Effects of Complementary Feeding on Infant Growth and Gut Health

Gut Microbiome Clinical Trial

— MINT  

Official title:

Effects of Complementary Feeding on Infant Growth and Gut Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05012930
• Other study ID #: 20-2232
• Secondary ID: 1R01DK126710-01
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: January 2023
• Source: University of Colorado, Denver
• Contact: Minghua Tang, PhD
• Phone: 303-724-3248
• Email: minghua.tang[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 50 Months

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiome
• Linear Growth

Intervention

Other:
• Baby Foods - Meat
Commercially available baby foods
• Baby Foods - Dairy
Commercially available baby foods
• Baby Foods - Plant
Commercially available baby foods
• Foods from the home
Caregiver will provide participant with usual foods from the home

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Measured in kg	Over 6 months
Primary	Length	Measured in cm	Over 6 months
Primary	Head Circumference	Measured in cm	Over 6 months
Primary	Body composition	Body fat mass, fat-free mass measured by stable isotopes	Over 6 months
Primary	Gut Microbiome	Gut microbiota structure by 16S sequencing	Over 6 months
Secondary	Total calories in breast milk	Measured in kcal/100 mL	Over 6 months
Secondary	Total carbohydrates in breast milk	Measured in g/100 mL	Over 6 months
Secondary	Total protein in breast milk	Measured in g/100 mL	Over 6 months
Secondary	Total fat in breast milk	Measured in g/100 mL	Over 6 months
Secondary	Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)	Measured in ng/mL	Over 6 months
Secondary	Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)	Measured in ng/mL	Over 6 months
Secondary	Serum c-reactive protein (CRP-hs)	Measured in mg/L	Over 6 months
Secondary	Plasma alpha 1-acid glycoprotein (AGP)	Measured in mg/L	Over 6 months
Secondary	Dietary intake	3 day dietary recall with results generated by NDSR software	Over 6 months