Clinical trial NCT02165228: Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
Official title: A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Diabetes
Lead sponsor: Montana State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2014-06-17
Enrollment: 108
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Elevated waist circumference or BMI

Exclusion Criteria:

* 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

Primary outcomes:
measure: Inflammation Biomarkers
timeFrame: 16 weeks
measure: Metabolic Syndrome Extent
timeFrame: 16 weeks
Secondary outcomes:
measure: BMI
timeFrame: 16 weeks
measure: Waist to hip ratio
timeFrame: 16 weeks
measure: Cholesterol
timeFrame: 16 weeks
measure: Insulin Resistance
timeFrame: 16 weeks
measure: Stress hormone levels
timeFrame: 16 weeks
measure: Perceived Stress
timeFrame: 16 weeks
measure: Depression
timeFrame: 16 weeks
measure: Mindfulness
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
affiliation: Montana State University
name: Mary P Miles, PhD
role: PRINCIPAL_INVESTIGATOR
References: