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| Name | Class |
|---|---|
| Colorado Clinical & Translational Sciences Institute | OTHER |
| National Cattlemen's Beef Association, a contractor to the Beef Checkoff | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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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.
Two observational follow-up visits will be conducted at 18 and 24 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meat group | Active Comparator | Infants in this group will receive complementary foods with high protein content mainly from meat |
|
| dairy group | Active Comparator | infants in this group will receive complementary foods mainly from dairy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a high-protein complementary diet with meat | Behavioral | infants will consume a high-protein complementary diet with protein mainly from meat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of linear growth | growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body composition | body composition: fat mass, fat-free mass will be assessed at the beginning and end of the study | 5 and 12 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiome | Gut microbiota profile will be measured at the beginning, mid point, and end of the intervention by collecting stool samples | 5, 9.5 and 12 months of age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Krebs, MD | UC Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37506974 | Derived | Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26. | |
| 30413312 | Derived |
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| a high-protein complementary diet with dairy | Behavioral | infants will consume a high-protein complementary diet with protein mainly from dairy |
|
| 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. |
| 29722841 | Derived | 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. |
| ID | Term |
|---|---|
| D008460 | Meat |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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