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OpenTrials
Completed

NCT Number: NCT03597542

Examining the Relationship Between Acute Meal Intake and Inflammation in Children

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eggs and Carbohydrates

Other

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 outcomes

  1. Effects of egg or maltodextrin on inflammatory cytokines (Tumor necrosis factor-alpha, C-reactive protein, and Interleukin-6)

    Time frame: 3 weeks.

    Will be used by determining any changes in inflammatory cytokines via enzyme-linked immunosorbent assay (ELISA) kits.

Secondary outcomes

  1. 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.

    Will be used by determining the cells per microliter of lysed whole blood.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Egg Nutrition Center

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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