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OpenTrials
Completed

NCT Number: NCT02165228

Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

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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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montana State University

Bozeman, Montana, 59717, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Stress reduction class and behavioral intervention

Nutrition Enhancement

Behavioral

Nutrition education class and behavioral intervention

Primary outcomes

  1. Inflammation Biomarkers

    Time frame: 16 weeks

    C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6

  2. Metabolic Syndrome Extent

    Time frame: 16 weeks

    Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components

Secondary outcomes

  1. BMI

    Time frame: 16 weeks

    BMI = weight/height squared

  2. Waist to hip ratio

    Time frame: 16 weeks

    Circumference of the waist/circumference of the hips

  3. Cholesterol

    Time frame: 16 weeks

    Fasting total cholesterol concentration

  4. Insulin Resistance

    Time frame: 16 weeks

    Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)

  5. Stress hormone levels

    Time frame: 16 weeks

    Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.

  6. Perceived Stress

    Time frame: 16 weeks

    Score from the perceived stress scale.

  7. Depression

    Time frame: 16 weeks

    Depression Score

  8. Mindfulness

    Time frame: 16 weeks

    Perception of mindfulness from subscale within the self-compassion scale questionnaire

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: SICVDP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2014
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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