Effects of Complementary Feeding on Infant Growth and Gut Health

Not Applicable

Active, not recruiting

• Conditions: Gut Microbiome; Linear Growth
• Interventions: Other: Foods from the home; Other: Baby Foods - Plant; Other: Baby Foods - Meat; Other: Baby Foods - Dairy

• Registration Number: NCT05012930
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-07-14
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 267

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Diet	Foods from the home	No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.
Study Provided Diet - Dairy	Baby Foods - Plant	A group of complementary foods provided to participants by researchers.
Study Provided Diet - Meat	Baby Foods - Meat	A group of complementary foods provided to participants by researchers.
Study Provided Diet - Plant	Baby Foods - Dairy	A group of complementary foods provided to participants by researchers.

Primary Outcome Measures

Name	Time	Method
Weight	Over 6 months	Measured in kg
Length	Over 6 months	Measured in cm
Head Circumference	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States