HealthyNCT01817127
Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study
An observational study of Healthy and Gestational Diabetes Mellitus, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 4 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women and women diagnosed with gestational diabetes mellitus or type 2 diabetes mellitus.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Human milk glycans
Human milk glycans: human milk oligosaccharides and glycoconjugates to lipids, proteins and peptides will be measured by MS methods.
Measured: Change from day 2 to day 366
Secondary outcomes (11)
Microbiota
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.
Measured: 3rd trimester pregnancy and Day 2-Day 366 postpartum
Proteome
Milk and infant stratum corneum will be analyzed by MS methods.
Measured: Day 2-Day 366 postpartum
Lipidome
Milk and skin will be analyzed by gas chromatography and MS methods.
Measured: Day 2-Day 366 postpartum
Maternal plasma lipids
The plasma lipid profile will be analyzed by enzyme assay by UC Davis Pathology Lab.
Measured: 3rd trimester pregnancy and 2 months postpartum
Peptidome
Milk and infant and maternal stool will be analyzed by MS methods.
Measured: 3rd trimester pregnancy and Day 2-Day 366
Metabolome by Nuclear Magnetic Spectroscopy (NMR)
Milk, maternal and infant urine and stool will be analyzed by NMR spectroscopy.
Measured: 3rd trimester of pregnancy and D2-Day 366
Metabolome by MS
Milk, maternal and infant urine and stool will be analyzed by MS.
Measured: Day 2-Day 366 postpartum
Secretor status genotyping
Maternal secretor status genotyping will be determined by quantitative polymerase chain reaction for the functional fucosyltransferase 2 gene from maternal saliva.
Measured: 3rd trimester pregnancy and Day 60 postpartum
Maternal fasting and postprandial blood sugar
Maternal blood sugar will be checked by finger stick using a glucometer in women diagnosed with gestational diabetes mellitus.
Measured: 3rd trimester of pregnancy and Day 3-7
Maternal plasma lipoprotein size distribution
Plasma lipoprotein size distribution and concentration will be analyzed by NMR spectroscopy by LipoScience.
Measured: 3rd trimester of pregnancy and Day 60 postpartum
Human Milk Transcriptomics
Milk samples will be preserved with RNA-later, RNA extracted and analyzed by next generation sequencing techniques.
Measured: 3 and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study start1 Apr 2009
- Primary completion28 Feb 2015
- Study completion4 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Dairy Research Foundation
- Responsible party
- Sponsor
- Investigators
- Bruce German, PhD, Principal investigator, University of California, DavisCarlito Lebrilla, PhD, Principal investigator, University of California, DavisDavid Mills, PhD, Principal investigator, University of California, DavisBart Weimer, PhD, Principal investigator, University of California, DavisXiangdong Wu, PhD, Principal investigator, University of California, DavisHelen Raybould, PhD, Principal investigator, University of California, DavisJennifer T. Smilowitz, PhD, Principal investigator, University of California, DavisDanielle Lemay, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817127
- Sponsor's protocol ID
- 216198
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2013
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Totten SM, Zivkovic AM, Wu S, Ngyuen U, Freeman SL, Ruhaak LR, Darboe MK, German JB, Prentice AM, Lebrilla CB. Comprehensive profiles of human milk oligosaccharides yield highly sensitive and specific markers for determining secretor status in lactating mothers. J Proteome Res. 2012 Dec 7;11(12):6124-33. doi: 10.1021/pr300769g. Epub 2012 Nov 19.
PubMed 23140396De Leoz ML, Gaerlan SC, Strum JS, Dimapasoc LM, Mirmiran M, Tancredi DJ, Smilowitz JT, Kalanetra KM, Mills DA, German JB, Lebrilla CB, Underwood MA. Lacto-N-tetraose, fucosylation, and secretor status are highly variable in human milk oligosaccharides from women delivering preterm. J Proteome Res. 2012 Sep 7;11(9):4662-72. doi: 10.1021/pr3004979. Epub 2012 Aug 28.
PubMed 22900748Neville MC, Anderson SM, McManaman JL, Badger TM, Bunik M, Contractor N, Crume T, Dabelea D, Donovan SM, Forman N, Frank DN, Friedman JE, German JB, Goldman A, Hadsell D, Hambidge M, Hinde K, Horseman ND, Hovey RC, Janoff E, Krebs NF, Lebrilla CB, Lemay DG, MacLean PS, Meier P, Morrow AL, Neu J, Nommsen-Rivers LA, Raiten DJ, Rijnkels M, Seewaldt V, Shur BD, VanHouten J, Williamson P. Lactation and neonatal nutrition: defining and refining the critical questions. J Mammary Gland Biol Neoplasia. 2012 Jun;17(2):167-88. doi: 10.1007/s10911-012-9261-5. Epub 2012 Jul 1.
PubMed 22752723Garrido D, Nwosu C, Ruiz-Moyano S, Aldredge D, German JB, Lebrilla CB, Mills DA. Endo-beta-N-acetylglucosaminidases from infant gut-associated bifidobacteria release complex N-glycans from human milk glycoproteins. Mol Cell Proteomics. 2012 Sep;11(9):775-85. doi: 10.1074/mcp.M112.018119. Epub 2012 Jun 27.
PubMed 22745059Sela DA, Garrido D, Lerno L, Wu S, Tan K, Eom HJ, Joachimiak A, Lebrilla CB, Mills DA. Bifidobacterium longum subsp. infantis ATCC 15697 alpha-fucosidases are active on fucosylated human milk oligosaccharides. Appl Environ Microbiol. 2012 Feb;78(3):795-803. doi: 10.1128/AEM.06762-11. Epub 2011 Dec 2.
PubMed 22138995Marcobal A, Barboza M, Sonnenburg ED, Pudlo N, Martens EC, Desai P, Lebrilla CB, Weimer BC, Mills DA, German JB, Sonnenburg JL. Bacteroides in the infant gut consume milk oligosaccharides via mucus-utilization pathways. Cell Host Microbe. 2011 Nov 17;10(5):507-14. doi: 10.1016/j.chom.2011.10.007. Epub 2011 Oct 27.
PubMed 22036470Froehlich JW, Barboza M, Chu C, Lerno LA Jr, Clowers BH, Zivkovic AM, German JB, Lebrilla CB. Nano-LC-MS/MS of glycopeptides produced by nonspecific proteolysis enables rapid and extensive site-specific glycosylation determination. Anal Chem. 2011 Jul 15;83(14):5541-7. doi: 10.1021/ac2003888. Epub 2011 Jun 28.
PubMed 21661761Sela DA, Li Y, Lerno L, Wu S, Marcobal AM, German JB, Chen X, Lebrilla CB, Mills DA. An infant-associated bacterial commensal utilizes breast milk sialyloligosaccharides. J Biol Chem. 2011 Apr 8;286(14):11909-18. doi: 10.1074/jbc.M110.193359. Epub 2011 Feb 2.
PubMed 21288901Nwosu CC, Strum JS, An HJ, Lebrilla CB. Enhanced detection and identification of glycopeptides in negative ion mode mass spectrometry. Anal Chem. 2010 Dec 1;82(23):9654-62. doi: 10.1021/ac101856r. Epub 2010 Nov 4.
PubMed 21049935Zivkovic AM, German JB, Lebrilla CB, Mills DA. Human milk glycobiome and its impact on the infant gastrointestinal microbiota. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4653-8. doi: 10.1073/pnas.1000083107. Epub 2010 Aug 2.
PubMed 20679197Froehlich JW, Dodds ED, Barboza M, McJimpsey EL, Seipert RR, Francis J, An HJ, Freeman S, German JB, Lebrilla CB. Glycoprotein expression in human milk during lactation. J Agric Food Chem. 2010 May 26;58(10):6440-8. doi: 10.1021/jf100112x.
PubMed 20415418Marcobal A, Barboza M, Froehlich JW, Block DE, German JB, Lebrilla CB, Mills DA. Consumption of human milk oligosaccharides by gut-related microbes. J Agric Food Chem. 2010 May 12;58(9):5334-40. doi: 10.1021/jf9044205.
PubMed 20394371Ninonuevo MR, Ward RE, LoCascio RG, German JB, Freeman SL, Barboza M, Mills DA, Lebrilla CB. Methods for the quantitation of human milk oligosaccharides in bacterial fermentation by mass spectrometry. Anal Biochem. 2007 Feb 1;361(1):15-23. doi: 10.1016/j.ab.2006.11.010. Epub 2006 Nov 27.
PubMed 17181994Locascio RG, Ninonuevo MR, Kronewitter SR, Freeman SL, German JB, Lebrilla CB, Mills DA. A versatile and scalable strategy for glycoprofiling bifidobacterial consumption of human milk oligosaccharides. Microb Biotechnol. 2009 May;2(3):333-42. doi: 10.1111/j.1751-7915.2008.00072.x. Epub 2008 Dec 5.
PubMed 21261928Ninonuevo MR, Perkins PD, Francis J, Lamotte LM, LoCascio RG, Freeman SL, Mills DA, German JB, Grimm R, Lebrilla CB. Daily variations in oligosaccharides of human milk determined by microfluidic chips and mass spectrometry. J Agric Food Chem. 2008 Jan 23;56(2):618-26. doi: 10.1021/jf071972u. Epub 2007 Dec 19.
PubMed 18088092
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Deconstruction of Human Milk Oligosaccharides and Lipids
- ClinicalTrials.gov ID
- NCT01817127
- Acronym / sponsor ID
- 216198
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Dairy Research Foundation
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 4 Sep 2028 (estimated)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women and women diagnosed with gestational diabetes mellitus or type 2 diabetes mellitus.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Microbiota
Time frame: 3rd trimester pregnancy and Day 2-Day 366 postpartum
Proteome
Time frame: Day 2-Day 366 postpartum
Lipidome
Time frame: Day 2-Day 366 postpartum
Maternal plasma lipids
Time frame: 3rd trimester pregnancy and 2 months postpartum
Peptidome
Time frame: 3rd trimester pregnancy and Day 2-Day 366
Metabolome by Nuclear Magnetic Spectroscopy (NMR)
Time frame: 3rd trimester of pregnancy and D2-Day 366
Metabolome by MS
Time frame: Day 2-Day 366 postpartum
Secretor status genotyping
Time frame: 3rd trimester pregnancy and Day 60 postpartum
Maternal fasting and postprandial blood sugar
Time frame: 3rd trimester of pregnancy and Day 3-7
Maternal plasma lipoprotein size distribution
Time frame: 3rd trimester of pregnancy and Day 60 postpartum
Human Milk Transcriptomics
Time frame: 3 and 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 23140396Totten SM, Zivkovic AM, Wu S, Ngyuen U, Freeman SL, Ruhaak LR, Darboe MK, German JB, Prentice AM, Lebrilla CB. Comprehensive profiles of human milk oligosaccharides yield highly sensitive and specific markers for determining secretor status in lactating mothers. J Proteome Res. 2012 Dec 7;11(12):6124-33. doi: 10.1021/pr300769g. Epub 2012 Nov 19.
- Background: PubMed 22900748De Leoz ML, Gaerlan SC, Strum JS, Dimapasoc LM, Mirmiran M, Tancredi DJ, Smilowitz JT, Kalanetra KM, Mills DA, German JB, Lebrilla CB, Underwood MA. Lacto-N-tetraose, fucosylation, and secretor status are highly variable in human milk oligosaccharides from women delivering preterm. J Proteome Res. 2012 Sep 7;11(9):4662-72. doi: 10.1021/pr3004979. Epub 2012 Aug 28.
- Background: PubMed 22752723Neville MC, Anderson SM, McManaman JL, Badger TM, Bunik M, Contractor N, Crume T, Dabelea D, Donovan SM, Forman N, Frank DN, Friedman JE, German JB, Goldman A, Hadsell D, Hambidge M, Hinde K, Horseman ND, Hovey RC, Janoff E, Krebs NF, Lebrilla CB, Lemay DG, MacLean PS, Meier P, Morrow AL, Neu J, Nommsen-Rivers LA, Raiten DJ, Rijnkels M, Seewaldt V, Shur BD, VanHouten J, Williamson P. Lactation and neonatal nutrition: defining and refining the critical questions. J Mammary Gland Biol Neoplasia. 2012 Jun;17(2):167-88. doi: 10.1007/s10911-012-9261-5. Epub 2012 Jul 1.
- Background: PubMed 22745059Garrido D, Nwosu C, Ruiz-Moyano S, Aldredge D, German JB, Lebrilla CB, Mills DA. Endo-beta-N-acetylglucosaminidases from infant gut-associated bifidobacteria release complex N-glycans from human milk glycoproteins. Mol Cell Proteomics. 2012 Sep;11(9):775-85. doi: 10.1074/mcp.M112.018119. Epub 2012 Jun 27.
- Background: PubMed 22138995Sela DA, Garrido D, Lerno L, Wu S, Tan K, Eom HJ, Joachimiak A, Lebrilla CB, Mills DA. Bifidobacterium longum subsp. infantis ATCC 15697 alpha-fucosidases are active on fucosylated human milk oligosaccharides. Appl Environ Microbiol. 2012 Feb;78(3):795-803. doi: 10.1128/AEM.06762-11. Epub 2011 Dec 2.
- Background: PubMed 22036470Marcobal A, Barboza M, Sonnenburg ED, Pudlo N, Martens EC, Desai P, Lebrilla CB, Weimer BC, Mills DA, German JB, Sonnenburg JL. Bacteroides in the infant gut consume milk oligosaccharides via mucus-utilization pathways. Cell Host Microbe. 2011 Nov 17;10(5):507-14. doi: 10.1016/j.chom.2011.10.007. Epub 2011 Oct 27.
- Background: PubMed 21661761Froehlich JW, Barboza M, Chu C, Lerno LA Jr, Clowers BH, Zivkovic AM, German JB, Lebrilla CB. Nano-LC-MS/MS of glycopeptides produced by nonspecific proteolysis enables rapid and extensive site-specific glycosylation determination. Anal Chem. 2011 Jul 15;83(14):5541-7. doi: 10.1021/ac2003888. Epub 2011 Jun 28.
- Background: PubMed 21288901Sela DA, Li Y, Lerno L, Wu S, Marcobal AM, German JB, Chen X, Lebrilla CB, Mills DA. An infant-associated bacterial commensal utilizes breast milk sialyloligosaccharides. J Biol Chem. 2011 Apr 8;286(14):11909-18. doi: 10.1074/jbc.M110.193359. Epub 2011 Feb 2.
- Background: PubMed 21049935Nwosu CC, Strum JS, An HJ, Lebrilla CB. Enhanced detection and identification of glycopeptides in negative ion mode mass spectrometry. Anal Chem. 2010 Dec 1;82(23):9654-62. doi: 10.1021/ac101856r. Epub 2010 Nov 4.
- Background: PubMed 20679197Zivkovic AM, German JB, Lebrilla CB, Mills DA. Human milk glycobiome and its impact on the infant gastrointestinal microbiota. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4653-8. doi: 10.1073/pnas.1000083107. Epub 2010 Aug 2.
- Background: PubMed 20415418Froehlich JW, Dodds ED, Barboza M, McJimpsey EL, Seipert RR, Francis J, An HJ, Freeman S, German JB, Lebrilla CB. Glycoprotein expression in human milk during lactation. J Agric Food Chem. 2010 May 26;58(10):6440-8. doi: 10.1021/jf100112x.
- Background: PubMed 20394371Marcobal A, Barboza M, Froehlich JW, Block DE, German JB, Lebrilla CB, Mills DA. Consumption of human milk oligosaccharides by gut-related microbes. J Agric Food Chem. 2010 May 12;58(9):5334-40. doi: 10.1021/jf9044205.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce German, PhD principal investigator
University of California, Davis
Carlito Lebrilla, PhD principal investigator
University of California, Davis
David Mills, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Gestational Diabetes Mellitus, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human milk glycans (time frame: Change from day 2 to day 366). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817127, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.