Gut Microbiome, Linear Growth, Neurodevelopment
Conditions
Keywords
Complementary Feeding
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.
Interventions
OTHERBaby Foods
Commercially available baby foods
OTHERFoods from the home
Caregiver will provide participant with usual foods from the home
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopment | At 12 months of age | Fine motor skills and cognition measured by the Bayley - III |
| Duration of sleep | Over 6 months | Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph |
| Body composition | Over 6 months | Body fat mass, fat-free mass measured by stable isotopes |
| Serum c-reactive protein (CRP-hs) | Over 6 months | Measured in mg/L |
| Serum IGF-1 (Insulin-like growth factor1/ somatomedin C) | Over 6 months | Measured in ng/mL |
| Serum IGFBP-3 (Insulin-like growth factor-binding protein 3) | Over 6 months | Measured in ng/mL |
| Dietary intake | Over 6 months | 3 day dietary recall with results generated by NDSR software |
| 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 protein in breast milk | Over 6 months | Measured in g/100 mL |
| Total fat in breast milk | Over 6 months | Measured in g/100 mL |
Countries
United States
Contacts
Primary ContactMinghua Tang, PhD
Outcome results
None listed