High-fat Meal Challenge in Pediatrics
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High-fat Metabolic Challenge Participants will consume a high-fat agent one time, at the second study visit. |
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.
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Outcome Measures
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. [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 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 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
- 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.
Other Outcome Measures
- Assess if fatty acid oxidation mediates the correlation between VO2 max and a continuous metabolic syndrome score. [Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Children ages 8-17 years with a BMI-percentile ≥ 5th.
Exclusion Criteria:
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Previous diagnosis of type 1 or 2 diabetes.
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Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
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Evidence of inherited disorders of lipid metabolism.
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Inability to participant in the maximal aerobic capacity test on the treadmill.
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Allergies to palm oils or protein types within high-fat challenge, such as lactose and soy.
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Individuals who cannot speak and/or write in English.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Health | Lebanon | New Hampshire | United States | 03766 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY02001316