HealthyMI EnergyNCT04427462
Bioenergetic Phenotypes and Cardiometabolic Health
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to Jun 2026
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 8-10 year olds
Who may be able to join
- Ages 8-10 years Boys and girls All ethnicity All BMI
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72203
Tonja Nolen, MS, 501-364-2853, acncstudies@archildrens.org
About this study
Official title: Linking Bioenergetic Phenotypes in Circulating Cells with Cardiometabolic Health in School-age Children
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.
Read the detailed 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).
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Sep 2020
- Primary completionJul 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, Ph, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427462
- Sponsor's protocol ID
- 260376
- Acronym
- MI Energy
- Status last verified
- Sep 2024
- First submitted
- 10 Apr 2020
- Last updated
- 7 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Bioenergetic Phenotypes in Circulating Cells with Cardiometabolic Health in School-age Children
- ClinicalTrials.gov ID
- NCT04427462
- Acronym / sponsor ID
- MI Energy / 260376
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Jun 2020 (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.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 8-10 year olds
Key inclusion criteria (1 listed)
- Ages 8-10 years Boys and girls All ethnicity All BMI
Key exclusion criteria (12 listed)
- 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
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
Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old.
Time frame: 8 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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, Ph principal investigator
Arkansas Children's Nutrition Center
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 Healthy, 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 1 inclusion and 12 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 7 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?
Contact Tonja C Nolen, MS (501-364-3309, acncstudies@archildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old. (time frame: 8 days). 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 7 Feb 2025.