Montana State University
Bozeman, Montana, 59717, United States
NCT Number: NCT02165228
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.
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Notify Me25 year–55 year
All sexes
Interventional
Not applicable
Bozeman, Montana, 59717, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stress reduction class and behavioral intervention
Nutrition education class and behavioral intervention
Time frame: 16 weeks
C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6
Time frame: 16 weeks
Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components
Time frame: 16 weeks
BMI = weight/height squared
Time frame: 16 weeks
Circumference of the waist/circumference of the hips
Time frame: 16 weeks
Fasting total cholesterol concentration
Time frame: 16 weeks
Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 16 weeks
Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.
Time frame: 16 weeks
Score from the perceived stress scale.
Time frame: 16 weeks
Depression Score
Time frame: 16 weeks
Perception of mindfulness from subscale within the self-compassion scale questionnaire
Montana State University
Other
A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction
Acronym: SICVDP
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