None listed
Conditions
Brief summary
The combination of nutraceuticals based on monacolin allows achieving LDL-C reductions by using lower doses of each component, and thus reduces the likelihood of adverse events re-lated to a single component. Nonetheless, because these supplements contain additional cholesterol-lowering agents, it is challenging to discern whether the lipid-lowering effect was primarily due to monacolin K or another agent.various studies assessing the effects of RYR food supplements containing monacolins yielded safety concerns when the dose of monacolin reached 10 mg/day. The aim of this study is to assess the lipid-lowering activity and safety of a novel, commercially available dietary supplement, containing low dose of monacolin (<3mg) combined with other plant derived ingredients in subjects with moderate elevations in LDL-C concentrations and low cardiovascular risk.
Interventions
Randomsied, placebo controlled trial. One interventional arm and one placebo/comparator arm. Participants are randomised to treatment arm or placebo.The study is parallel in design.
Arm 1: Nutraceutical containing: Red Yeast Rice (equivalent to 2.8mg Monacolin K) + Bergamot dry extract 250mg+ 2g Plant Policozanol 24mg + thiest dry extract 16mg + coenzyme Q10 ,taken once daily for 8 weeks via oral tablets plus Mediterranean Diet Meal Plan
Arm 2: Nutraceutical Placebo once daily for 8 weeks via
Randomsied, placebo controlled trial. One interventional arm and one placebo/comparator arm. Participants are randomised to treatment arm or placebo.The study is parallel in design. Arm 1: Nutraceutical containing: Red Yeast Rice (equivalent to 2.8mg Monacolin K) + Bergamot dry extract 250mg+ 2g Plant Policozanol 24mg + thiest dry extract 16mg + coenzyme Q10 ,taken once daily for 8 weeks via oral tablets plus Mediterranean Diet Meal Plan Arm 2: Nutraceutical Placebo once daily for 8 weeks via oral tablets and Mediterranean Diet Meal Plan Compliance will be monitored via drug tablet return For additional notes on placebo tablets, please see section below.
Sponsors
Nicholaos Angelopoulos,MD,Phd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients are eligible to participate in the present study if they have mild hypercholesterolemia (fasting LDL-C concentration between 140 and 180 mg/dL) and no indication for statin treatment [10-year atherosclerotic cardiovascular disease risk (ASCVD Risk) < 7.5%]. The 10-year risk wil be calculated in all participants using the updated ASCVD Risk Estimator Plus (found in: https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate
Exclusion criteria
Use of lipid-lowering medications, such as statins, within 3 months prior to study enrollment, conditions which produce an increased ASCVD risk, such as diabetes mellitus, known atherosclerotic vascular disease, or moderate/severe renal insufficiency (Modification of Diet in Renal Disease calculated glomerular filtration rate, MDRD GFR < 60 mL/min), abnormal liver function tests, excessive alcohol intake, pregnancy, lactation or the use of oral contraceptives
Outcome results
None listed