HealthyNCT02414867
Total Energy Expenditure and Fat Oxidation in 2 Year Old Children
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children. Read more about this study
- Who is it for?
- Ages 2 to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2017
- 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 2 to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 120 toddlers born from mothers of the Glowing study (NCT01131117)
Who may be able to join
- 1.5-2.5 years of age
- Mother is a participant of the Glowing study (NCT01131117)
- Healthy without taking medication that can affect study outcomes, as determined by the PI
Who cannot join
- None listed
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal weight mothers | |
| 2 | Overweight/Obese mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine total energy expenditure in 2 year old children
Doubly labeled water is administered to 2 year old children and urine is collected at different time points.
Measured: 15 days
To determine fat oxidation in 2 year old children
Deuterated palmitate is administered and urine is collected at different time points.
Measured: 2-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionDec 2017
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
- 16 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 Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414867
- Sponsor's protocol ID
- 203770
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2015
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Energy Expenditure and Fat Oxidation in 2 Year Old Children
- ClinicalTrials.gov ID
- NCT02414867
- Acronym / sponsor ID
- 203770
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Apr 2015 (estimated)
- 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.
The purpose of the study is to determine energy expenditure and fat oxidation in 2 year old children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Normal weight mothers |
| 2 | – | –Overweight/Obese mothers |
Who may qualify
- Ages
- 2 to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 120 toddlers born from mothers of the Glowing study (NCT01131117)
Key inclusion criteria (3 listed)
- 1.5-2.5 years of age
- Mother is a participant of the Glowing study (NCT01131117)
- Healthy without taking medication that can affect study outcomes, as determined by the PI
Key exclusion criteria (1 listed)
- None listed
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
To determine total energy expenditure in 2 year old children
Time frame: 15 days
Doubly labeled water is administered to 2 year old children and urine is collected at different time points.
To determine fat oxidation in 2 year old children
Time frame: 2-6 hours
Deuterated palmitate is administered and urine is collected at different time points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 25 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine total energy expenditure in 2 year old children (time frame: 15 days). The study lists 2 primary outcomes in all. 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 Nov 2024.