Clinical trial NCT05000541: Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan Österreich GmbH
name: Mylan Germany GmbH
name: Mylan Healthcare Sp. z o.o.
First posted: 2021-08-11
Enrollment: 259
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects to be enrolled are subjects already in primary prevention for CVD for raised LDL-C and who, according to the intervention strategies recommended in Table 5 of the ESC/EAS guidelines (lifestyle interventions, consider drug if uncontrolled) had been prescribed, in the previous 3 months, only dietary advices and physical exercise.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in LDL-C
timeFrame: 3 months
Secondary outcomes:
measure: Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS)
timeFrame: at 3 months and 6 months
Other outcomes:
Locations:
city: Unterhautzenthal
country: Austria
facility: Ordination
city: Vienna
country: Austria
facility: Ordination
city: Bexbach
country: Germany
facility: Medical Practice
city: Deggingen
country: Germany
facility: Medical Practice
city: Frankfurt
country: Germany
facility: Medical Practice
city: Görlitz
country: Germany
facility: Medical Practice
city: Leipzig
country: Germany
facility: AmBeNet GmbH
Study officials:
References: