Mitochondria (MI) Energy - Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children

Healthy Clinical Trial

Official title:

Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427462
• Other study ID #: 260376
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: Tonja C Nolen, MS
• Phone: 501-364-3309
• Email: acncstudies[@]archildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Determine the impact of physical activity and obesity status on circulating cells mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative capacity, mitochondrial number and proton leak).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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