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OpenTrials
Active, Not Recruiting

NCT Number: NCT05012930

Effects of Complementary Feeding on Infant Growth and Gut Health

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gut Microbiome Linear Growth

Age range

4 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby Foods - Meat

Other

Commercially available baby foods

Baby Foods - Dairy

Other

Commercially available baby foods

Baby Foods - Plant

Other

Commercially available baby foods

Foods from the home

Other

Caregiver will provide participant with usual foods from the home

Primary outcomes

  1. Weight

    Time frame: Over 6 months

    Measured in kg

  2. Length

    Time frame: Over 6 months

    Measured in cm

  3. Body composition

    Time frame: Over 6 months

    Body fat mass, fat-free mass measured by stable isotopes

  4. Gut Microbiome

    Time frame: Over 6 months

    Gut microbiota structure by 16S sequencing

Secondary outcomes

  1. Total calories in breast milk

    Time frame: Over 6 months

    Measured in kcal/100 mL

  2. Total carbohydrates in breast milk

    Time frame: Over 6 months

    Measured in g/100 mL

  3. Total protein in breast milk

    Time frame: Over 6 months

    Measured in g/100 mL

  4. Total fat in breast milk

    Time frame: Over 6 months

    Measured in g/100 mL

  5. Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)

    Time frame: Over 6 months

    Measured in ng/mL

  6. Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)

    Time frame: Over 6 months

    Measured in ng/mL

  7. Serum c-reactive protein (CRP-hs)

    Time frame: Over 6 months

    Measured in mg/L

  8. Plasma alpha 1-acid glycoprotein (AGP)

    Time frame: Over 6 months

    Measured in mg/L

  9. Dietary intake

    Time frame: Over 6 months

    3 day dietary recall with results generated by NDSR software

  10. Food acceptance

    Time frame: Over 6 months

    Coded from behavioral observations and consumption measured in g

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Acronym: MINT

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Aug 19, 2021
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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