High-fat Meal Challenge in Pediatrics

NCT05230433 | Completed Results

• 1 other identifier: STUDY02001316
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Palatability of the High Fat Agent.

  Determine the number of participants that complete at least 75% of the shake (by weight).

  10 minutes

Secondary Outcomes (3)

• BMI Percentile

  At baseline

• Medium Chain Acylcarnitine Concentration

  60 and 180 minutes post consumption of high fat shake

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

  60 and 180 minutes post consumption of high fat shake

Study Arms (1)

High-fat Metabolic Challenge

EXPERIMENTAL

Participants will consume a high-fat agent one time, at the second study visit.

Dietary Supplement: High-fat Challenge

Interventions

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.

High-fat Metabolic Challenge

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 8-17 years with a BMI-percentile ≥ 5th.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Health

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jennifer Meijer
• Organization: Happy Trails Nutrition

jen@htnutrition.com

6036505250

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Scientist

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 9, 2022
• Study Start: May 1, 2022
• Primary Completion: September 19, 2022
• Study Completion: December 31, 2023
• Last Updated: September 29, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)