None listed
Conditions
Brief summary
This project will investigate the role of natural plant and food-derived compounds (nutraceuticals) and their ability to lower cholesterol levels in high-risk patients who are unable to take standard statin therapy due to side effects. It is expected that a combination of natural compounds with known cholesterol lowering ability will reduce cholesterol levels in this high-risk population. When taken in conjunction with non-statin pharmacotherapy, these natural compounds will offer additional benefits, including additive reduction in cholesterol levels. In addition to helping these patients achieve cholesterol targets, these natural compounds will prevent the development of side effects associated with statin use, leading to greater adherence to their medication regime and an overall reduction in the risk of heart disease. Given the prevelance of heart disease within the Australian population and the need to identify alternative treatment options to lower cholesterol, the findings of this study will have enormous significance and translation potential for clinical practice.
Interventions
Randomsied, double-blind, placebo controlled trial. Three interventional arms and 1 placebo/comparator arm. Participants are randomised to one treatment arm only and study is parallel in design.
Arm 1: Ezetrol 10mg taken once daily for 8 weeks via oral tablet + Nutraceutical Placebo once daily for 8 weeks via oral tablets.
Arm 2: Nutraceutical containing: 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice (equivalent to 3mg Monacolin K) + 2g Plant Sterols taken once daily for 8 wee
Randomsied, double-blind, placebo controlled trial. Three interventional arms and 1 placebo/comparator arm. Participants are randomised to one treatment arm only and study is parallel in design. Arm 1: Ezetrol 10mg taken once daily for 8 weeks via oral tablet + Nutraceutical Placebo once daily for 8 weeks via oral tablets. Arm 2: Nutraceutical containing: 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice (equivalent to 3mg Monacolin K) + 2g Plant Sterols taken once daily for 8 weeks via oral tablets + Ezetrol Placebo taken once daily for 8 weeks via oral tablet Arm 3: Ezetrol 10mg taken once daily for 8 weeks via oral tablet + Nutraceutical containing: 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice (equivalent to 3mg Monacolin K) + 2g Plant Sterols taken once daily for 8 weeks via oral tablets Arm 4: Ezetrol Placebo taken once daily for 8 weeks via oral tablet + Nutraceutical Placebo taken once daily for 8 weeks via oral tablets For additional notes on placebo tablets, please see section below. Compliance will be monitored via drug tablet return.
Sponsors
Curtin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients who are intolerant to statins and not currently achieving lipid targets (fasting LDL-c >1.8 mmol/L and <7 mmol/L). Statin intolerance will be defined as an inability to tolerate 2 or more statins, one at a low dose, due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued. Low dose statin therapy is defined as an average daily dose of rosuvastatin 5mg, atorvastatin 10mg, simvastatin 10mg, lovastatin 20mg, pravastatin 40mg, fluvastatin 40mg or pitavastatin 2mg. Patients tolerating very low dose statin therapy (rosuvastatin <5mg, atorvastatin <10mg, simvastatin <10mg, lovastatin <20mg, pravastatin <40mg, fluvastatin <40mg or pitavastatin <2mg) are considered to be intolerant to that low dose statin.
Exclusion criteria
- Participants with pre-existing coronary artery disease (calcium score >0, previous coronary event) who are currently taking Ezetimibe or other cholesterol-lowering medication - No documented statin intolerance - Abnormal biochemistry at screening suggestive of an additional underlying cause of statin intolerance - Pregnant or lactating women - Inability to provide informed written consent.
Outcome results
None listed