Effects of Complementary Feeding on Infant Growth and Gut Health

NCT05012930 | Active Not Recruiting

• 2 other identifiers: 20-22321R01DK126710-01
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome; Linear Growth

Outcome Measures

Primary Outcomes (4)

• Weight

  Measured in kg

  Over 6 months

• Length

  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 Outcomes (10)

• 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

Study Arms (4)

Study Provided Diet - Meat

EXPERIMENTAL

A group of complementary foods provided to participants by researchers.

Other: Baby Foods - Meat

Study Provided Diet - Plant

EXPERIMENTAL

A group of complementary foods provided to participants by researchers.

Other: Baby Foods - Dairy

Study Provided Diet - Dairy

EXPERIMENTAL

A group of complementary foods provided to participants by researchers.

Other: Baby Foods - Plant

Traditional Diet

PLACEBO COMPARATOR

No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.

Other: Foods from the home

Interventions

Baby Foods - Meat OTHER

Commercially available baby foods

Study Provided Diet - Meat

Baby Foods - Dairy OTHER

Commercially available baby foods

Study Provided Diet - Plant

Baby Foods - Plant OTHER

Commercially available baby foods

Study Provided Diet - Dairy

Foods from the home OTHER

Caregiver will provide participant with usual foods from the home

Traditional Diet

Eligibility Criteria

• Age: 4 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Tang M, Matz KL, Berman LM, Davis KN, Melanson EL, Frank DN, Hendricks AE, Krebs NF. Effects of Complementary Feeding With Different Protein-Rich Foods on Infant Growth and Gut Health: Study Protocol. Front Pediatr. 2022 Jan 13;9:793215. doi: 10.3389/fped.2021.793215. eCollection 2021.

  PMID: 35096709 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6 months intervention from \~5-12 months with follow-up assessments at 18 and 24 months.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)