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| Name | Class |
|---|---|
| BioFortis | OTHER |
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The aim of this clinical trial is to assess the effects of daily consumption of soy protein foods on body composition, general health status and dietary intake outcomes in generally healthy children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Protein Group | Active Comparator | Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the United States Department of Agricultural (USDA) MyPlate program (www.choosemyplate.gov). Subjects in this intervention group will not receive study provided foods. |
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| Soy Protein Group | Experimental | Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the USDA MyPlate program (www.choosemyplate.gov) with the incorporation of two servings of study food providing soy protein per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy protein containing foods | Other | Daily consumption of 2 food products, each providing 15g of soy protein per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| change in body composition | DXA | week 0, week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research | Addison | Illinois | 60101 | United States |
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| Dietary Guidance | Behavioral | Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the United States Department of Agricultural (USDA) MyPlate program (www.choosemyplate.gov). Subjects in this intervention group will not receive study provided foods. |
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