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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000541
• Other study ID #: 3319
• Status: Completed
• Start date: December 8, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
Austria	Ordination	Unterhautzenthal
Austria	Ordination	Vienna
Germany	Medical Practice	Bexbach
Germany	Medical Practice	Deggingen
Germany	Medical Practice	Frankfurt
Germany	Medical Practice	Görlitz
Germany	AmBeNet GmbH	Leipzig

Sponsors (4)

Lead Sponsor	Collaborator
Mylan Inc.	Mylan Germany GmbH, Mylan Healthcare Sp. z o.o., Mylan Österreich GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in LDL-C	Mean change from baseline in LDL-C at 3 months	3 months
Secondary	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