Statins & nutraceuticals to prevent cardiovascular ageing

INTERVENTION: Double‐blind, randomized placebo‐controlled trial with 4 treatment arms, run in parallel. Participants are randomised to one treatment arm where they receive all treatments listed in that treatment arm. Arm 1: Atorvastatin 40mg, given as oral tablets once daily for 12 weeks + placebo given as oral tablets once daily for 12 weeks Arm 2: Nutraceutical combination containing 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice Extract (equivalent to 3 mg Monacolin K) + 2g Plant Sterols + 1.2 billion CFU ENLIVA (Lactobacillus plantarum) given as oral tablets once daily for 12 weeks + placebo given as oral tablets once daily for 12 weeks Arm 3: Atorvastatin 40mg, given as oral tablets once daily for 12 weeks + Nutraceutical combination containing 500mg Berberine (berberine hydrochloride) + 200mg Red Yeast Rice Extract (equivalent to 3 mg Monacolin K) + 2g Plant Sterols + 1.2 billion CFU ENLIVA (Lactobacillus plantarum) given as oral tablets once daily for 12 weeks Arm 4: Statin placebo given as oral tablets once daily for 12 weeks + nutraceutical placebos given as oral tablets once daily for 12 weeks. Compliance for all treatment arms will be monitored via tablet count from drug return. CONDITION: Cardiovascular disease PRIMARY OUTCOME: Low density lipoprotein (LDL) cholesterol levels as assessed via fasting blood sample, taken after a 12 hour fast. Vascular function as assessed via fasting ultrasound determination of flow‐mediated dilation of the brachial artery, after a 12 hour fast. SECONDARY OUTCOME: Gut microbiome composition as assessed via plasma and stool levels of short chain fatty acids and bile acids. INCLUSION CRITERIA: Participants aged 50‐70 years of age and who are at moderate risk of CVD will be recruited. Moderate risk will be defined as having one or more of the following: 1. Hypertension (mean clinic systolic > 135 mmHg, or diastolic > 85 mmHg, or treatment) 2. Dyslipidaemia (fasting total cholesterol > 5.5 mmol/L, or LDL > 2 mmol/L, or triglycerides > 1.5 mmol/L) 3. Central obesity (men > 100 cm and women > 89 cm) 4. Hyperglycaemia (fasting glucose > 5.5 mmol/L or treatment) 5. Overweight (BMI > 27) 6. A score of 10‐15% as calculated by the Australian Absolute Cardiovascular Disease Risk Score calculator