Examining the Relationship Between Acute Meal Intake and Inflammation in Children

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Completed

CT.gov ID

NCT03597542

Collaborator

Egg Nutrition Center (Other)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Inflammation	Other: Eggs and Carbohydrates	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double blind randomized cross-over designDouble blind randomized cross-over design

Masking:

Double (Participant, Investigator)

Masking Description:

Both the participants and researchers involved with data analysis will be blinded to which condition given.

Primary Purpose:

Basic Science

Official Title:

Examining the Relationship Between Acute Meal Intake and Inflammation in Children

Actual Study Start Date :

Aug 29, 2017

Actual Primary Completion Date :

Feb 2, 2018

Actual Study Completion Date :

Feb 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maltodextrin Participants will consume 56g of maltodextrin dissolved in 500mL of water.	Other: Eggs and Carbohydrates 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.
Experimental: Egg Participants will consume 36g of spray-dried egg powder (equivalent to 3 eggs) dissolved in 500mL of water.	Other: Eggs and Carbohydrates 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

Intervention/Treatment

Experimental: Maltodextrin

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

Other: Eggs and Carbohydrates

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.

Experimental: Egg

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

Other: Eggs and Carbohydrates

Outcome Measures

Primary Outcome Measures

Effects of egg or maltodextrin on inflammatory cytokines (Tumor necrosis factor-alpha, C-reactive protein, and Interleukin-6) [3 weeks.]
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. [3 weeks.]
Will be used by determining the cells per microliter of lysed whole blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Urbana-Champaign	Urbana	Illinois	United States	61801

Sponsors and Collaborators

University of Illinois at Urbana-Champaign
Egg Nutrition Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naiman Khan, Assistant Professor, University of Illinois at Urbana-Champaign

ClinicalTrials.gov Identifier:

NCT03597542

Other Study ID Numbers:

17112

First Posted:

Jul 24, 2018

Last Update Posted:

Jul 31, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Naiman Khan, Assistant Professor, University of Illinois at Urbana-Champaign

Children

Inflammation

Obesity

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Jul 31, 2018