Clinical trial NCT03175003: Assessment of a New Food Product in Metabolically at Risk Children
Official title: Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Inflammation
Micronutrient Deficiency
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 68
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, controlled, 4 parallel arm design
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Microvascular Function
timeFrame: Compare change in baseline and 4 weeks
Secondary outcomes:
measure: Change in Metabolome
timeFrame: Compare change in baseline and 4 weeks
measure: Change in Lipidome
timeFrame: Compare change in baseline and 4 weeks
measure: Change in Inflammatory Markers
timeFrame: Compare change in baseline and 4 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: Department of Nutrition
state: California
Study officials:
affiliation: Principal Investigator
name: Carl L Keen, PhD
role: PRINCIPAL_INVESTIGATOR
References: