ObesitySUPERkidsNCT04819308
Differences in Nutrient Use During Exercise Between Children of Varying Body Mass Indices and Fitness Levels
An observational study of Obesity, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children ages 8-11, who have previously participated in the study "MI Energy".
Who may be able to join
- 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)
Show all 10Show fewer
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Children, Kids, Physical Activity, Exercise, Substrate Oxidation, Fat Oxidation, Carbohydrate Oxidation, Fitness, Nutrient, Obesity
- Medical subject headings
- Obesity, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Substrate Oxidation
Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start18 Mar 2021
- Primary completion1 Jul 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, PhD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819308
- Sponsor's protocol ID
- 261146
- Acronym
- SUPERkids
- Status last verified
- Sep 2024
- First submitted
- 25 Mar 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Utilization in Pre-pubertal Children During Submaximal Exercise and Rest ("SUPER Kids")
- ClinicalTrials.gov ID
- NCT04819308
- Acronym / sponsor ID
- SUPERkids / 261146
- Conditions
- Obesity
- Keywords
- Children, Kids, Physical Activity, Exercise, Substrate Oxidation, Fat Oxidation, Carbohydrate Oxidation, Fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children ages 8-11, who have previously participated in the study "MI Energy".
Key inclusion criteria (10 listed)
- Boys or girls
- Ages 8-11 years
- All races
- All ethnicities
- All BMIs
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Substrate Oxidation
Time frame: 24 months
Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Arkansas Children's Nutrition Center webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabet Borsheim, PhD principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substrate Oxidation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.