Complementary Feeding for Infant Growth and Gut Health

(MINT Trial)

Overseen By Minghua Tang, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Antibiotics

Disqualifiers: Pre-term, Growth conditions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

267 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for full-term, healthy infants with no prior complementary food exposure or antibiotics use from birth to 5 months. Eligible babies must be able to eat the study foods and come from a single birth delivered vaginally.

Inclusion Criteria

No previous complementary food exposure

I am generally healthy with no conditions affecting my protein metabolism or growth.

No prior exposure of antibiotics during delivery or after birth

Exclusion Criteria

I am not willing to eat the study-provided food.

I was exposed to antibiotics from birth to 5 months old.

Had complementary foods prior to the start of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive complementary foods with different protein-rich foods to study their effects on growth and gut microbiota development

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Complementary Feeding

Trial Overview The study tests how different protein-rich baby foods (meat, plant, dairy) versus home-prepared foods affect an infant's growth and gut bacteria development during early feeding (~5-12 months).

Participant Groups

Group I: Study Provided Diet - Plant Experimental Treatment 1 Intervention

A group of complementary foods provided to participants by researchers.

Group II: Study Provided Diet - Meat Experimental Treatment 1 Intervention

A group of complementary foods provided to participants by researchers.

Group III: Study Provided Diet - Dairy Experimental Treatment 1 Intervention

A group of complementary foods provided to participants by researchers.

Group IV: Traditional Diet Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+