Effect of Protein From Complementary Foods on Infant Growth, Body Composition 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

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-08-31

Brief Summary

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Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet. This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.

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Detailed Description

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Two observational follow-up visits will be conducted at 18 and 24 months of age.

Conditions

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Infant Growth Infant Body Fat Infant Gut Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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meat group

Infants in this group will receive complementary foods with high protein content mainly from meat

Group Type ACTIVE_COMPARATOR

a high-protein complementary diet with meat

Intervention Type BEHAVIORAL

infants will consume a high-protein complementary diet with protein mainly from meat

dairy group

infants in this group will receive complementary foods mainly from dairy

Group Type ACTIVE_COMPARATOR

a high-protein complementary diet with dairy

Intervention Type BEHAVIORAL

infants will consume a high-protein complementary diet with protein mainly from dairy

Interventions

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a high-protein complementary diet with meat

infants will consume a high-protein complementary diet with protein mainly from meat

Intervention Type BEHAVIORAL

a high-protein complementary diet with dairy

infants will consume a high-protein complementary diet with protein mainly from dairy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 1-5 months of age
* Formula fed
* On breast milk less than 1 month
* Healthy
* Term Birth (36-42 weeks)
* Appropriate for gestational age

Exclusion Criteria

* Congenital anomalies that impact feeding, growth, or development
* Low birth weight
* Not able to consume milk-based formula
* Known chronic diseases or allergies affecting protein consumption/digestion

Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes