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Examining the Relationship Between Acute Meal Intake and Inflammation in Children

Primary Purpose

Obesity, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eggs and Carbohydrates
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Children, Inflammation, Obesity

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Between the ages of 7-17

Exclusion Criteria:

  • Younger than 7 years and older than 17 years
  • Presence of allergies to eggs and/or sugar substitutes
  • Presence of heart or respiratory disease
  • Presence of uncontrolled hypertension, diabetes
  • Use of anti-inflammatory medications
  • Presence of cancer or metabolic disease

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Maltodextrin

Egg

Arm Description

Participants will consume 56g of maltodextrin dissolved in 500mL of water.

Participants will consume 36g of spray-dried egg powder (equivalent to 3 eggs) dissolved in 500mL of water.

Outcomes

Primary Outcome Measures

Effects of egg or maltodextrin on inflammatory cytokines (Tumor necrosis factor-alpha, C-reactive protein, and Interleukin-6)
Will be used by determining any changes in inflammatory cytokines via enzyme-linked immunosorbent assay (ELISA) kits.

Secondary Outcome Measures

Effects of egg or maltodextrin on inflammatory monocyte cells with and without expression of Toll-like receptor 4 and C-C Chemokine receptor-2.
Will be used by determining the cells per microliter of lysed whole blood.

Full Information

First Posted
July 13, 2018
Last Updated
July 28, 2018
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Egg Nutrition Center
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1. Study Identification

Unique Protocol Identification Number
NCT03597542
Brief Title
Examining the Relationship Between Acute Meal Intake and Inflammation in Children
Official Title
Examining the Relationship Between Acute Meal Intake and Inflammation in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
Egg Nutrition Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Recent evidence has shown that obese and overweight children exhibit states of chronic inflammation. In obese adults, a high carbohydrate meal induces an inflammatory response; however, the effects of a high carbohydrate meal on biomarkers of inflammation has not previously been examined in children. The purpose of this research project is to characterize the inflammatory response to a high carbohydrate versus a low carbohydrate meal in healthy weight, overweight, and obese children (age 7-17 years). After completing informed consent/assent, a Dual-energy X-ray Absorptiometry (DXA) scan, and baseline blood draw on experimental day 1, children will then return to the lab two times to ingest either a high or low carbohydrate beverage followed by post-meal blood collection for a total of 3 blood draws. Biomarkers of inflammation will be analyzed by flow cytometry and enzyme-linked immunosorbent assay (ELISA). Participants will be recruited through various studies through the Neurocognitive Kinesiology Lab/Body Composition and Nutritional Neuroscience Labs as well as through the local Champaign-Urbana community. Data from this project will provide a better understanding of the inflammatory response to different meals in healthy weight, overweight, and obese children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation
Keywords
Children, Inflammation, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double blind randomized cross-over design
Masking
ParticipantInvestigator
Masking Description
Both the participants and researchers involved with data analysis will be blinded to which condition given.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maltodextrin
Arm Type
Experimental
Arm Description
Participants will consume 56g of maltodextrin dissolved in 500mL of water.
Arm Title
Egg
Arm Type
Experimental
Arm Description
Participants will consume 36g of spray-dried egg powder (equivalent to 3 eggs) dissolved in 500mL of water.
Intervention Type
Other
Intervention Name(s)
Eggs and Carbohydrates
Intervention Description
Participants are asked to consume both egg based powder or maltodextrin dissolved in 500mL of water at two different time points at least one week apart. Participants will then submit to a venous blood draw to assess levels of cellular inflammation.
Primary Outcome Measure Information:
Title
Effects of egg or maltodextrin on inflammatory cytokines (Tumor necrosis factor-alpha, C-reactive protein, and Interleukin-6)
Description
Will be used by determining any changes in inflammatory cytokines via enzyme-linked immunosorbent assay (ELISA) kits.
Time Frame
3 weeks.
Secondary Outcome Measure Information:
Title
Effects of egg or maltodextrin on inflammatory monocyte cells with and without expression of Toll-like receptor 4 and C-C Chemokine receptor-2.
Description
Will be used by determining the cells per microliter of lysed whole blood.
Time Frame
3 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Between the ages of 7-17 Exclusion Criteria: Younger than 7 years and older than 17 years Presence of allergies to eggs and/or sugar substitutes Presence of heart or respiratory disease Presence of uncontrolled hypertension, diabetes Use of anti-inflammatory medications Presence of cancer or metabolic disease
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31825075
Citation
Niemiro GM, Chiarlitti NA, Khan NA, De Lisio M. A Carbohydrate Beverage Reduces Monocytes Expressing TLR4 in Children with Overweight or Obesity. J Nutr. 2020 Mar 1;150(3):616-622. doi: 10.1093/jn/nxz294.
Results Reference
derived

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Examining the Relationship Between Acute Meal Intake and Inflammation in Children

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