Gut Microbiome, Linear Growth
Conditions
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.
Interventions
OTHERBaby Foods - Meat
Commercially available baby foods
OTHERBaby Foods - Dairy
Commercially available baby foods
OTHERBaby Foods - Plant
Commercially available baby foods
OTHERFoods from the home
Caregiver will provide participant with usual foods from the home
Sponsors
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
6 months intervention from \ 5-12 months with follow-up assessments at 18 and 24 months.
Eligibility
Sex/Gender
ALL
Age
4 Months to 60 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Over 6 months | Measured in kg |
| Length | Over 6 months | Measured in cm |
| Body composition | Over 6 months | Body fat mass, fat-free mass measured by stable isotopes |
| Gut Microbiome | Over 6 months | Gut microbiota structure by 16S sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Serum c-reactive protein (CRP-hs) | Over 6 months | Measured in mg/L |
| Plasma alpha 1-acid glycoprotein (AGP) | Over 6 months | Measured in mg/L |
| Dietary intake | Over 6 months | 3 day dietary recall with results generated by NDSR software |
| Food acceptance | Over 6 months | Coded from behavioral observations and consumption measured in g |
Countries
United States
Outcome results
None listed