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

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ClinicalTrials.gov Identifier: NCT04819308
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Arkansas

Study Description
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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
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
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Study Type : Observational
Estimated 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 : March 18, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 30, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Substrate Oxidation [ Time Frame: 24 months ]
    Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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: 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819308


Contacts
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Contact: Elizabeth Hayes, BS 5013643309 acncstudies@archildrens.org
Contact: Ashton Adkison, BS 5013643309 acncstudies@archildrens.org

Locations
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United States, Arkansas
Arkansas Children's Nutrition Center Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Ashton Adkison, BS    501-364-3309    acncstudies@archildrens.org   
Sponsors and Collaborators
University of Arkansas
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Elisabet Borsheim, PhD Arkansas Children's Hospital Research Institute
More Information
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04819308    
Other Study ID Numbers: 261146
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arkansas:
Children
Kids
Physical Activity
Exercise
Substrate Oxidation
 Fat Oxidation
Carbohydrate Oxidation
Fitness
Nutrient
Obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight