Assessment of a New Food Product in Metabolically at Risk Children

University of California (UC) Davis

Status: Completed

Conditions: Inflammation; Micronutrient Deficiency; Cardiovascular Risk Factor

Treatments: Other: Food Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03175003

1009239

Details and patient eligibility

About

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).

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 4 patient groups

Food Product 1

Active Comparator group

Description:

Macronutrient similar to experimental, micronutrient lower than experimental

Treatment:

Other: Food Product

Food Product 2

Active Comparator group

Description:

Macronutrient lower than experimental, micronutrient similar to experimental

Treatment:

Other: Food Product

Food Product 3

Experimental group

Description:

Experimental 1

Treatment:

Other: Food Product

Food Product 4

Experimental group

Description:

Experimental 2

Treatment:

Other: Food Product