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

Not Applicable

Completed

• Conditions: Infant Gut Microbiome; Infant Body Fat; Infant Growth
• Interventions: Behavioral: a high-protein complementary diet with dairy; Behavioral: a high-protein complementary diet with meat

• Registration Number: NCT02142647
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-20
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dairy group	a high-protein complementary diet with dairy	infants in this group will receive complementary foods mainly from dairy
meat group	a high-protein complementary diet with meat	Infants in this group will receive complementary foods with high protein content mainly from meat

Primary Outcome Measures

Name	Time	Method
Change of linear growth	6 months	growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study.

Secondary Outcome Measures

Name	Time	Method
Change in Body composition	5 and 12 months of age	body composition: fat mass, fat-free mass will be assessed at the beginning and end of the study

Trial Locations

Locations (1)

UC Denver; 🇺🇸 Aurora, Colorado, United States