Clinical Trials Directory

Trials / Completed

CompletedNCT02165228

Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
Montana State University · Academic / Other
Sex
All
Age
25 Years – 55 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness-based stress reductionStress reduction class and behavioral intervention
BEHAVIORALNutrition EnhancementNutrition education class and behavioral intervention

Timeline

Start date
2010-01-01
Primary completion
2012-03-01
Completion
2012-12-01
First posted
2014-06-17
Last updated
2014-06-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02165228. Inclusion in this directory is not an endorsement.