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

Not Applicable

Completed

Interventions: Other: Standard low fat diet
Other: Carbohydrate restricted group

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Standard/Low fat diet group	Standard low fat diet	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.
Carbohydrate restricted group	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.

Primary Outcome Measures

Name	Time	Method
Dyslipidemia Measures	Baseline to 8 weeks	Percentage change in concentration of serum small low-density lipoprotein size
Insulin Resistance Indices	Baseline to 8 weeks	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

Name	Time	Method
Insulin Resistance Indices	Baseline	Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA_IR is a scale where a higher number means worse outcome
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	Baseline to 8 weeks	The Augmentation Index a measure of peripheral arterial stiffness
Surrogate Markers of Vascular Endothelial Function	Baseline to 8 weeks	Percentage Change in Pulse wave velocity
Body Composition	Baseline to 8 weeks	Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat

Locations (2): Bhuvana Sunil
🇺🇸
Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States