Hyperlipidemia
Conditions
Keywords
red yeast rice, pharmaceutical grade fish oil, simvastatin, primary prevention
Brief 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
Interventions
DRUGsimvastatin
DRUGred yeast rice
DRUGpharmaceutical grade fish oil
BEHAVIORALtherapeutic lifestyle changes
Sponsors
Chestnut Hill Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-c cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| total cholesterol | — |
| HDL | — |
| Triglycerides | — |
| cardiac CRP | — |
Outcome results
None listed