Status:
COMPLETED
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Children's Hospital Los Angeles
University of California, San Diego
Conditions:
Obesity
Eligibility:
FEMALE
18-59 years
Brief Summary
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains certain natural...
Detailed Description
This project will examine specific factors in breast milk that may impact infant's gut microbiome development, and thereby impact their adiposity and weight gain in early life. An important early-life...
Eligibility Criteria
Inclusion
- Mothers who self-identify as Hispanic
- Mothers who have or have had singleton births
- Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
- Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
Exclusion
- Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
- Physical, mental, or cognitive issues that prevent participation
- Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
- Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
- Clinical diagnosis of gestational diabetes
- Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
- Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT04434027
Start Date
July 1 2016
End Date
August 1 2022
Last Update
March 28 2025
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027