Urbana, Illinois 61801

  • Inflammation

Purpose:

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.


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


Study is Available At:


Original ID:

17112


NCT ID:

NCT03597542


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

7 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Illinois at Urbana-Champaign


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Study Dates

Start Date:August 29, 2017
Completion Date:February 2, 2018
Completion Type:Actual
Primary Completion Date:February 2, 2018
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 28, 2018
First Received Date:July 13, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Effects of egg or maltodextrin on inflammatory monocyte cells with and without expression of Toll-like receptor 4 and C-C Chemokine receptor-2.
Time Frame:3 weeks.
Safety Issues:False
Description:Will be used by determining the cells per microliter of lysed whole blood.
Outcome Type:Primary Outcome
Measure:Effects of egg or maltodextrin on inflammatory cytokines (Tumor necrosis factor-alpha, C-reactive protein, and Interleukin-6)
Time Frame:3 weeks.
Safety Issues:False
Description:Will be used by determining any changes in inflammatory cytokines via enzyme-linked immunosorbent assay (ELISA) kits.

Study Interventions

Intervention Type:Other
Name:Eggs and Carbohydrates
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.
Arm Name:Maltodextrin

Study Arms

Study Arm Type:Experimental
Arm Name:Egg
Description:Participants will consume 36g of spray-dried egg powder (equivalent to 3 eggs) dissolved in 500mL of water.
Study Arm Type:Experimental
Arm Name:Maltodextrin
Description:Participants will consume 56g of maltodextrin dissolved in 500mL of water.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Illinois at Urbana-Champaign
Agency Class:Other
Agency Type:Collaborator
Agency Name:Egg Nutrition Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

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