Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Dyslipidemia Measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Carbohydrate restricted group (Other)
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.
干预措施: Standard low fat diet (Other)
结局指标
主要结局
Dyslipidemia Measures
时间窗: Baseline to 8 weeks
Change in concentration of serum High density Lipoprotein in mg/dL
Insulin Resistance Indices
时间窗: 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
Dyslipidemia Measures
时间窗: Baseline
Baseline concentration of serum High-density Lipoprotein level in mg/dL
次要结局
- Insulin Resistance Indices(Baseline)
- Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index(Baseline to 8 weeks)
- Surrogate Markers of Vascular Endothelial Function(Baseline to 8 weeks)
- Body Composition(Baseline to 8 weeks)
- Body Composition(Baseline)
- Surrogate Markers of Vascular Endothelial Function(Baseline)
- Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index(Baseline)
研究者
Bhuvana Sunil
Principal Investigator
University of Alabama at Birmingham