The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
- Conditions
- Linear GrowthNeurodevelopmentGut Microbiome
- Interventions
- Other: Baby FoodsOther: Foods from the home
- Registration Number
- NCT04137445
- Lead Sponsor
- University of Colorado, Denver
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Provided Diet Baby Foods A group of complementary foods provided to participants by researchers. Traditional Diet Foods from the home No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.
- Primary Outcome Measures
Name Time Method Weight Over 6 months Measured in kg
Length Over 6 months Measured in cm
Gut Microbiome Over 6 months Gut microbiota structure by 16S sequencing
- Secondary Outcome Measures
Name Time Method Neurodevelopment At 12 months of age Fine motor skills and cognition measured by the Bayley - III
Serum IGFBP-3 (Insulin-like growth factor-binding protein 3) Over 6 months Measured in ng/mL
Total protein in breast milk Over 6 months Measured in g/100 mL
Body composition Over 6 months Body fat mass, fat-free mass measured by stable isotopes
Duration of sleep Over 6 months Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C) Over 6 months Measured in ng/mL
Dietary intake Over 6 months 3 day dietary recall with results generated by NDSR software
Serum c-reactive protein (CRP-hs) Over 6 months Measured in mg/L
Total calories in breast milk Over 6 months Measured in kcal/100 mL
Total carbohydrates in breast milk Over 6 months Measured in g/100 mL
Total fat in breast milk Over 6 months Measured in g/100 mL
Trial Locations
- Locations (1)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States