Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Obesity, Dyslipidemias

Intervention / Treatment
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* Other: Carbohydrate restricted group
* Other: Standard low fat diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 out of 5 of the following criteria Metabolic syndrome with dyslipidemia (HDL <40mg/dL Triglyceride (TG) TG>150mg/dL) Glucose intolerance (fasting blood sugar >100mg/dL) Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower) Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension Exclusion Criteria: Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants) Pregnancy Untreated thyroid disease, heart disease, cancer, kidney disease Children on statin/fibrate treatments or other lipid-lowering medications Prior surgical procedure for weight control or current weight loss medication

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbohydrate restricted group<br>This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries. | Other: Carbohydrate restricted group<br>* Prescribed low carbohydrate diet with set recipes<br>|
| Active Comparator: Standard/Low fat diet group<br>The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats. | Other: Standard low fat diet<br>* Diet with less than 20% total calorie intake from dietary fats<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyslipidemia Measures | Baseline concentration of serum High-density Lipoprotein level in mg/dL | Baseline | 
| Dyslipidemia Measures | Change in concentration of serum High density Lipoprotein in mg/dL | Baseline to 8 weeks | 
| Dyslipidemia Measures | Baseline concentration of serum Triglyceride level in mg/dL | Baseline | 
| Dyslipidemia Measures | Change in concentration of serum Triglyceride level in mg/dL | Baseline to 8 weeks | 
| Dyslipidemia Measures | Baseline concentration of serum lipoprotein particle number | Baseline | 
| Dyslipidemia Measures | Change in concentration of serum lipoprotein particle number in percentage | Baseline to 8 weeks | 
| Dyslipidemia Measures | Baseline concentration of serum lipoprotein particle concentration | Baseline | 
| Dyslipidemia Measures | Change in concentration of serum lipoprotein particle concentration in percentage | Baseline to 8 weeks | 
| Dyslipidemia Measures | Baseline total serum high density lipoprotein particle number | Baseline | 
| Dyslipidemia Measures | percentage Change in concentration of serum high density lipoprotein particle | Baseline to 8 weeks | 
| Dyslipidemia Measures | Baseline concentration of serum small low-density lipoprotein particle concentration | Baseline | 
| Dyslipidemia Measures | Percentage change in concentration of serum small low density lipoprotein particle | Baseline to 8 weeks | 
| Dyslipidemia Measures | Baseline serum low-density lipoprotein size | Baseline | 
| Dyslipidemia Measures | Percentage change in concentration of serum small low-density lipoprotein size | 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 | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance Indices | Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA_IR is a scale where a higher number means worse outcome | Baseline | 
| Body Composition | Dual-energy X-ray absorptiometry (DXA) - measure of body fat | Baseline | 
| Body Composition | Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat | Baseline to 8 weeks | 
| Surrogate Markers of Vascular Endothelial Function | Baseline Pulse wave velocity | Baseline | 
| Surrogate Markers of Vascular Endothelial Function | Percentage Change in Pulse wave velocity | Baseline to 8 weeks | 
| Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | The Augmentation Index a measure of peripheral arterial stiffness | Baseline | 
| Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | The Augmentation Index a measure of peripheral arterial stiffness | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DXA scan, Dietary intervention, Anthropometric measure, Lipid profile, Augmentation Index, Flow mediated dilation, Nuclear magnetic resonance lipid profile