Assessment of a New Food Product in Metabolically at Risk Children

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175003
• Other study ID #: 1009239
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 24, 2018
• Est. primary completion date: March 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Inflammation
• Micronutrient Deficiency

Intervention

Other:
• Food Product
Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Locations

Country	Name	City	State
United States	Department of Nutrition	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Microvascular Function	Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values	Compare change in baseline and 4 weeks
Secondary	Change in Metabolome	Measured with Nuclear Magnetic Resonance (NMR)	Compare change in baseline and 4 weeks
Secondary	Change in Lipidome	Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry	Compare change in baseline and 4 weeks
Secondary	Change in Inflammatory Markers	Measured by immunoassay	Compare change in baseline and 4 weeks