This trial is active, not recruiting.

Conditions infant growth, infant body fat, infant gut microbiome
Treatments a high-protein complementary diet with meat, a high-protein complementary diet with dairy
Sponsor University of Colorado, Denver
Collaborator National Pork Board
Start date March 2014
End date July 2018
Trial size 40 participants
Trial identifier NCT02142647, 14-0139


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
(Active Comparator)
Infants in this group will receive complementary foods with high protein content mainly from meat
a high-protein complementary diet with meat
infants will consume a high-protein complementary diet with protein mainly from meat
(Active Comparator)
infants in this group will receive complementary foods mainly from dairy
a high-protein complementary diet with dairy
infants will consume a high-protein complementary diet with protein mainly from dairy

Primary Outcomes

Change of linear growth
time frame: 6 months

Secondary Outcomes

Change in Body composition
time frame: 5 and 12 months of age

Eligibility Criteria

Male or female participants from 1 month up to 5 months old.

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

Additional Information

Official title Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
Principal investigator Nancy Krebs, MD
Description Two observational follow-up visits will be conducted at 18 and 24 months of age.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.