Clinical trial NCT02142647: Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health
Official title: Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Growth
Infant Body Fat
Infant Gut Microbiome
Keywords: infant growth
dietary protein
body composition
gut microbiome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
name: National Cattlemen's Beef Association
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-05-20
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of linear growth
timeFrame: 6 months
Secondary outcomes:
measure: Change in Body composition
timeFrame: 5 and 12 months of age
Other outcomes:
measure: Change in gut microbiome
timeFrame: 5, 9.5 and 12 months of age
Locations:
city: Aurora
country: United States
facility: UC Denver
state: Colorado
Study officials:
affiliation: UC Denver
name: Nancy Krebs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang M, Andersen V, Hendricks AE, Krebs NF. Different Growth Patterns Persist at 24 Months of Age in Formula-Fed Infants Randomized to Consume a Meat- or Dairy-Based Complementary Diet from 5 to 12 Months of Age. J Pediatr. 2019 Mar;206:78-82. doi: 10.1016/j.jpeds.2018.10.020. Epub 2018 Nov 6.
citation: Tang M, Hendricks AE, Krebs NF. A meat- or dairy-based complementary diet leads to distinct growth patterns in formula-fed infants: a randomized controlled trial. Am J Clin Nutr. 2018 May 1;107(5):734-742. doi: 10.1093/ajcn/nqy038.