Examining the Relationship Between Acute Meal Intake and Inflammation in Children
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Aug 2017
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2018
CompletedFirst Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2018
CompletedJuly 31, 2018
July 1, 2018
5 months
July 13, 2018
July 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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.
3 weeks.
Study Arms (2)
Maltodextrin
EXPERIMENTALParticipants will consume 56g of maltodextrin dissolved in 500mL of water.
Egg
EXPERIMENTALParticipants will consume 36g of spray-dried egg powder (equivalent to 3 eggs) dissolved in 500mL of water.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Between the ages of 7-17
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Urbana-Champaignlead
- Egg Nutrition Centercollaborator
Study Sites (1)
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801, United States
Related Publications (1)
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.
PMID: 31825075DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Both the participants and researchers involved with data analysis will be blinded to which condition given.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 13, 2018
First Posted
July 24, 2018
Study Start
August 29, 2017
Primary Completion
February 2, 2018
Study Completion
February 2, 2018
Last Updated
July 31, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share