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Assessment of a New Food Product in Metabolically at Risk Children

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ClinicalTrials.gov Identifier: NCT03175003
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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).

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Inflammation Micronutrient Deficiency Other: Food Product Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, controlled, 4 parallel arm design
Masking: Double (Participant, Investigator)
Masking Description: Products will look and taste similar, and will be provided in coded packaging
Primary Purpose: Prevention
Official Title: Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : January 29, 2028
Estimated Study Completion Date : January 29, 2028

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




Primary Outcome Measures :
  1. Change in Microvascular Function [ Time Frame: 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 :
  1. Change in Metabolome [ Time Frame: Compare change in baseline and 4 weeks ]
    Measured with Nuclear Magnetic Resonance (NMR)

  2. Change in Lipidome [ Time Frame: Compare change in baseline and 4 weeks ]
    Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry

  3. Change in Inflammatory Markers [ Time Frame: Compare change in baseline and 4 weeks ]
    Measured by immunoassay



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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175003


Contacts
Contact: Carl L Keen, PhD 530-752-6331 clkeen@ucdavis.edu

Locations
United States, California
Department of Nutrition Recruiting
Davis, California, United States, 95616
Contact: Roberta R Holt, PhD    530-752-4950    rrholt@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Carl L Keen, PhD Principal Investigator

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03175003     History of Changes
Other Study ID Numbers: 1009239
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs