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

November 27, 2023 updated by: University of California, Davis

Functional Deconstruction of Human Milk Oligosaccharides and Lipids

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

395

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from day 2 to day 366

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3rd trimester pregnancy and Day 2-Day 366 postpartum
Proteome
Time Frame: Day 2-Day 366 postpartum
Milk and infant stratum corneum will be analyzed by MS methods.
Day 2-Day 366 postpartum
Lipidome
Time Frame: Day 2-Day 366 postpartum
Milk and skin will be analyzed by gas chromatography and MS methods.
Day 2-Day 366 postpartum
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.
3rd trimester pregnancy and 2 months postpartum
Peptidome
Time Frame: 3rd trimester pregnancy and Day 2-Day 366
Milk and infant and maternal stool will be analyzed by MS methods.
3rd trimester pregnancy and Day 2-Day 366
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.
3rd trimester of pregnancy and D2-Day 366
Metabolome by MS
Time Frame: Day 2-Day 366 postpartum
Milk, maternal and infant urine and stool will be analyzed by MS.
Day 2-Day 366 postpartum
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.
3rd trimester pregnancy and Day 60 postpartum
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.
3rd trimester of pregnancy and Day 3-7
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.
3rd trimester of pregnancy and Day 60 postpartum
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.
3 and 6 months postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alkaline phosphatase levels
Time Frame: Days 2 through 50
Milk samples will be analyzed for alkaline phosphatase activity by fluorometric assay
Days 2 through 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

California Dairy Research Foundation

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2009

Primary Completion (Actual)

February 28, 2015

Study Completion (Estimated)

September 4, 2028

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimated)

March 22, 2013

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe