The UC Davis Lactation Study (http://ucdavis-lactation-study.org) is an ongoing clinical trial and is part of the Milk Bioactives Program and the Functional Glycobiology Program. We are currently recruiting women in their third trimester who live in Davis or Woodland, CA. We are investigating how certain components in breast milk affect the development of infant microflora.
The purpose of the UC Davis Lactation Study is to learn how oligosaccharide composition in human milk:
1) Changes over the course of lactation
2) Varies between mothers
3) Is affected by mother’s diet
4) Affects the development of the infant’s intestinal microflora
Volunteers will receive complimentary in-home lactation consultation & financial compensation!
Mother’s milk has evolved over time to nourish infants
Human milk contains 7% lactose, 4% fat, 1% proteins, 1% oligosaccharides, as well as minerals & other micronutrients.
Oligosaccharides are just sugar molecules linked together, but humans do not have the enzymes to digest them.
Q: So why does human milk contain these indigestible molecules ??
A: Oligosaccharides promote the growth of specific microflora in the infant’s gut.
These friendly bacteria:
1) Protect the infant from pathogens
2) Help the infant develop a healthy immune system
A detailed description of the study:
Who is conducting this Study?
This study is led by J. Bruce German, PhD, and colleagues at the UC Davis Food Science and Technology, Viticulture and Enology and Chemistry departments. This study has been reviewed and approved by the UC Davis Committee for the Protection of Human Subjects.
What is the purpose of the study?
This is a clinical trial aimed to measure the changes of different complex sugars and fats in breast milk over the first 6 months of lactation and to measure the effects of breastfeeding on the development of infants’ beneficial gut bacteria. The changes in breast milk composition will be tracked in milk pumped and collected by mothers on 28 separate days over the course of 6 months. We will also track changes in infants’ saliva and stool composition which mothers will collect on 21 separate days over the course of 1 year.
Who can participate?
We seek 100 healthy women in their third trimester of pregnancy who live in the Davis and Woodland area.
Who is NOT eligible to participate?
- Individuals who use tobacco products
- Individuals with a known metabolic illness except for gestational diabetes
- Individuals taking prescription or over-the-counter medications that include corticosteroids, medications for weight loss, medications for high blood pressure and high cholesterol and triglycerides, immunesuppressants
What is expected of me during the study?
This study requires a minimum 6 month commitment. The frequency of milk, saliva and stool collections will be higher at the beginning of the study and will taper off toward the end of the 6 month period. Mothers will collect 4 additional saliva and stool samples, during the last 6 months of the study. A Lactation Consultant will instruct mothers on how to pump their breast milk and transfer a portion of their milk into collection tubes; as well as how to swab their infant’s mouth to collect saliva and their infant’s stool into collection tubes. Mothers will store samples in their freezer until a scheduled pick up.
They will receive a phone call from the study’s Subject Coordinator about every two weeks for updates regarding their and their infant’s health. Participants will receive at least 4 house calls from one of the study’s Lactation Consultants throughout the study:
- Once, when mothers are pregnant, to discuss the basics of the study, to instruct on sample collection, and to answer questions about breastfeeding.
- A second time, close to the baby’s 3rd day of birth, to offer lactation support and administer a questionnaire about labor.
- The third and fourth visits will be scheduled when the baby is about 1 week old and 3 weeks old.
During these visits, the Lactation Consultant will pick up the participant’s first week’s worth of collected samples; provide lactation support and answer any questions regarding lactation and breastfeeding.
How will I be compensated?
Throughout the study, mothers will be provided with free lactation consultation from one of the study’s board certified Lactation Consultants in the comfort of their own homes. Participants will also receive $100 worth of compensation in the form of Target Gift Cards provided in three installments over the first 6 months of the study.
If you have any questions or are interested in being screened for the study, please call the Project Coordinator, Jennifer Smilowitz (888) 217-5355 or email at: [email protected]