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临床试验/NCT02165228
NCT02165228已完成不适用

A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction

Montana State University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2010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
108
试验地点
2
主要终点
Inflammation Biomarkers

研究概览

简要总结

The long-term goal of the proposed research is to identify and develop effective interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a substantial contributor to inflammation, and interactions among stress, inflammation, body mass index, and health behaviors have been measured. Mindfulness-based stress reduction (MBSR) is effective for stress reduction, has been shown to be effective for inflammation reduction in individuals with disease, and is a sustainable practice for individuals across the health spectrum. Diet strategies are an effective means of reducing inflammation for some individuals, but may not be successful for many people, as evidenced by the steady rise in obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR compared to an established intervention of a nutrition enhancement (NE) intervention for the reduction of inflammation, and 2) test the effectiveness of MBSR compared to a non-intervention control conditions (CON) for the reduction of inflammation. Men and women 25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles, anthropometrics, dietary intake, and all components of the metabolic syndrome will be measured pre- and post-intervention to elucidate underlying mechanisms and to determine whether health benefits beyond inflammation reduction occur.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Elevated waist circumference or BMI

排除标准

  • Participation in calorie restricted diet in previous 30 d
  • Participation in stress reduction program in previous 30 d
  • Take blood pressure, lipid lowering or anti-inflammatory medications
  • Hypertension
  • Heart disease

结局指标

主要结局

Inflammation Biomarkers

时间窗: 16 weeks

C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6

Metabolic Syndrome Extent

时间窗: 16 weeks

Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components

次要结局

  • Perceived Stress(16 weeks)
  • Depression(16 weeks)
  • Waist to hip ratio(16 weeks)
  • Cholesterol(16 weeks)
  • Insulin Resistance(16 weeks)
  • Stress hormone levels(16 weeks)
  • BMI(16 weeks)
  • Mindfulness(16 weeks)

研究者

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

Mary Miles

Professor

Montana State University

研究点 (2)

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