MedDataX Logo

Examining the Relationship Between Acute Meal Intake and Inflammation in Children

NCT ID: NCT03597542

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2018-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Children Inflammation Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blind randomized cross-over design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Maltodextrin

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

Group Type EXPERIMENTAL

Eggs and Carbohydrates

Intervention Type 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.

Egg

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

Group Type EXPERIMENTAL

Eggs and Carbohydrates

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Egg Nutrition Center

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Naiman Khan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31825075 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17112

Identifier Type: -

Identifier Source: org_study_id