HealthyNCT04408833
Palmitate Study: A Method Study of Dietary Lipid Oxidation in Toddlers
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. Read more about this study
- Who is it for?
- Ages 23 to 25 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 23 to 25 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 10 toddlers approximately two years of age from ongoing studies or as a new participant from the community
Who may be able to join
- Healthy
- Male or female
- Toilet trained or not
Who cannot join
- Diagnosed metabolic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.
Read the detailed description
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
How toddlers burn fat
collect urine
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start21 Aug 2020
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (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
- 10 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, PhD, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408833
- Sponsor's protocol ID
- 249922
- Status last verified
- Jan 2025
- First submitted
- 26 May 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
- Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study
- ClinicalTrials.gov ID
- NCT04408833
- Acronym / sponsor ID
- 249922
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 29 May 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.
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.
Detailed description
The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 25 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 10 toddlers approximately two years of age from ongoing studies or as a new participant from the community
Key inclusion criteria (3 listed)
- Healthy
- Male or female
- Toilet trained or not
Key exclusion criteria (1 listed)
- Diagnosed metabolic 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
How toddlers burn fat
Time frame: 24 hours
collect urine
Results and safety
This study is still under way. Results are not available in the source record yet.
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, PhD principal investigator
Arkansas Children's Research Institute
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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
How toddlers burn fat (time frame: 24 hours). 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.