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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937960
• Other study ID #: IRB-300002816
• Secondary ID: P30DK056336
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: November 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Bhuvana Sunil	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyslipidemia Measures	Baseline concentration of serum High-density Lipoprotein level in mg/dL	Baseline
Primary	Dyslipidemia Measures	Change in concentration of serum High density Lipoprotein in mg/dL	Baseline to 8 weeks
Primary	Dyslipidemia Measures	Baseline concentration of serum Triglyceride level in mg/dL	Baseline
Primary	Dyslipidemia Measures	Change in concentration of serum Triglyceride level in mg/dL	Baseline to 8 weeks
Primary	Dyslipidemia Measures	Baseline concentration of serum lipoprotein particle number	Baseline
Primary	Dyslipidemia Measures	Change in concentration of serum lipoprotein particle number in percentage	Baseline to 8 weeks
Primary	Dyslipidemia Measures	Baseline concentration of serum lipoprotein particle concentration	Baseline
Primary	Dyslipidemia Measures	Change in concentration of serum lipoprotein particle concentration in percentage	Baseline to 8 weeks
Primary	Dyslipidemia Measures	Baseline total serum high density lipoprotein particle number	Baseline
Primary	Dyslipidemia Measures	percentage Change in concentration of serum high density lipoprotein particle	Baseline to 8 weeks
Primary	Dyslipidemia Measures	Baseline concentration of serum small low-density lipoprotein particle concentration	Baseline
Primary	Dyslipidemia Measures	Percentage change in concentration of serum small low density lipoprotein particle	Baseline to 8 weeks
Primary	Dyslipidemia Measures	Baseline serum low-density lipoprotein size	Baseline
Primary	Dyslipidemia Measures	Percentage change in concentration of serum small low-density lipoprotein size	Baseline to 8 weeks
Primary	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	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
Secondary	Body Composition	Dual-energy X-ray absorptiometry (DXA) - measure of body fat	Baseline
Secondary	Body Composition	Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat	Baseline to 8 weeks
Secondary	Surrogate Markers of Vascular Endothelial Function	Baseline Pulse wave velocity	Baseline
Secondary	Surrogate Markers of Vascular Endothelial Function	Percentage Change in Pulse wave velocity	Baseline to 8 weeks
Secondary	Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	The Augmentation Index a measure of peripheral arterial stiffness	Baseline
Secondary	Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	The Augmentation Index a measure of peripheral arterial stiffness	Baseline to 8 weeks