Infant Body Fat, Infant Growth, Infant Gut Microbiome
Conditions
Keywords
infant growth, dietary protein, body composition, gut microbiome
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.
Interventions
BEHAVIORALa high-protein complementary diet with meat
infants will consume a high-protein complementary diet with protein mainly from meat
BEHAVIORALa high-protein complementary diet with dairy
infants will consume a high-protein complementary diet with protein mainly from dairy
Sponsors
Colorado Clinical & Translational Sciences Institute
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in gut microbiome | 5, 9.5 and 12 months of age | Gut microbiota profile will be measured at the beginning, mid point, and end of the intervention by collecting stool samples |
Countries
United States
Outcome results
None listed