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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03937960

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted July 30, 2020

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.

  • Condition or Disease:Metabolic Syndrome
    Obesity
    Dyslipidemias
  • Intervention/Treatment: Other: Carbohydrate restricted group
    Other: Standard low fat diet
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2020
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 10 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 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

Contacts and Locations
Contacts

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

Locations

United States, Alabama
Bhuvana Sunil
Birmingham

United States, Alabama
University of Alabama at Birmingham
Birmingham

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Bhuvana Sunil, MD University of Alabama at Birmingham

More Information
  • Responsible Party: University of Alabama at Birmingham
  • ClinicalTrials.gov Identifier: NCT03937960 History of Changes
  • Other Study ID Numbers: IRB-300002816
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: July 30, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Alabama at Birmingham: Anthropometric measure
    Lipid profile
    Augmentation Index
    Flow mediated dilation
    DXA scan
    Dietary intervention
    Nuclear magnetic resonance lipid profile
  • Additional relevant MeSH terms: Syndrome
    Metabolic Syndrome
    Dyslipidemias