Assessment of a New Food Product in Metabolically at Risk Children

NCT03175003 | Completed

• 1 other identifier: 1009239
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Risk Factor; Inflammation; Micronutrient Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Metabolome

  Compare change in baseline and 4 weeks

• Change in Lipidome

  Compare change in baseline and 4 weeks

• Change in Inflammatory Markers

  Compare change in baseline and 4 weeks

Study Arms (4)

Food Product 1

ACTIVE COMPARATOR

Macronutrient similar to experimental, micronutrient lower than experimental

Other: Food Product

Food Product 2

ACTIVE COMPARATOR

Macronutrient lower than experimental, micronutrient similar to experimental

Other: Food Product

Food Product 3

EXPERIMENTAL

Experimental 1

Other: Food Product

Food Product 4

EXPERIMENTAL

Experimental 2

Other: Food Product

Interventions

Food Product OTHER

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

Food Product 1; Food Product 2; Food Product 3; Food Product 4

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Department of Nutrition

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Food

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Carl L Keen, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Products will look and taste similar, and will be provided in coded packaging
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, controlled, 4 parallel arm design

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: June 5, 2017
• Study Start: June 15, 2017
• Primary Completion: March 24, 2018
• Study Completion: May 24, 2018
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)