Effects of Complementary Feeding on Infant Growth and Gut Health (MINT)

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.

Study Overview

• Status: Recruiting
• Conditions: Gut Microbiome; Linear Growth
• Intervention / Treatment: Other: Baby Foods - Meat; Other: Baby Foods - Dairy; Other: Baby Foods - Plant; Other: Foods from the home

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-2232; 1R01DK126710-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No