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

Obesity Clinical Trial

— SUPERkids  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819308
• Other study ID #: 261146
• Status: Recruiting
• Start date: March 18, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: Tonja Larson, BS
• Phone: 5013642853
• Email: NolenTC[@]archildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substrate Oxidation	Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry	24 months

External Links

•   Arkansas Children's Nutrition Center webpage