High-fat Meal Challenge in Pediatrics

Insulin Resistance Clinical Trial

Official title:

Implications of Insulin Resistance and Cardiorespiratory Fitness in the Metabolic Response to a High-fat Meal Challenge in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05230433
• Other study ID #: STUDY02001316
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Health	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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).	Up to 7 days
Primary	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)	Up to 7 days
Primary	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).	Up to 7 days
Primary	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.	Up to 7 days
Secondary	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.	Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day