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

NCT ID: NCT03937960

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-02-28

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.

Conditions

Metabolic Syndrome; Obesity; Dyslipidemias

Keywords

Dietary intervention; Anthropometric measure; Lipid profile; Augmentation Index; Flow mediated dilation; DXA scan; Nuclear magnetic resonance lipid profile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Carbohydrate restricted group

Intervention Type: OTHER

Prescribed low carbohydrate diet with set recipes

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.

Group Type: ACTIVE_COMPARATOR

Standard low fat diet

Intervention Type: OTHER

Diet with less than 20% total calorie intake from dietary fats

Interventions

Carbohydrate restricted group

Prescribed low carbohydrate diet with set recipes

Intervention Type: OTHER

Standard low fat diet

Diet with less than 20% total calorie intake from dietary fats

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Bhuvana Sunil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bhuvana Sunil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Bhuvana Sunil

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30DK056336

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300002816

Identifier Type: -

Identifier Source: org_study_id