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

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.

Study Overview

• Status: Recruiting
• Conditions: Gut Microbiome; Neurodevelopment; Linear Growth
• Intervention / Treatment: Other: Foods from the home; Other: Baby Foods

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Provided Diet; A group of complementary foods provided to participants by researchers.	Other: Baby Foods; Commercially available baby foods
PLACEBO_COMPARATOR: Traditional Diet; No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.	Other: Foods from the home; Caregiver will provide participant with usual foods from the home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Measured in kg	Over 6 months
Length	Measured in cm	Over 6 months
Gut Microbiome	Gut microbiota structure by 16S sequencing	Over 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body fat mass, fat-free mass measured by stable isotopes	Over 6 months
Total calories in breast milk	Measured in kcal/100 mL	Over 6 months
Total carbohydrates in breast milk	Measured in g/100 mL	Over 6 months
Total protein in breast milk	Measured in g/100 mL	Over 6 months
Total fat in breast milk	Measured in g/100 mL	Over 6 months
Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)	Measured in ng/mL	Over 6 months
Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)	Measured in ng/mL	Over 6 months
Serum c-reactive protein (CRP-hs)	Measured in mg/L	Over 6 months
Dietary intake	3 day dietary recall with results generated by NDSR software	Over 6 months
Neurodevelopment	Fine motor skills and cognition measured by the Bayley - III	At 12 months of age
Duration of sleep	Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph	Over 6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (ACTUAL): October 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Complementary Feeding
• Other Study ID Numbers: 19-0546; R01DK126710 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No