Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Overview

Randomized trial in a primary prevention population – all participants have high LDL cholesterol Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

Full Title of Study: “Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)

Detailed Description

This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statins(simvastatin) This alternative regimen is over the counter and available at health food stores. The alternative regimen consists of lifestyle changes including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling

Interventions

  • Drug: simvastatin
  • Drug: red yeast rice
  • Drug: pharmaceutical grade fish oil
  • Behavioral: therapeutic lifestyle changes

Clinical Trial Outcome Measures

Primary Measures

  • LDL-c cholesterol

Secondary Measures

  • total cholesterol
  • HDL
  • Triglycerides
  • cardiac CRP

Participating in This Clinical Trial

Inclusion Criteria

  • Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study Exclusion Criteria:

  • No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP>190 or DBP>100), cannot have known intolerance to one of the study drug

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chestnut Hill Health System
  • Overall Official(s)
    • David Becker, Principal Investigator,

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