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

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ClinicalTrials.gov Identifier: NCT01817127
Recruitment Status : Active, not recruiting
First Posted : March 22, 2013
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
California Dairy Research Foundation
Information provided by (Responsible Party):
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.

Condition or disease
Healthy Gestational Diabetes Mellitus Type 2 Diabetes Mellitus

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.


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Study Type : Observational
Actual Enrollment : 395 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Main Study
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.
Skin Study
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
Subjects enrolled in this cohort will be part of the control group for the BMMI Project.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. 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
Breast milk, blood, saliva, urine, stool, epidermal skin cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women and women diagnosed with gestational diabetes mellitus or type 2 diabetes mellitus.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
California Dairy Research Foundation
Investigators
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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

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01817127     History of Changes
Other Study ID Numbers: 216198
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications