NCT00365742

Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: Chestnut Hill Health System · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	simvastatin
DRUG	red yeast rice
DRUG	pharmaceutical grade fish oil
BEHAVIORAL	therapeutic lifestyle changes

Timeline

• Start date: 2006-04-01
• Completion: 2006-06-01
• First posted: 2006-08-17
• Last updated: 2006-08-17