Trials / Completed
CompletedNCT02142647
Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health
Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 1 Month – 5 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | a high-protein complementary diet with meat | infants will consume a high-protein complementary diet with protein mainly from meat |
| BEHAVIORAL | a high-protein complementary diet with dairy | infants will consume a high-protein complementary diet with protein mainly from dairy |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2014-05-20
- Last updated
- 2019-07-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02142647. Inclusion in this directory is not an endorsement.