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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

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Linear Growth Neurodevelopment Gut Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Study Provided Diet

A group of complementary foods provided to participants by researchers.

Group Type EXPERIMENTAL

Baby Foods

Intervention Type OTHER

Commercially available baby foods

Traditional Diet

No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.

Group Type PLACEBO_COMPARATOR

Foods from the home

Intervention Type OTHER

Caregiver will provide participant with usual foods from the home

Interventions

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Baby Foods

Commercially available baby foods

Intervention Type OTHER

Foods from the home

Caregiver will provide participant with usual foods from the home

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes