Effects of Complementary Feeding on Infant Growth and Gut Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gut Microbiome
- Sponsor
- University of Colorado, Denver
- Enrollment
- 267
- Locations
- 1
- Primary Endpoint
- Weight
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This study plans to learn more about how consuming different foods during the time of early complementary feeding (~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices.
The three primary aims include:
Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth.
Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development.
Aim 3. Identify gut microbial taxa and genes that affect infant growth.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Full term;
- •Generally healthy without conditions that would affect protein metabolism or growth
- •No previous complementary food exposure
- •Vaginal delivery
- •No prior exposure of antibiotics during delivery or after birth
- •Able to consume study foods
- •Single birth.
Exclusion Criteria
- •Pre-term infants.
- •Having conditions that would affect normal growth
- •Had complementary foods prior to the start of the study
- •Not willing to consume the complementary foods provided
- •Antibiotics exposure during delivery or from birth to 5 months of life
- •Multiple births
Outcomes
Primary Outcomes
Weight
Time Frame: Over 6 months
Measured in kg
Length
Time Frame: Over 6 months
Measured in cm
Body composition
Time Frame: Over 6 months
Body fat mass, fat-free mass measured by stable isotopes
Gut Microbiome
Time Frame: Over 6 months
Gut microbiota structure by 16S sequencing
Secondary Outcomes
- Total calories in breast milk(Over 6 months)
- Total carbohydrates in breast milk(Over 6 months)
- Total protein in breast milk(Over 6 months)
- Total fat in breast milk(Over 6 months)
- Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)(Over 6 months)
- Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)(Over 6 months)
- Serum c-reactive protein (CRP-hs)(Over 6 months)
- Plasma alpha 1-acid glycoprotein (AGP)(Over 6 months)
- Dietary intake(Over 6 months)
- Food acceptance(Over 6 months)