Hypercholesteremia Nutritional, Metabolic, Endocrine Hypercholesterolemia
Conditions
Interventions
Red Yeast Rice Stage One: This stage is a randomised, double blind, placebo-controlled, three arm parallel study. The study will compare baseline lipid levels with post-treatment levels for the treatm
Sponsors
Sylvan Health Pty Ltd (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. LDL cholesterol more than or equal to 3.5 to less than or equal to 5.7 mmol/l 2. Aged 18 to 75 years 3. Body mass index less than or equal to 32 kg/m^2
Exclusion criteria
Exclusion criteria: 1. Triglyceride levels more than 4 mmol/l 2. Total cholesterol more than 10 mmol/l 3. Use of lipid lowering medications including herbal and other "natural" lipid lowering agents within one month of baseline 4. Liver function enzymes more than three times the upper limit of normal at baseline 5. Pregnant women or women unwilling to use birth control for the duration of the study 6. Diabetes 7. Hypothyroidism 8. Smoking 9. Cardiovascular disease 10. Subjects unwilling to comply with study protocol 11. Poor venous access 12. Any other condition, which in the opinion of the investigators could compromise the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL cholesterol from baseline to end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total cholesterol, High-Density Lipoprotein cholesterol (HDL) and triglycerides. | — |
Countries
Australia
Outcome results
None listed