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The current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular function, and the relationship of these changes to the metabolome in school aged children (9 - 13 years of age).
Each participant will be asked to participate in a screening and 2 study intervention visits. Each intervention visit will include anthropometric measures, complete the education component, vascular function tests, and a blood draw and spot urine. The screening visit will confirm the child's eligibility for study enrollment and will serve to acclimate the child to the vascular function, and physical activity measurements. The remaining 2 visits will be scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical activity monitor, which in addition to tracking physical activity, will also be used to incorporate a nutrition education program. The parent/guardian will be asked to help with providing the child the daily food product and to help their child fill out the compliance log. Volunteers will also be sought for stool and saliva collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food Product 1 | Active Comparator | Macronutrient similar to experimental, micronutrient lower than experimental |
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| Food Product 2 | Active Comparator | Macronutrient lower than experimental, micronutrient similar to experimental |
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| Food Product 3 | Experimental | Experimental 1 |
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| Food Product 4 | Experimental | Experimental 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Product | Other | Each food product will provide similar calories, but a different micro- and macro-nutrient composition |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Microvascular Function | Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values | Compare change in baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Metabolome | Measured with Nuclear Magnetic Resonance (NMR) | Compare change in baseline and 4 weeks |
| Change in Lipidome | Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl L Keen, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition | Davis | California | 95616 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Double blind, controlled, 4 parallel arm design
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Products will look and taste similar, and will be provided in coded packaging
| Compare change in baseline and 4 weeks |
| Change in Inflammatory Markers | Measured by immunoassay | Compare change in baseline and 4 weeks |