Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

Diabetes Clinical Trial

— SICVDP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165228
• Other study ID #: 10GRNT260013
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: June 13, 2014
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Diabetes

Intervention

Behavioral:
• Mindfulness-based stress reduction
Stress reduction class and behavioral intervention
• Nutrition Enhancement
Nutrition education class and behavioral intervention

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Montana State University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation Biomarkers	C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6	16 weeks	No
Primary	Metabolic Syndrome Extent	Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components	16 weeks	No
Secondary	BMI	BMI = weight/height squared	16 weeks	No
Secondary	Waist to hip ratio	Circumference of the waist/circumference of the hips	16 weeks	No
Secondary	Cholesterol	Fasting total cholesterol concentration	16 weeks	No
Secondary	Insulin Resistance	Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)	16 weeks	No
Secondary	Stress hormone levels	Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.	16 weeks	No
Secondary	Perceived Stress	Score from the perceived stress scale.	16 weeks	No
Secondary	Depression	Depression Score	16 weeks	No
Secondary	Mindfulness	Perception of mindfulness from subscale within the self-compassion scale questionnaire	16 weeks	No