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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Infant Growth; Infant Body Fat; Infant Gut Microbiome

Treatments: Behavioral: a high-protein complementary diet with dairy; Behavioral: a high-protein complementary diet with meat

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02142647

14-0139

Details and patient eligibility

About

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.

Full description

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

Enrollment: 75 patients

Sex: All

Ages: 1 to 5 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

meat group

Active Comparator group

Description:

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

Treatment:

Behavioral: a high-protein complementary diet with meat

dairy group

Active Comparator group

Description:

infants in this group will receive complementary foods mainly from dairy

Treatment:

Behavioral: a high-protein complementary diet with dairy