Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.
Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Prescribed low carbohydrate diet with set recipes
Diet with less than 20% total calorie intake from dietary fats
Bhuvana Sunil
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Dyslipidemia Measures
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Time frame: Baseline
Dyslipidemia Measures
Change in concentration of serum High density Lipoprotein in mg/dL
Time frame: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum Triglyceride level in mg/dL
Time frame: Baseline
Dyslipidemia Measures
Change in concentration of serum Triglyceride level in mg/dL
Time frame: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle number
Time frame: Baseline
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle number in percentage
Time frame: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle concentration
Time frame: Baseline
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle concentration in percentage
Time frame: Baseline to 8 weeks
Dyslipidemia Measures
Baseline total serum high density lipoprotein particle number
Time frame: Baseline
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Dyslipidemia Measures
percentage Change in concentration of serum high density lipoprotein particle
Time frame: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum small low-density lipoprotein particle concentration
Time frame: Baseline
Dyslipidemia Measures
Percentage change in concentration of serum small low density lipoprotein particle
Time frame: Baseline to 8 weeks
Dyslipidemia Measures
Baseline serum low-density lipoprotein size
Time frame: Baseline
Dyslipidemia Measures
Percentage change in concentration of serum small low-density lipoprotein size
Time frame: Baseline to 8 weeks
Insulin Resistance Indices
Percentage change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA\_IR is a scale where a higher number means worse outcome
Time frame: Baseline to 8 weeks
Insulin Resistance Indices
Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA\_IR is a scale where a higher number means worse outcome
Time frame: Baseline
Body Composition
Dual-energy X-ray absorptiometry (DXA) - measure of body fat
Time frame: Baseline
Body Composition
Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat
Time frame: Baseline to 8 weeks
Surrogate Markers of Vascular Endothelial Function
Baseline Pulse wave velocity
Time frame: Baseline
Surrogate Markers of Vascular Endothelial Function
Percentage Change in Pulse wave velocity
Time frame: Baseline to 8 weeks
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
The Augmentation Index a measure of peripheral arterial stiffness
Time frame: Baseline
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
The Augmentation Index a measure of peripheral arterial stiffness
Time frame: Baseline to 8 weeks