Dose response study of phytosterols in tablet dosage in adults with primary hypercholeterolemia
Phase 2
Completed
- Conditions
- Primary hypercholesterolemiaDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12605000303640
- Lead Sponsor
- Mayne Health Consumer Products
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1) LDL cholesterol greater then or equal to 3.5mmol/L and less than or equal to 5.7 mmol/L 2) Body mass index less than or equal to 32kg/m2
Exclusion Criteria
1) Triglyceride levels greater then 4mmol/L2) Total cholesterol greater than 10mmol/L3) Use of lipid lowering medications including herbal and other natural lipid lowering agents with one month of baseline4) Clinically abnormal liver function tests at baseline5) Pregnant or women unwilling to use birth control for the period of the study6) Diabetes7) Hypothyroidism8) Smokers9) Cardiovascular disease10) Subjects unwilling to comply with study protocol11) Poor venous access12) Any other condition which in the opinion of the investigators could compromise the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in LDL cholesterol from baseline to end of treatment.[At baseline and at end of treatment]
- Secondary Outcome Measures
Name Time Method Changes in total cholesterol[Following 12 weeks of treatment.];Changes in high density lipoprotein cholesterol and triglycerides[Following 12 weeks of treatment.]