Effects of Complementary Feeding on Infant Growth 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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2027-07-31

Brief Summary

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This study plans to learn more about how consuming different foods during the time of early complementary feeding (\~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices.

The three primary aims include:

Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth.

Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development.

Aim 3. Identify gut microbial taxa and genes that affect infant growth.

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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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Gut Microbiome Linear Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

6 months intervention from \~5-12 months with follow-up assessments at 18 and 24 months.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Study Provided Diet - Meat

A group of complementary foods provided to participants by researchers.

Group Type EXPERIMENTAL

Baby Foods - Meat

Intervention Type OTHER

Commercially available baby foods

Study Provided Diet - Plant

A group of complementary foods provided to participants by researchers.

Group Type EXPERIMENTAL

Baby Foods - Dairy

Intervention Type OTHER

Commercially available baby foods

Study Provided Diet - Dairy

A group of complementary foods provided to participants by researchers.

Group Type EXPERIMENTAL

Baby Foods - Plant

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 - Meat

Commercially available baby foods

Intervention Type OTHER

Baby Foods - Dairy

Commercially available baby foods

Intervention Type OTHER

Baby Foods - Plant

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;
* Generally healthy without conditions that would affect protein metabolism or growth
* No previous complementary food exposure
* Vaginal delivery
* No prior exposure of antibiotics during delivery or after birth
* Able to consume study foods
* Single birth.

Exclusion Criteria

* Pre-term infants.
* Having conditions that would affect normal growth
* Had complementary foods prior to the start of the study
* Not willing to consume the complementary foods provided
* Antibiotics exposure during delivery or from birth to 5 months of life
* Multiple births

Minimum Eligible Age

4 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes