High-fat Meal Challenge in Pediatrics

Not Applicable

Completed

• Conditions: Pediatric Obesity; Insulin Resistance
• Interventions: Dietary Supplement: High-fat Challenge

• Registration Number: NCT05230433
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-09
• Study Start: 2022-05-01
• Primary Completion: 2022-09-19
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-fat Metabolic Challenge	High-fat Challenge	Participants will consume a high-fat agent one time, at the second study visit.

Primary Outcome Measures

Name	Time	Method
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.	Up to 7 days	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 daily physical activity.	Up to 7 days	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 VO2 max.	Up to 7 days	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.	Up to 7 days	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

Name	Time	Method
Assess the correlation between fatty acid oxidation and VO2 max.	Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day	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.

Trial Locations

Locations (1)

Dartmouth-Health; 🇺🇸 Lebanon, New Hampshire, United States