search
Back to results

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

Primary Purpose

Metabolic Syndrome, Obesity, Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbohydrate restricted group
Standard low fat diet
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Dietary intervention, Anthropometric measure, Lipid profile, Augmentation Index, Flow mediated dilation, DXA scan, Nuclear magnetic resonance lipid profile

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bhuvana Sunil
  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carbohydrate restricted group

Standard/Low fat diet group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dyslipidemia Measures
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Dyslipidemia Measures
Change in concentration of serum High density Lipoprotein in mg/dL
Dyslipidemia Measures
Baseline concentration of serum Triglyceride level in mg/dL
Dyslipidemia Measures
Change in concentration of serum Triglyceride level in mg/dL
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle number
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle number in percentage
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle concentration
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle concentration in percentage
Dyslipidemia Measures
Baseline total serum high density lipoprotein particle number
Dyslipidemia Measures
percentage Change in concentration of serum high density lipoprotein particle
Dyslipidemia Measures
Baseline concentration of serum small low-density lipoprotein particle concentration
Dyslipidemia Measures
Percentage change in concentration of serum small low density lipoprotein particle
Dyslipidemia Measures
Baseline serum low-density lipoprotein size
Dyslipidemia Measures
Percentage change in concentration of serum small low-density lipoprotein size
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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2019
Last Updated
November 29, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT03937960
Brief Title
Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Official Title
Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Dyslipidemias
Keywords
Dietary intervention, Anthropometric measure, Lipid profile, Augmentation Index, Flow mediated dilation, DXA scan, Nuclear magnetic resonance lipid profile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate restricted group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard/Low fat diet group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Carbohydrate restricted group
Intervention Description
Prescribed low carbohydrate diet with set recipes
Intervention Type
Other
Intervention Name(s)
Standard low fat diet
Intervention Description
Diet with less than 20% total calorie intake from dietary fats
Primary Outcome Measure Information:
Title
Dyslipidemia Measures
Description
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
Change in concentration of serum High density Lipoprotein in mg/dL
Time Frame
Baseline to 8 weeks
Title
Dyslipidemia Measures
Description
Baseline concentration of serum Triglyceride level in mg/dL
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
Change in concentration of serum Triglyceride level in mg/dL
Time Frame
Baseline to 8 weeks
Title
Dyslipidemia Measures
Description
Baseline concentration of serum lipoprotein particle number
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
Change in concentration of serum lipoprotein particle number in percentage
Time Frame
Baseline to 8 weeks
Title
Dyslipidemia Measures
Description
Baseline concentration of serum lipoprotein particle concentration
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
Change in concentration of serum lipoprotein particle concentration in percentage
Time Frame
Baseline to 8 weeks
Title
Dyslipidemia Measures
Description
Baseline total serum high density lipoprotein particle number
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
percentage Change in concentration of serum high density lipoprotein particle
Time Frame
Baseline to 8 weeks
Title
Dyslipidemia Measures
Description
Baseline concentration of serum small low-density lipoprotein particle concentration
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
Percentage change in concentration of serum small low density lipoprotein particle
Time Frame
Baseline to 8 weeks
Title
Dyslipidemia Measures
Description
Baseline serum low-density lipoprotein size
Time Frame
Baseline
Title
Dyslipidemia Measures
Description
Percentage change in concentration of serum small low-density lipoprotein size
Time Frame
Baseline to 8 weeks
Title
Insulin Resistance Indices
Description
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
Secondary Outcome Measure Information:
Title
Insulin Resistance Indices
Description
Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA_IR is a scale where a higher number means worse outcome
Time Frame
Baseline
Title
Body Composition
Description
Dual-energy X-ray absorptiometry (DXA) - measure of body fat
Time Frame
Baseline
Title
Body Composition
Description
Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat
Time Frame
Baseline to 8 weeks
Title
Surrogate Markers of Vascular Endothelial Function
Description
Baseline Pulse wave velocity
Time Frame
Baseline
Title
Surrogate Markers of Vascular Endothelial Function
Description
Percentage Change in Pulse wave velocity
Time Frame
Baseline to 8 weeks
Title
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
Description
The Augmentation Index a measure of peripheral arterial stiffness
Time Frame
Baseline
Title
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
Description
The Augmentation Index a measure of peripheral arterial stiffness
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhuvana Sunil, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bhuvana Sunil
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs