NCT03175003

Assessment of a New Food Product in Metabolically at Risk Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 9 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Risk Factor
• Inflammation
• Micronutrient Deficiency

Interventions

Type	Name	Description
OTHER	Food Product	Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Timeline

• Start date: 2017-06-15
• Primary completion: 2018-03-24
• Completion: 2018-05-24
• First posted: 2017-06-05
• Last updated: 2019-05-30

Locations

1 site across 1 country: United States