NCT04137445

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 5 Months – 6 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• Linear Growth
• Neurodevelopment
• Gut Microbiome

Interventions

Type	Name	Description
OTHER	Baby Foods	Commercially available baby foods
OTHER	Foods from the home	Caregiver will provide participant with usual foods from the home

Timeline

• Start date: 2020-03-15
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2019-10-24
• Last updated: 2023-02-02

Locations

1 site across 1 country: United States