|Condition or disease|
|Healthy Gestational Diabetes Mellitus Type 2 Diabetes Mellitus|
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 Type :||Observational|
|Actual Enrollment :||395 participants|
|Official Title:||Functional Deconstruction of Human Milk Oligosaccharides and Lipids|
|Actual Study Start Date :||April 2009|
|Estimated Primary Completion Date :||October 29, 2023|
|Estimated Study Completion Date :||October 29, 2023|
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
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
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
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.
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.
Subjects enrolled in this cohort will be part of the control group for the BMMI Project.
- 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.
- 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.
- Proteome [ Time Frame: Day 2-Day 366 postpartum ]Milk and infant stratum corneum will be analyzed by MS methods.
- Lipidome [ Time Frame: Day 2-Day 366 postpartum ]Milk and skin will be analyzed by gas chromatography and MS methods.
- 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.
- Peptidome [ Time Frame: 3rd trimester pregnancy and Day 2-Day 366 ]Milk and infant and maternal stool will be analyzed by MS methods.
- 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.
- Metabolome by MS [ Time Frame: Day 2-Day 366 postpartum ]Milk, maternal and infant urine and stool will be analyzed by MS.
- 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.
- 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.
- 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.
- 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.
- Alkaline phosphatase levels [ Time Frame: Days 2 through 50 ]Milk samples will be analyzed for alkaline phosphatase activity by fluorometric assay
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817127
|United States, California|
|University of California, Davis|
|Davis, California, United States, 95616|
|Principal Investigator:||Bruce German, PhD||University of California, Davis|
|Principal Investigator:||Carlito Lebrilla, PhD||University of California, Davis|
|Principal Investigator:||David Mills, PhD||University of California, Davis|
|Principal Investigator:||Bart Weimer, PhD||University of California, Davis|
|Principal Investigator:||Xiangdong Wu, PhD||University of California, Davis|
|Principal Investigator:||Helen Raybould, PhD||University of California, Davis|
|Principal Investigator:||Jennifer T. Smilowitz, PhD||University of California, Davis|
|Principal Investigator:||Danielle Lemay, PhD||University of California, Davis|