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临床试验/NCT02006394
NCT02006394已完成不适用

Novel Dietary Interventions for Treating Insulin Resistance

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorothy Sears

Associate Professor of Medicine

University of California, San Diego

研究点 (2)

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