NCT04819308

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

September 1, 2024

Enrollment Period

3.3 years

First QC Date

March 25, 2021

Last Update Submit

February 24, 2025

Conditions

Keywords

ChildrenKidsPhysical ActivityExerciseSubstrate OxidationFat OxidationCarbohydrate OxidationFitnessNutrientObesity

Outcome Measures

Primary Outcomes (1)

  • Substrate Oxidation

    Carbohydrate oxidation and fatty acid oxidation quantified using breath samples measured by indirect calorimetry

    24 months

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Elisabet Borsheim, PhD

    Arkansas Children's Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 26, 2021

Study Start

March 18, 2021

Primary Completion

July 1, 2024

Study Completion

December 1, 2025

Last Updated

February 25, 2025

Record last verified: 2024-09

Locations