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

Overview

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.

Full Title of Study: “Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2021

Detailed Description

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.

Interventions

  • Other: Carbohydrate restricted group
    • Prescribed low carbohydrate diet with set recipes
  • Other: Standard low fat diet
    • Diet with less than 20% total calorie intake from dietary fats

Arms, Groups and Cohorts

  • Active Comparator: Carbohydrate restricted group
    • 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.
  • Active Comparator: Standard/Low fat diet group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline concentration of serum High-density Lipoprotein level in mg/dL
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • Change in concentration of serum High density Lipoprotein in mg/dL
  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline concentration of serum Triglyceride level in mg/dL
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • Change in concentration of serum Triglyceride level in mg/dL
  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline concentration of serum lipoprotein particle number
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • Change in concentration of serum lipoprotein particle number in percentage
  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline concentration of serum lipoprotein particle concentration
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • Change in concentration of serum lipoprotein particle concentration in percentage
  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline total serum high density lipoprotein particle number
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • percentage Change in concentration of serum high density lipoprotein particle
  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline concentration of serum small low-density lipoprotein particle concentration
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • Percentage change in concentration of serum small low density lipoprotein particle
  • Dyslipidemia Measures
    • Time Frame: Baseline
    • Baseline serum low-density lipoprotein size
  • Dyslipidemia Measures
    • Time Frame: Baseline to 8 weeks
    • Percentage change in concentration of serum small low-density lipoprotein size
  • Insulin Resistance Indices
    • Time Frame: Baseline to 8 weeks
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bhuvana Sunil, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Bhuvana Sunil, MD, Principal Investigator, University of Alabama at Birmingham

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