Effects of Complementary Feeding on Infant Growth and Gut Health

Study 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. 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.

Official Title
-----------------
Effects of Complementary Feeding on Infant Growth and Gut Health

Conditions
-----------------
Gut Microbiome, Linear Growth

Intervention / Treatment
-----------------
* Other: Baby Foods - Meat
* Other: Baby Foods - Dairy
* Other: Baby Foods - Plant
* Other: Foods from the home


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 50 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Provided Diet - Meat<br>A group of complementary foods provided to participants by researchers. | Other: Baby Foods - Meat<br>* Commercially available baby foods<br>|
| Experimental: Study Provided Diet - Plant<br>A group of complementary foods provided to participants by researchers. | Other: Baby Foods - Dairy<br>* Commercially available baby foods<br>|
| Experimental: Study Provided Diet - Dairy<br>A group of complementary foods provided to participants by researchers. | Other: Baby Foods - Plant<br>* Commercially available baby foods<br>|
| Placebo Comparator: Traditional Diet<br>No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers. | Other: Foods from the home<br>* Caregiver will provide participant with usual foods from the home<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Measured in kg | Over 6 months | 
| Length | Measured in cm | Over 6 months | 
| Head Circumference | Measured in cm | Over 6 months | 
| Body composition | Body fat mass, fat-free mass measured by stable isotopes | Over 6 months | 
| Gut Microbiome | Gut microbiota structure by 16S sequencing | Over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total calories in breast milk | Measured in kcal/100 mL | Over 6 months | 
| Total carbohydrates in breast milk | Measured in g/100 mL | Over 6 months | 
| Total protein in breast milk | Measured in g/100 mL | Over 6 months | 
| Total fat in breast milk | Measured in g/100 mL | Over 6 months | 
| Serum IGF-1 (Insulin-like growth factor1/ somatomedin C) | Measured in ng/mL | Over 6 months | 
| Serum IGFBP-3 (Insulin-like growth factor-binding protein 3) | Measured in ng/mL | Over 6 months | 
| Serum c-reactive protein (CRP-hs) | Measured in mg/L | Over 6 months | 
| Plasma alpha 1-acid glycoprotein (AGP) | Measured in mg/L | Over 6 months | 
| Dietary intake | 3 day dietary recall with results generated by NDSR software | Over 6 months |