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

Sponsor

Arkansas Children's Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04819308

Collaborator

(none)

Enrollment

Location

17.4

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 18, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Outcome Measures

Primary Outcome Measures

Substrate Oxidation [24 months]
Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Boys or girls
Ages 8-11 years
All races
All ethnicities
All BMIs
Children who completed a DXA scan during MI Energy (IRB Protocol: 260376)
Children who completed a fitness test during MI Energy (IRB Protocol: 260376) and achieved 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:

study:

1. 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
1. 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
1. 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.