Assessment of a New Food Product in Metabolically at Risk Children

NCT ID: NCT03175003

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2018-05-24

Brief 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).

Detailed 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.

Conditions

Cardiovascular Risk Factor; Inflammation; Micronutrient Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Food Product 1

Macronutrient similar to experimental, micronutrient lower than experimental

Group Type: ACTIVE_COMPARATOR

Food Product

Intervention Type: OTHER

Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Food Product 2

Macronutrient lower than experimental, micronutrient similar to experimental

Group Type: ACTIVE_COMPARATOR

Food Product

Intervention Type: OTHER

Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Food Product 3

Experimental 1

Group Type: EXPERIMENTAL

Food Product

Intervention Type: OTHER

Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Food Product 4

Experimental 2

Group Type: EXPERIMENTAL

Food Product

Intervention Type: OTHER

Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Interventions

Food Product

Each food product will provide similar calories, but a different micro- and macro-nutrient composition

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl L Keen, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Department of Nutrition

Davis, California, United States

Countries

United States

Other Identifiers

1009239

Identifier Type: -

Identifier Source: org_study_id