Clinical trial NCT04137445: The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
Official title: The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Linear Growth
Neurodevelopment
Gut Microbiome
Keywords: Complementary Feeding
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Over 6 months
measure: Length
timeFrame: Over 6 months
measure: Gut Microbiome
timeFrame: Over 6 months
Secondary outcomes:
measure: Neurodevelopment
timeFrame: At 12 months of age
measure: Duration of sleep
timeFrame: Over 6 months
measure: Body composition
timeFrame: Over 6 months
measure: Serum c-reactive protein (CRP-hs)
timeFrame: Over 6 months
measure: Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
timeFrame: Over 6 months
measure: Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)
timeFrame: Over 6 months
measure: Dietary intake
timeFrame: Over 6 months
measure: Total calories in breast milk
timeFrame: Over 6 months
measure: Total carbohydrates in breast milk
timeFrame: Over 6 months
measure: Total protein in breast milk
timeFrame: Over 6 months
measure: Total fat in breast milk
timeFrame: Over 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Minghua Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: