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

Study Overview
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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.

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

Official Title
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Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health

Conditions
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Infant Growth, Infant Body Fat, Infant Gut Microbiome

Intervention / Treatment
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* Behavioral: a high-protein complementary diet with meat
* Behavioral: a high-protein complementary diet with dairy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: meat group<br>Infants in this group will receive complementary foods with high protein content mainly from meat | Behavioral: a high-protein complementary diet with meat<br>* infants will consume a high-protein complementary diet with protein mainly from meat<br>|
| Active Comparator: dairy group<br>infants in this group will receive complementary foods mainly from dairy | Behavioral: a high-protein complementary diet with dairy<br>* infants will consume a high-protein complementary diet with protein mainly from dairy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of linear growth | growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body composition | body composition: fat mass, fat-free mass will be assessed at the beginning and end of the study | 5 and 12 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant growth, dietary protein, body composition, gut microbiome