Back to resultsAssessment of a New Food Product in Metabolically at Risk Children
Primary Purpose
Cardiovascular Risk Factor, Inflammation, Micronutrient Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Product
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Risk Factor
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.
Sites / Locations
- Department of Nutrition
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Food Product 1
Food Product 2
Food Product 3
Food Product 4
Arm Description
Macronutrient similar to experimental, micronutrient lower than experimental
Macronutrient lower than experimental, micronutrient similar to experimental
Experimental 1
Experimental 2
Outcomes
Primary Outcome Measures
Change in Microvascular Function
Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values
Secondary Outcome Measures
Change in Metabolome
Measured with Nuclear Magnetic Resonance (NMR)
Change in Lipidome
Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
Change in Inflammatory Markers
Measured by immunoassay
Full Information
NCT ID
NCT03175003
First Posted
February 13, 2017
Last Updated
May 28, 2019
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03175003
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
March 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Inflammation, Micronutrient Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, controlled, 4 parallel arm design
Masking
ParticipantInvestigator
Masking Description
Products will look and taste similar, and will be provided in coded packaging
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food Product 1
Arm Type
Active Comparator
Arm Description
Macronutrient similar to experimental, micronutrient lower than experimental
Arm Title
Food Product 2
Arm Type
Active Comparator
Arm Description
Macronutrient lower than experimental, micronutrient similar to experimental
Arm Title
Food Product 3
Arm Type
Experimental
Arm Description
Experimental 1
Arm Title
Food Product 4
Arm Type
Experimental
Arm Description
Experimental 2
Intervention Type
Other
Intervention Name(s)
Food Product
Intervention Description
Each food product will provide similar calories, but a different micro- and macro-nutrient composition
Primary Outcome Measure Information:
Title
Change in Microvascular Function
Description
Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values
Time Frame
Compare change in baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in Metabolome
Description
Measured with Nuclear Magnetic Resonance (NMR)
Time Frame
Compare change in baseline and 4 weeks
Title
Change in Lipidome
Description
Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
Time Frame
Compare change in baseline and 4 weeks
Title
Change in Inflammatory Markers
Description
Measured by immunoassay
Time Frame
Compare change in baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl L Keen, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of a New Food Product in Metabolically at Risk Children
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