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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT03937960

Collaborator

(none)

Enrollment

Locations

Arms

13.9

Actual Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Metabolic Syndrome Obesity Dyslipidemias	Other: Carbohydrate restricted group Other: Standard low fat diet	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

Actual 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 :

Jan 1, 2020

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 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

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

Dyslipidemia measures [Baseline]
Change in concentration of serum High density Lipoprotein level in mg/dL
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum High density Lipoprotein in mg/dL
Dyslipidemia measures [Baseline]
Change in concentration of serum Triglyceride level in mg/dL
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum Triglyceride level in mg/dL
Dyslipidemia measures [Baseline]
Change in concentration of serum lipoprotein particle number
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum lipoprotein particle number
Dyslipidemia measures [Baseline]
Change in concentration of serum lipoprotein particle concentration
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum lipoprotein particle concentration
Dyslipidemia measures [Baseline]
Change in concentration of serum high density lipoprotein particle
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum high density lipoprotein particle
Dyslipidemia measures [Baseline]
Change in concentration of serum small low density lipoprotein particle
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum small low density lipoprotein particle
Dyslipidemia measures [Baseline]
Change in concentration of serum small low density lipoprotein size
Dyslipidemia measures [Baseline to 8 weeks]
Change in concentration of serum small low density lipoprotein size

Secondary Outcome Measures

Insulin resistance indices [Baseline]
Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance indices [Baseline to 8 weeks]
Change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Body composition [Baseline]
Change in Dual-energy X-ray absorptiometry (DXA) total body composition
Body composition [Baseline to 8 weeks]
Change in Dual-energy X-ray absorptiometry (DXA) total body composition
Body composition [Baseline]
Change in Dual-energy X-ray absorptiometry (DXA) body fat content
Body composition [Baseline to 8 weeks]
Change in Dual-energy X-ray absorptiometry (DXA) body fat content
Surrogate markers of vascular endothelial function [Baseline]
Change in flow mediated dilation
Surrogate markers of vascular endothelial function [Baseline to 8 weeks]
Change in flow mediated dilation
Surrogate markers of vascular endothelial function [Baseline]
Change in Pulse wave velocity
Surrogate markers of vascular endothelial function [Baseline to 8 weeks]
Change in Pulse wave velocity
Surrogate markers of vascular endothelial function as measured by Augmentation index [Baseline]
The Augmentation Index a measure of peripheral arterial stiffness
Surrogate markers of vascular endothelial function as measured by Augmentation index [Baseline to 8 weeks]
The Augmentation Index a measure of peripheral arterial stiffness

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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