Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

Not Applicable

Completed

• Conditions: Atherosclerosis; Diabetes
• Interventions: Behavioral: Mindfulness-based stress reduction; Behavioral: Nutrition Enhancement

• Registration Number: NCT02165228
• Lead Sponsor: Montana State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-03
• Study Completion: 2012-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Study First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based stress reduction	Mindfulness-based stress reduction	Stress reduction class and behavioral intervention
Nutrition Enhancement	Nutrition Enhancement	Nutrition education class and behavioral intervention

Primary Outcome Measures

Name	Time	Method
Inflammation Biomarkers	16 weeks	C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6
Metabolic Syndrome Extent	16 weeks	Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components

Secondary Outcome Measures

Name	Time	Method
Waist to hip ratio	16 weeks	Circumference of the waist/circumference of the hips
Cholesterol	16 weeks	Fasting total cholesterol concentration
Insulin Resistance	16 weeks	Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)
Stress hormone levels	16 weeks	Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.
Perceived Stress	16 weeks	Score from the perceived stress scale.
Depression	16 weeks	Depression Score
BMI	16 weeks	BMI = weight/height squared
Mindfulness	16 weeks	Perception of mindfulness from subscale within the self-compassion scale questionnaire

Trial Locations

Locations (1)

Montana State University; 🇺🇸 Bozeman, Montana, United States