NCT03522597Completed
Metabolism, Breastmilk, and Microbiome
Maternal Metabolism, Breast Milk Composition, and Infant Outcomes: The 4M Project
Source: ClinicalTrials.gov · Last updated 24 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2050 (actual)
- First submitted
- 22 Mar 2018
- Start date
- 1 Jun 2018
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity
- NCT number
- NCT03522597
What you commit to
- Study type: Observational
- Participants enrolled: 2050
- From 1 Jun 2018 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
- preexisting diabetes
Other
- alcohol consumption \>1 drink per week during pregnancy/lactation
- tobacco consumption during pregnancy/lactation,
- inability to speak/understand English
- planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.
Who the study is looking for
- (For new enrollment of 50 pregnant women with gestational diabetes and their infants. Enrollment of normal weight and obese cohort comparators already accomplished under ClinicalTrial NCT03301753):
- 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.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.