Assessment of a New Food Product in Metabolically at Risk Children

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

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).

Study Overview

• Status: Completed
• Conditions: Inflammation; Cardiovascular Risk Factor; Micronutrient Deficiency
• Intervention / Treatment: Other: Food Product

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Department of Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Carl L Keen, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): March 24, 2018
• Study Completion (Actual): May 24, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 1009239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No