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

NCT05000541 | Completed

• 1 other identifier: 3319
• Study Type: observational
• Target: 259
• Locations: 2 countries
• Sites: 7

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in LDL-C

  Mean change from baseline in LDL-C at 3 months

  3 months

Secondary Outcomes (1)

• Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS)

  at 3 months and 6 months

Study Arms (1)

Armolipid-L/Armolipid Plus-L

Armolipid-L used for participants in Germany and Poland Armolipid Plus-L used for participants in Austria

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan Österreich GmbH: collaborator
• Mylan Germany GmbH: collaborator
• Mylan Healthcare Sp. z o.o.: collaborator

Study Sites (7)

Ordination

Unterhautzenthal, 2011, Austria

Location

Ordination

Vienna, 1140, Austria

Location

Medical Practice

Bexbach, 66450, Germany

Location

Medical Practice

Deggingen, 73326, Germany

Location

Medical Practice

Frankfurt, 60598, Germany

Location

Medical Practice

Görlitz, 02827, Germany

Location

AmBeNet GmbH

Leipzig, 04107, Germany

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 11, 2021
• Study Start: December 8, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-04

Locations

AU (2); DE (5)