Assessment of a New Food Product in Metabolically at Risk Children

Not Applicable

Completed

Conditions: Inflammation
Cardiovascular Risk Factor
Micronutrient Deficiency

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Food Product 2	Food Product	Macronutrient lower than experimental, micronutrient similar to experimental
Food Product 1	Food Product	Macronutrient similar to experimental, micronutrient lower than experimental
Food Product 3	Food Product	Experimental 1
Food Product 4	Food Product	Experimental 2

Primary Outcome Measures

Name	Time	Method
Change in Microvascular Function	Compare change in baseline and 4 weeks	Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values

Secondary Outcome Measures

Name	Time	Method
Change in Lipidome	Compare change in baseline and 4 weeks	Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
Change in Inflammatory Markers	Compare change in baseline and 4 weeks	Measured by immunoassay
Change in Metabolome	Compare change in baseline and 4 weeks	Measured with Nuclear Magnetic Resonance (NMR)

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial