Assessment of a New Food Product in Metabolically at Risk Children

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children

Conditions
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Cardiovascular Risk Factor, Inflammation, Micronutrient Deficiency

Intervention / Treatment
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* Other: Food Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female 9-13 years old Subject is willing and able to comply with the study protocols Subject is willing to consume the test products Access to a smart phone or tablet at least 1x / week; and willing to download a free applications associated with the study Exclusion Criteria: Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten Under current medical supervision Tanner Score = 4 Non-English speaking Current participation in a daily exercise routine of moderate or high intensity Self-reported presence of disease, a history of serious illness, or who are currently under acute medical care. Currently taking prescription drugs or supplements Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements. Self-reported malabsorption or gastrointestinal issues Current enrollee in a clinical research study.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, controlled, 4 parallel arm design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Food Product 1<br>Macronutrient similar to experimental, micronutrient lower than experimental | Other: Food Product<br>* Each food product will provide similar calories, but a different micro- and macro-nutrient composition<br>|
| Active Comparator: Food Product 2<br>Macronutrient lower than experimental, micronutrient similar to experimental | Other: Food Product<br>* Each food product will provide similar calories, but a different micro- and macro-nutrient composition<br>|
| Experimental: Food Product 3<br>Experimental 1 | Other: Food Product<br>* Each food product will provide similar calories, but a different micro- and macro-nutrient composition<br>|
| Experimental: Food Product 4<br>Experimental 2 | Other: Food Product<br>* Each food product will provide similar calories, but a different micro- and macro-nutrient composition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Compare change in baseline and 4 weeks | 
| Change in Inflammatory Markers | Measured by immunoassay | Compare change in baseline and 4 weeks |