Examining the Relationship Between Acute Meal Intake and Inflammation in Children

Obesity Clinical Trial

Official title:

Examining the Relationship Between Acute Meal Intake and Inflammation in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597542
• Other study ID #: 17112
• Status: Completed
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: July 2018
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks.
Secondary	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.	3 weeks.