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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Dyslipidemias
• Intervention / Treatment: Other: Carbohydrate restricted group; Other: Standard low fat diet

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35233
      • Bhuvana Sunil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Carbohydrate restricted group; Prescribed low carbohydrate diet with set recipes
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.	Other: Standard low fat diet; Diet with less than 20% total calorie intake from dietary fats

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Bhuvana Sunil, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Augmentation Index; Lipid profile; Dietary intervention; Flow mediated dilation; Anthropometric measure; DXA scan; Nuclear magnetic resonance lipid profile
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Syndrome; Metabolic Syndrome; Dyslipidemias
• Other Study ID Numbers: IRB-300002816; P30DK056336 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No