Trial | NCT00365742  Report issue

Title

Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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
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
Study Started
Apr 30
2006
Study Completion
Jun 30
2006
Last Update
Aug 17
2006
Estimate

Drug simvastatin

Drug red yeast rice

Drug pharmaceutical grade fish oil

Behavioral therapeutic lifestyle changes

Criteria 

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
No Results Posted