Pediatric ObesityNCT05230433
High-fat Meal Challenge in Pediatrics
A study testing High-fat Challenge in people with Pediatric Obesity and Insulin Resistance, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years). Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Insulin Resistance
- What is being tested?
- High-fat Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 8-17 years with a BMI-percentile ≥ 5th.
Who cannot join
- Previous diagnosis of type 1 or 2 diabetes.
- Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
- Evidence of inherited disorders of lipid metabolism.
- Inability to participant in the maximal aerobic capacity test on the treadmill.
- Allergies to palm oils or protein types within high-fat challenge, such as lactose and soy.
- Individuals who cannot speak and/or write in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications of Insulin Resistance and Cardiorespiratory Fitness in the Metabolic Response to a High-fat Meal Challenge in Pediatrics
The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years). Ability to metabolize the meal will be assessed by profiling mitochondrial and extra-mitochondrial fatty acid metabolites. The investigators will test if fatty acid oxidation mediates the relationship between fitness and markers of metabolic health, such as insulin resistance.
- Conditions
- Pediatric Obesity, Insulin Resistance
- Being tested
- High-fat Challenge
- Medical subject headings
- Pediatric Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat ChallengeDietary supplement
The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.
| Study group | Role | What they receive |
|---|---|---|
| High-fat Metabolic Challenge | Experimental | Participants will consume a high-fat agent one time, at the second study visit. Receives: Dietary Supplement: High-fat Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability of the High Fat Agent.
Determine the number of participants that complete at least 75% of the shake (by weight).
Measured: 10 minutes
Secondary outcomes (3)
BMI Percentile
BMI percentile calculated for each participant. Average and standard deviations were reported.
Measured: At baseline
Medium Chain Acylcarnitine Concentration
Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.
Measured: 60 and 180 minutes post consumption of high fat shake
Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.
Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.
Measured: 60 and 180 minutes post consumption of high fat shake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 May 2022
- Primary completion19 Sep 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer L. Meijer, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230433
- Sponsor's protocol ID
- STUDY02001316
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2022
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Insulin Resistance and Cardiorespiratory Fitness in the Metabolic Response to a High-fat Meal Challenge in Pediatrics
- ClinicalTrials.gov ID
- NCT05230433
- Acronym / sponsor ID
- STUDY02001316
- Conditions
- Pediatric Obesity, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years). Ability to metabolize the meal will be assessed by profiling mitochondrial and extra-mitochondrial fatty acid metabolites. The investigators will test if fatty acid oxidation mediates the relationship between fitness and markers of metabolic health, such as insulin resistance.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-fat Metabolic Challenge | Experimental | Dietary Supplement: High-fat ChallengeParticipants will consume a high-fat agent one time, at the second study visit. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 8-17 years with a BMI-percentile ≥ 5th.
Key exclusion criteria (6 listed)
- Previous diagnosis of type 1 or 2 diabetes.
- Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
- Evidence of inherited disorders of lipid metabolism.
- Inability to participant in the maximal aerobic capacity test on the treadmill.
- Allergies to palm oils or protein types within high-fat challenge, such as lactose and soy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat ChallengeThe shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor. | Dietary supplement | High-fat Metabolic Challenge |
Primary outcome
Palatability of the High Fat Agent.
Time frame: 10 minutes
Determine the number of participants that complete at least 75% of the shake (by weight).
3 secondary outcomes
BMI Percentile
Time frame: At baseline
Medium Chain Acylcarnitine Concentration
Time frame: 60 and 180 minutes post consumption of high fat shake
Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.
Time frame: 60 and 180 minutes post consumption of high fat shake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat Challenge in people with Pediatric Obesity and Insulin Resistance, run by Dartmouth-Hitchcock Medical Center 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 6 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 29 Sep 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?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Palatability of the High Fat Agent. (time frame: 10 minutes). 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 29 Sep 2025.