Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical

Study Overview
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Brief Summary
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The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical.

Detailed Description
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The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical significantly increases the LDL-C lowering effect of guideline-driven lifestyle interventions in subjects with hypercholesterolemia at low-moderate cardiovascular risk not requiring a drug therapy.

Official Title
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Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical , in Subjects With Hypercholesterolemia at Low-moderate Cardiovascular Risk Not Requiring a Drug Therapy

Conditions
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Hypercholesterolemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 25 and 75 years; In primary prevention for low-moderate CV risk, with diet and physical exercise to control raised LDL-C level, for at least 3 months; LDL-C > 100 mg/dL (2.6 mmol/L), < 190 mg/dL (4.9 mmol/L) CV risk SCORE <5% (based on SCORE chart according to figure I for Poland respective figure 2 for Austria and Germany in the ESC/EAS guideline 2019); Triglyceride <400 mg/dL; Advised to use nutraceutical as part of the lifestyle intervention as per guideline and within the product label (i.e. posology as in product label); Written informed consent. Exclusion Criteria: Subjects being treated or who have been treated for up to 3 months before the start of the study with lipid-lowering drugs or nutraceuticals including functional foods for which lipid-lowering effects are known (e.g. fish oil, sterol-containing yoghurts etc.); Subjects involved in other clinical studies with pharmaceutical products Known laboratory evidence of either liver, muscle, thyroid or kidney dysfunction; Subjects with prior history of cardiovascular events or with high cardiovascular risk equivalents; Uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg); Pregnancy and breastfeeding.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Armolipid-L/Armolipid Plus-L<br>Armolipid-L used for participants in Germany and Poland Armolipid Plus-L used for participants in Austria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in LDL-C | Mean change from baseline in LDL-C at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS) | Subjects' adherence (at 3 months and 6 months) to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS); minimum 0mm, maximum 100mm; higher value means better adherence | at 3 months and 6 months |