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OpenTrials
Completed

NCT Number: NCT03175003

Assessment of a New Food Product 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).

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Key information

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food Product

Other

Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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