Department of Nutrition
Davis, California, 95616, United States
NCT Number: NCT03175003
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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Notify Me9 year–13 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each food product will provide similar calories, but a different micro- and macro-nutrient composition
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
Time frame: Compare change in baseline and 4 weeks
Measured with Nuclear Magnetic Resonance (NMR)
Time frame: Compare change in baseline and 4 weeks
Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
Time frame: Compare change in baseline and 4 weeks
Measured by immunoassay
University of California, Davis
Other
Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
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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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