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OpenTrials
Completed

NCT Number: NCT05230433

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.

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Key information

Conditions

Pediatric Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Health

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-fat Challenge

Dietary 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. BMI Percentile

    Time frame: At baseline

    BMI percentile calculated for each participant. Average and standard deviations were reported.

  2. Medium Chain Acylcarnitine Concentration

    Time frame: 60 and 180 minutes post consumption of high fat shake

    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.

  3. Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.

    Time frame: 60 and 180 minutes post consumption of high fat shake

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Implications of Insulin Resistance and Cardiorespiratory Fitness in the Metabolic Response to a High-fat Meal Challenge in Pediatrics

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 9, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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