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

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia

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.

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Austria
  • Unterhautzenthal, Austria, 2011
    • Ordination
  • Vienna, Austria, 1140
    • Ordination
• Germany
  • Bexbach, Germany, 66450
    • Medical Practice
  • Deggingen, Germany, 73326
    • Medical Practice
  • Frankfurt, Germany, 60598
    • Medical Practice
  • Görlitz, Germany, 02827
    • Medical Practice
  • Leipzig, Germany, 04107
    • AmBeNet GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Armolipid-L/Armolipid Plus-L; Armolipid-L used for participants in Germany and Poland Armolipid Plus-L used for participants in Austria

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: Mylan Österreich GmbH; Mylan Germany GmbH; Mylan Healthcare Sp. z o.o.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 3319

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No