Novel Dietary Interventions for Treating Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in insulin resistance
研究概览
简要总结
Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI): 30.0-40.9 kg/m^2
- •Metabolic Syndrome
排除标准
- •Inflammatory diseases
- •Eating disorders
- •Pregnancy
- •Known kidney, coronary, gastrointestinal or peripheral artery disease
- •Recent fish oil (>500mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/day) or polyphenol supplement use
- •Recent weight change
- •Strenuous exercise
- •Fish/food allergies
- •Current diabetic, lipid-lowering (fibrates, statins), anti-inflammatory, immune-suppressant, and/or anti-inflammatory hypertension medication use
结局指标
主要结局
Change in insulin resistance
时间窗: Baseline, 6 weeks, and 12 weeks
Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
次要结局
- Change in inflammation biomarkers(Baseline, 6 weeks, 12 weeks)
研究者
Dorothy Sears
Associate Professor of Medicine
University of California, San Diego
