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Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Study Formula | Active Comparator | protein hydrolysate formula |
|
| Experimental Study Formula | Experimental | free-amino acid-based medical food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Study Formula | Other | feed as lib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | weight gain during the study period | 14 days of age to 112 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric Measurements | length, head circumference, and length gain | 14 days of age to 112 days of age |
| GI Tolerance | daily stool number, stool consistency, formula intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene W Borschel, PhD, RD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| T&W Research | Little Rock | Arkansas | 72211 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006765 | Derived | Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. |
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| ID | Term |
|---|---|
| C097269 | pregestimil |
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| Experimental Study Formula | Other | feed as lib |
|
|
| At visits 14 and 28 |
| Lab Measurement | serum albumin | At 112 day visit |
| Iowa City |
| Iowa |
| 52242-1083 |
| United States |