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

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Linear Growth; Gut Microbiome

Treatments: Other: Baby Foods - Meat; Other: Foods from the home; Other: Baby Foods - Plant; Other: Baby Foods - Dairy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05012930

20-2232

1R01DK126710-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 4 to 60 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 4 patient groups, including a placebo group

Study Provided Diet - Meat

Experimental group

Description:

A group of complementary foods provided to participants by researchers.

Treatment:

Other: Baby Foods - Meat

Study Provided Diet - Plant

Experimental group

Description:

A group of complementary foods provided to participants by researchers.

Treatment:

Other: Baby Foods - Dairy

Study Provided Diet - Dairy

Experimental group

Description:

A group of complementary foods provided to participants by researchers.

Treatment:

Other: Baby Foods - Plant

Traditional Diet

Placebo Comparator group

Description:

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

Treatment:

Other: Foods from the home