Assessment of a New Food Product in Metabolically at Risk Children

Completed · Not applicable

Conditions studied: Cardiovascular Risk Factor, Inflammation, Micronutrient Deficiency

In brief

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).

Key facts

Study ID

NCT03175003

Run by

University of California, Davis

People needed

68

Starts

2017-06-15

Expected to finish

2018-05-24

Last updated by the study team

2019-05-30

Who can join

Age: 9 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Department of Nutrition — Davis, California, United States

Full record on ClinicalTrials.gov

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