Differences in Nutrient Use During Exercise Between Children of Varying Body Mass Indices and Fitness Levels (SUPERkids)

July 5, 2023 updated by: Arkansas Children's Hospital Research Institute

Substrate Utilization in Pre-pubertal Children During Submaximal Exercise and Rest ("SUPER Kids")

Children who have previously participated in the study "MI Energy" will be invited to participate in "SUPER kids". Investigators want to better understand differences in nutrient use (e.g., fatty acid and carbohydrate) during rest and exercise in children of varying body types and activity levels.

Study Overview

Status

Recruiting

Conditions

Detailed Description

We will examine fatty acid oxidation (FAO) and carbohydrate (CHO) oxidation at rest and during exercise in children of all body types and activity levels.

Children 8-11 years old who have done the "MI Energy" study will participate. Up to 80 children will be recruited to participate in this study at Arkansas Children's Nutrition Center (ACNC).

They will be asked to attend three study visits (baseline, and two exercise visits). For the exercise visits, they will follow a diet plan and be encouraged to avoid certain foods and activities.

Children will do two testing days with the following measures:

  • Urine (pee) will be collected
  • Body weight and height
  • Exercise test on the bike - children will ride a stationary bike at a set intensity and at an intensity relative to their previous bike test during the study "MI Energy". The order in which they bike will be random. Before and during biking, children will wear a mask that will measure the gases in their breath and a monitor that will measure heart rate.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Nutrition Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy children ages 8-11, who have previously participated in the study "MI Energy".

Description

Inclusion Criteria:

  • Boys or girls
  • Ages 8-11 years
  • All races
  • All ethnicities
  • All BMIs
  • Children who completed a dual-energy x-ray absorptiometry (DXA) scan during "MI Energy" (IRB Protocol: 260376)
  • Children who completed a fitness test during "MI Energy" (IRB Protocol: 260376) and achieved peak oxygen uptake (VO2 peak)
  • All fitness levels [VO2 peak already determined under "MI Energy" (IRB Protocol: 260376)]
  • Children whose parents consented to the following in the "MI Energy" (IRB Protocol: 260376) study:

A) be contacted about future follow-up studies to "MI Energy", and having the data that is collected about their child in "MI Energy" being used also in these follow-up studies; and B) information collected in the "MI Energy" study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development; and C) any biological samples collected in the "MI Energy" study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development.

Exclusion Criteria:

  • Participants who have been excluded from participation in the study "MI Energy" (IRB Protocol: 260376).
  • Participants whose parents report any change in medical history that may potentially affect participation and/or study outcomes as determined by PI.
  • Participants whose parents report food allergies or intolerances to nuts, wheat, dairy, or eggs.
  • Participants whose parents report unwillingness to follow dietary standardization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substrate Oxidation
Time Frame: 24 months
Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Elisabet Borsheim, PhD, Arkansas Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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