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

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ClinicalTrials.gov Identifier: NCT03937960
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bhuvana Sunil, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Dyslipidemias Other: Carbohydrate restricted group Other: Standard low fat diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum High density Lipoprotein level in mg/dL

  2. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum High density Lipoprotein in mg/dL

  3. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum Triglyceride level in mg/dL

  4. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum Triglyceride level in mg/dL

  5. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum lipoprotein particle number

  6. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum lipoprotein particle number

  7. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum lipoprotein particle concentration

  8. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum lipoprotein particle concentration

  9. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum high density lipoprotein particle

  10. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum high density lipoprotein particle

  11. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum small low density lipoprotein particle

  12. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum small low density lipoprotein particle

  13. Dyslipidemia measures [ Time Frame: Baseline ]
    Change in concentration of serum small low density lipoprotein size

  14. Dyslipidemia measures [ Time Frame: Baseline to 8 weeks ]
    Change in concentration of serum small low density lipoprotein size


Secondary Outcome Measures :
  1. Insulin resistance indices [ Time Frame: Baseline ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  2. Insulin resistance indices [ Time Frame: Baseline to 8 weeks ]
    Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  3. Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition

  4. Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) total body composition

  5. Body composition [ Time Frame: Baseline ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content

  6. Body composition [ Time Frame: Baseline to 8 weeks ]
    Change in Dual-energy X-ray absorptiometry (DXA) body fat content

  7. Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in flow mediated dilation

  8. Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in flow mediated dilation

  9. Surrogate markers of vascular endothelial function [ Time Frame: Baseline ]
    Change in Pulse wave velocity

  10. Surrogate markers of vascular endothelial function [ Time Frame: Baseline to 8 weeks ]
    Change in Pulse wave velocity

  11. Surrogate markers of vascular endothelial function as measured by Augmentation index [ Time Frame: Baseline ]
    The Augmentation Index a measure of peripheral arterial stiffness

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937960


Contacts
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Contact: BHUVANA SUNIL, MD 2056386456 bsunil@uabmc.edu

Locations
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United States, Alabama
Bhuvana Sunil Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Bhuvana Sunil    205-638-6456    bsunil@uabmc.edu   
Principal Investigator: BHUVANA Sunil, MD         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: BHUVANA SUNIL, MD    205-638-9107    bsunil@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Bhuvana Sunil, MD University of Alabama at Birmingham
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Responsible Party: Bhuvana Sunil, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03937960    
Other Study ID Numbers: IRB-300002816
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bhuvana Sunil, University of Alabama at Birmingham:
Dietary intervention
Anthropometric measure
Lipid profile
Augmentation Index
Flow mediated dilation
DXA scan
Nuclear magnetic resonance lipid profile
Additional relevant MeSH terms:
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Metabolic Syndrome
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders