Status:
UNKNOWN
The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Linear Growth
Neurodevelopment
Eligibility:
All Genders
5-6 years
Phase:
NA
Brief Summary
The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early c...
Detailed Description
Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.
Eligibility Criteria
Inclusion
- Full term: gestational age \> 37 weeks
- Exclusively breastfed (\< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.
- Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.
Exclusion
- Large for gestational age or small for gestational age
- Antibiotic use from birth to the time of enrollment
- Documented food allergies
- Previous complementary food exposure
- Conditions that would affect protein metabolism or growth
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04137445
Start Date
March 15 2020
End Date
June 1 2023
Last Update
February 2 2023
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045