NCT04427462

Brief Summary

This research study is about how daily activities, behaviors, and fitness affect the health and function of blood cells and their mitochondria, which are the powerhouses of the cells. These small mitochondria inside the cells make energy, and are very important for the health of the body.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 10, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

February 7, 2025

Status Verified

September 1, 2024

Enrollment Period

4.8 years

First QC Date

April 10, 2020

Last Update Submit

February 5, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old.

    Platelet mitochondrial respiration from isolated platelets will be measured using a flux analyzer. Adiposity will be measured with dual X-ray absorptiometry, and peak aerobic capacity with an incremental cycle ergometer test. measure physical activity

    8 days

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

8-10 year olds

You may qualify if:

  • Ages 8-10 years Boys and girls All ethnicity All BMI

You may not qualify if:

  • severe persistent asthma exercise induced asthma autism spectrum disorder attention deficit hyperactivity disorder attention deficit disorder
  • Opposition defiant disorder
  • conduct disorder
  • epilepsy
  • chronic kidney disease
  • hormonal disease
  • autoimmune diseases
  • bleeding disorders
  • chronic infections
  • mental health disorder
  • Type 2 and Type 1 diabetes
  • Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, saliva, and stool will be collected.

Study Officials

  • Elisabet Borsheim, Ph

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonja C Nolen, MS

CONTACT

501-364-3309acncstudies@archildrens.org

Audrey Martinez, MS, RD, LD

CONTACT

501-364-3309acncstudies@archildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

June 11, 2020

Study Start

September 1, 2020

Primary Completion

July 1, 2025

Study Completion

June 1, 2026

Last Updated

February 7, 2025

Record last verified: 2024-09

Locations

US(1)