An interventional study of Food Product in Cardiovascular Risk Factor, Inflammation and Micronutrient Deficiency, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by University of California, Davis · Not applicable, Interventional, and Prevention
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).
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 68 is above the median of 50 across 2,436 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Macronutrient similar to experimental, micronutrient lower than experimental
Other: Food Product
Macronutrient lower than experimental, micronutrient similar to experimental
Other: Food Product
Experimental 1
Other: Food Product
Experimental 2
Other: Food Product
Each food product will provide similar calories, but a different micro- and macro-nutrient composition
Change in Microvascular Function
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
Change in Metabolome
Measured with Nuclear Magnetic Resonance (NMR)
Time frame: Compare change in baseline and 4 weeks
Change in Lipidome
Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
Time frame: Compare change in baseline and 4 weeks
Change in Inflammatory Markers
Measured by immunoassay
Time frame: Compare change in baseline and 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University of California, Davis