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 complementary feeding (\~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants. The three primary aims include: Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants. Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota. Aim 3: Characterize infant neurodevelopment and sleep patterns.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
100
Commercially available baby foods
Caregiver will provide participant with usual foods from the home
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGWeight
Measured in kg
Time frame: Over 6 months
Length
Measured in cm
Time frame: Over 6 months
Gut Microbiome
Gut microbiota structure by 16S sequencing
Time frame: Over 6 months
Neurodevelopment
Fine motor skills and cognition measured by the Bayley - III
Time frame: At 12 months of age
Duration of sleep
Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph
Time frame: Over 6 months
Body composition
Body fat mass, fat-free mass measured by stable isotopes
Time frame: Over 6 months
Serum c-reactive protein (CRP-hs)
Measured in mg/L
Time frame: Over 6 months
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
Measured in ng/mL
Time frame: Over 6 months
Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)
Measured in ng/mL
Time frame: Over 6 months
Dietary intake
3 day dietary recall with results generated by NDSR software
Time frame: Over 6 months
Total calories in breast milk
Measured in kcal/100 mL
Time frame: Over 6 months
Total carbohydrates in breast milk
Measured in g/100 mL
Time frame: Over 6 months
Total protein in breast milk
Measured in g/100 mL
Time frame: Over 6 months
Total fat in breast milk
Measured in g/100 mL
Time frame: Over 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.