High-fat Meal Challenge in Pediatrics

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Pediatric Obesity
• Intervention / Treatment: Dietary supplement: High-fat Challenge

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-fat Metabolic Challenge; Participants will consume a high-fat agent one time, at the second study visit.	Dietary supplement: High-fat Challenge; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability of the High Fat Agent.	Determine the number of participants that complete at least 75% of the shake (by weight).	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI Percentile	BMI percentile calculated for each participant. Average and standard deviations were reported.	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.	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.	60 and 180 minutes post consumption of high fat shake

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if fatty acid oxidation mediates the correlation between VO2 max and a continuous metabolic syndrome score.	Protocol: The investigators will use fasting blood samples to measure insulin, glucose, lipoproteins, triglycerides, and blood pressure. Analysis: A continuous metabolic score (cMetS) will be calculated composed of insulin, glucose, meal arterial blood pressure, HDL-C, and triglycerides. All of these components will be combined into one measure (score, no units). The investigators will determine if longitudinal trajectories of fatty acid metabolites mediate the correlation between VO2 max (mL/min/kg) and the cMetS score. Outcome units will describe a linear correlation.	Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 19, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Insulin Resistance; Pediatric Obesity
• Other Study ID Numbers: STUDY02001316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No