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High-fat Meal Challenge in Pediatrics

Primary Purpose

Pediatric Obesity, Insulin Resistance

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-fat Challenge
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pediatric Obesity

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dartmouth-Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-fat Metabolic Challenge

Arm Description

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

Outcomes

Primary Outcome Measures

Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by daily physical activity.
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Over seven days, participants will be asked to wear an ActiGraph accelerometer (ActiGraph, Pensacola, FL) and complete three dietary recalls. Analysis: Daily time spent in moderate to vigorous physical activity will be calculated (minutes). The average daily time in moderate to vigorous physical activity will be calculated across 7 days (minutes).
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by daily dietary intake.
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Over seven days, participants will be asked to wear an ActiGraph accelerometer (ActiGraph, Pensacola, FL) and complete three dietary recalls. Analysis: Daily dietary intake will be scored using the Healthy Eating Index (scale: 1-12). The average Healthy Eating Index score will be calculated across the 3 days of collected data (scale: 1-12)
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by VO2 max.
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Stress testing will use a modified Bruce protocol, increasing in elevation and speed, to measure maximal oxygen consumption (VO2 max). VO2 max describes the milliliters of oxygen consumed in one minute of exercise, per kilogram of body weight (units: mL/min/kg).
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by body composition.
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Body composition will be measured using bioelectrical impedance (Seca, Hamburg, Germany). Percent fat mass will be calculated (%) Analysis: Investigators will determine if the interaction between daily physical activity (minutes) and daily dietary intake (score: 1-12) mediates the correlation between VO2 max (mL/min/kg) and body fat percentage (%). Outcome units will describe a linear correlation.

Secondary Outcome Measures

Assess the correlation between fatty acid oxidation and VO2 max.
Protocol: After an overnight fast, participants will consume the high-fat (HF) challenge, composed of palm oil supplemented Boost® (15% kcal carbohydrates, 15% kcal protein, 70% kcal lipid). Blood will be sampled via intravenous line at baseline (0 minutes) and after consuming the challenge (30, 60, 120, and 180 minutes). The investigators will conduct targeted metabolomics on all blood samples, profiling acylcarnitines (AC) and dicarboxylic fatty acid (FA-COOH) metabolites. Analysis: Longitudinal trajectories, measured by empirical Bayes time-series analysis, will quantify the response of metabolites to the challenge. Mixed regression models will determine the correlation between VO2 max (mL/min/kg) and metabolite trajectories. Outcome units will describe a linear correlation.

Full Information

First Posted
January 6, 2022
Last Updated
September 19, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05230433
Brief Title
High-fat Meal Challenge in Pediatrics
Official Title
Implications of Insulin Resistance and Cardiorespiratory Fitness in the Metabolic Response to a High-fat Meal Challenge in Pediatrics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-fat Metabolic Challenge
Arm Type
Experimental
Arm Description
Participants will consume a high-fat agent one time, at the second study visit.
Intervention Type
Dietary Supplement
Intervention Name(s)
High-fat Challenge
Intervention Description
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 Outcome Measure Information:
Title
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by daily physical activity.
Description
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Over seven days, participants will be asked to wear an ActiGraph accelerometer (ActiGraph, Pensacola, FL) and complete three dietary recalls. Analysis: Daily time spent in moderate to vigorous physical activity will be calculated (minutes). The average daily time in moderate to vigorous physical activity will be calculated across 7 days (minutes).
Time Frame
Up to 7 days
Title
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by daily dietary intake.
Description
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Over seven days, participants will be asked to wear an ActiGraph accelerometer (ActiGraph, Pensacola, FL) and complete three dietary recalls. Analysis: Daily dietary intake will be scored using the Healthy Eating Index (scale: 1-12). The average Healthy Eating Index score will be calculated across the 3 days of collected data (scale: 1-12)
Time Frame
Up to 7 days
Title
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by VO2 max.
Description
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Stress testing will use a modified Bruce protocol, increasing in elevation and speed, to measure maximal oxygen consumption (VO2 max). VO2 max describes the milliliters of oxygen consumed in one minute of exercise, per kilogram of body weight (units: mL/min/kg).
Time Frame
Up to 7 days
Title
Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by body composition.
Description
Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Body composition will be measured using bioelectrical impedance (Seca, Hamburg, Germany). Percent fat mass will be calculated (%) Analysis: Investigators will determine if the interaction between daily physical activity (minutes) and daily dietary intake (score: 1-12) mediates the correlation between VO2 max (mL/min/kg) and body fat percentage (%). Outcome units will describe a linear correlation.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Assess the correlation between fatty acid oxidation and VO2 max.
Description
Protocol: After an overnight fast, participants will consume the high-fat (HF) challenge, composed of palm oil supplemented Boost® (15% kcal carbohydrates, 15% kcal protein, 70% kcal lipid). Blood will be sampled via intravenous line at baseline (0 minutes) and after consuming the challenge (30, 60, 120, and 180 minutes). The investigators will conduct targeted metabolomics on all blood samples, profiling acylcarnitines (AC) and dicarboxylic fatty acid (FA-COOH) metabolites. Analysis: Longitudinal trajectories, measured by empirical Bayes time-series analysis, will quantify the response of metabolites to the challenge. Mixed regression models will determine the correlation between VO2 max (mL/min/kg) and metabolite trajectories. Outcome units will describe a linear correlation.
Time Frame
Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day
Other Pre-specified Outcome Measures:
Title
Assess if fatty acid oxidation mediates the correlation between VO2 max and a continuous metabolic syndrome score.
Description
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.
Time Frame
Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Dartmouth-Health
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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High-fat Meal Challenge in Pediatrics

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