None listed
Conditions
Brief summary
Cardiovascular disease (CVD) is the leading cause of death and disability. Ageing is associated with a number of traditional CVD risk factors, including high blood pressure and high cholesterol, as well as changes to the structure of our heart and blood vessels, which over time contribute to an increased risk of cardiovascular events. Statins are common cholesterol-lowering drugs that have been shown to reduce the risk of developing heart disease. Nutraceuticals are food components or active ingredients in food that may be used as therapeutic agents to help lower cholesterol and modify risk of heart disease. This project will investigate the effect of statins and nutraceuticals, either alone or in combination, on markers of heart and blood vessel function in people at moderate risk of heart disease. We hypothesise that statin therapy will delay the cardiovascular ageing process, as evidenced by improvements in structural and functional outcomes. These improvements will be further enhanced with adjunct nutraceutical therapy. In addition to the beneficial effects on risk factors for heart disease, nutraceutical compounds will offer additional benefit through changes to the gut microbiome, including improvements in bacterial diversity and composition, as well as alterations in the production of important short chain fatty acids and bile acids.
Interventions
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
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.
Sponsors
Curtin University
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
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
Exclusion criteria
• Previous known statin intolerance • Current use of statin therapy • Pregnant or lactating women • BMI >35 kg/m2 • Any adult with a previous diagnosis of a severe co-existing medical condition that would prevent participation (e.g. severe dementia or terminal illness) • Alcohol intake >3 standard drinks a day (men) or >2 standard drinks a day (women) • Vegetarian, vegan or previous gastric banding surgery • Current use of prebiotic or probiotic medications • Recent use of antibiotics (<3 months) • Current smoker or quit smoking within the last 3 months • Unable to give informed consent
Outcome results
None listed