High-fat Meal Challenge in Pediatrics

NCT ID: NCT05230433

Last Updated: 2025-09-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Obesity Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High-fat Metabolic Challenge

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

Group Type EXPERIMENTAL

High-fat Challenge

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jennifer L. Meijer

Principal Investigator; Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth-Health

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY02001316

Identifier Type: -

Identifier Source: org_study_id

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