The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health

Gut Microbiome Clinical Trial

Official title:

The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137445
• Other study ID #: 19-0546
• Secondary ID: R01DK126710
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: June 2023

Study information

• Verified date: February 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

The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants.

The three primary aims include:

Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants.

Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota.

Aim 3: Characterize infant neurodevelopment and sleep patterns.

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: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 6 Months

Eligibility

Inclusion Criteria:

• Full term: gestational age > 37 weeks

• Exclusively breastfed (< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.

• Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.

Exclusion Criteria:

• Large for gestational age or small for gestational age

• Antibiotic use from birth to the time of enrollment

• Documented food allergies

• Previous complementary food exposure

• Conditions that would affect protein metabolism or growth

Related Conditions & MeSH terms

• Gut Microbiome
• Linear Growth
• Neurodevelopment

Intervention

Other:
• Baby Foods
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	Gut Microbiome	Gut microbiota structure by 16S sequencing	Over 6 months
Secondary	Neurodevelopment	Fine motor skills and cognition measured by the Bayley - III	At 12 months of age
Secondary	Duration of sleep	Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph	Over 6 months
Secondary	Body composition	Body fat mass, fat-free mass measured by stable isotopes	Over 6 months
Secondary	Serum c-reactive protein (CRP-hs)	Measured in mg/L	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	Dietary intake	3 day dietary recall with results generated by NDSR software	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