N/A
N=15
High-fat Meal Challenge in Pediatrics
Pediatric Obesity · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT05230433 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Palatability of the High Fat Agent. — 13 Participants — p=0.15
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-fat Challenge (Dietary_supplement)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Palatability of the High Fat Agent. |
13 | 0.15 |
| SECONDARY BMI Percentile |
70 | 0.65 |
| SECONDARY Medium Chain Acylcarnitine Concentration |
0.055; 0.061 | — |
| SECONDARY Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes. |
0.902 | — |
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). 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.
Eligibility Criteria
Inclusion Criteria
- Children ages 8-17 years with a BMI-percentile ≥ 5th.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05230433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.