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

Completed · Not applicable

Conditions studied: Infant Growth, Infant Body Fat, Infant Gut Microbiome

In brief

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.

Key facts

Study ID

NCT02142647

Run by

University of Colorado, Denver

People needed

75

Starts

2014-03-01

Expected to finish

2018-08-01

Last updated by the study team

2019-07-10

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• UC Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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