A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction
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
- 是
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
Mary Miles
Professor
Montana State University
