Metabolism, Breastmilk, and Microbiome (NCT03522597) | Clinical Trial Compass
CompletedNot Applicable
Metabolism, Breastmilk, and Microbiome
United States2,050 participantsStarted 2018-06-01
Plain-language summary
The objective of this pilot study is to compare breast milk composition in mothers of three different metabolic states (normal weight, obese, and gestational diabetic) and to determine the extent to which breastmilk components are transmitted to the infant gut and are associated with the anthropometric and body composition changes in their infants during the first 6 months of life. It is hypothesized that 1) different maternal metabolic states will be associated with differences in breastmilk microbial communities and breastmilk biochemical features, 2) differences in these breastmilk biomarkers will be transmitted to infants and 3) breastmilk microbial and metabolic features will be associated with infant growth outcomes.
Who can participate
SexALL
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Inclusion criteria
✓. Pregnant women
✓. age 21-45 at time of delivery
✓. report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity \>1, that they successfully breastfed after a previous pregnancy for at least 3 months
✓. singleton pregnancy
✓. known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test \>200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
Exclusion criteria
✕. alcohol consumption \>1 drink per week during pregnancy/lactation
✕. tobacco consumption during pregnancy/lactation,
✕. inability to speak/understand English
✕. known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
✕. planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.