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

Description

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.

Conditions

Linear Growth, Neurodevelopment, Gut Microbiome

Study Overview

Study Details

Study overview

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.

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

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

Condition
Linear Growth
Intervention / Treatment

-

Contacts and Locations

Aurora

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

5 Months to 6 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Colorado, Denver,

Minghua Tang, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2023-06