Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
Completed · Not applicable
Conditions studied: Atherosclerosis, Diabetes
In brief
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.
Key facts
- Study ID
- NCT02165228
- Run by
- Montana State University
- People needed
- 108
- Starts
- 2010-01-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2014-06-17
Who can join
Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Elevated waist circumference or BMI
You may not qualify if…
- 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
- Diabetes
- Heart disease
Where it is running
- Montana State University — Bozeman, Montana, United States
Full record on ClinicalTrials.gov
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