Insulin Resistance, Pediatric Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHigh-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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palatability of the High Fat Agent. | 10 minutes | Determine the number of participants that complete at least 75% of the shake (by weight). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI Percentile | At baseline | BMI percentile calculated for each participant. Average and standard deviations were reported. |
| Medium Chain Acylcarnitine Concentration | 60 and 180 minutes post consumption of high fat shake | Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported. |
| Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes. | 60 and 180 minutes post consumption of high fat shake | Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported. |
Countries
United States
Participant flow
Recruitment details
Enrollment was completed in September 2022 (n=15). Recruitment followed D-H IRB approval. Adolescents (8-17 years) were recruited through the Children's Hospital at Dartmouth Hitchcock (assisted by Dr. Susanne Tanski), the Weight and Wellness Center (assisted by Dr. Auden McClure), and, as needed, through the community. Flyers have been developed by DHMC marketing.
Pre-assignment details
No pre-assignment occurred.
Participants by arm
| Arm | Count |
|---|---|
| High-fat Metabolic Challenge Participants will consume a high-fat agent one time, at the second study visit.
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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | High-fat Metabolic Challenge |
|---|---|
| Age, Continuous | 14 years STANDARD_DEVIATION 3 |
| Body Mass Index | 22.7 kg/m2 STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Palatability of the High Fat Agent.
Determine the number of participants that complete at least 75% of the shake (by weight).
Time frame: 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-fat Metabolic Challenge | Palatability of the High Fat Agent. | 13 Participants |
Comparison: High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \>75% of the shake.p-value: 0.15Chi-squared
Secondary
BMI Percentile
BMI percentile calculated for each participant. Average and standard deviations were reported.
Time frame: At baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-fat Metabolic Challenge | BMI Percentile | 70 percentile | Standard Deviation 24 |
Comparison: Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.p-value: 0.65Pearson Correlation
Secondary
Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes.
Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.
Time frame: 60 and 180 minutes post consumption of high fat shake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-fat Metabolic Challenge | Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes. | 0.902 ratio | Standard Deviation 0.021 |
Secondary
Medium Chain Acylcarnitine Concentration
Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported.
Time frame: 60 and 180 minutes post consumption of high fat shake
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-fat Metabolic Challenge | Medium Chain Acylcarnitine Concentration | Average MC acylcarnitine at 60 minutes | 0.055 mircoM | Standard Deviation 0.015 |
| High-fat Metabolic Challenge | Medium Chain Acylcarnitine Concentration | Average MC acylcarnitine at 180 minutes | 0.061 mircoM | Standard Deviation 0.014 |