NCT03597542

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

July 13, 2018

Last Update Submit

July 28, 2018

Conditions

Keywords

ChildrenInflammationObesity

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

EXPERIMENTAL

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

Other: Eggs and Carbohydrates

Egg

EXPERIMENTAL

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

Other: Eggs and Carbohydrates

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.

EggMaltodextrin

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

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.

MeSH Terms

Conditions

ObesityInflammation

Interventions

EggsCarbohydrates

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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
Model Details: Double blind randomized cross-over design
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

Locations