Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Chestnut Hill Health System

Status

Completed

Conditions

Hyperlipidemia

Treatments

Behavioral: therapeutic lifestyle changes

Drug: pharmaceutical grade fish oil

Drug: simvastatin

Drug: red yeast rice

Study type

Interventional

Funder types

Other

Identifiers

NCT00365742

FWA00005390-Chestnut Hill Hosp

Details and patient eligibility

About

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 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

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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