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

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT05000541
• Lead Sponsor: Mylan Inc.

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.

Study Timeline

• Study Start: 2020-12-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-11
• Status Verified: 2023-04
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in LDL-C	3 months	Mean change from baseline in LDL-C at 3 months

Secondary Outcome Measures

Name	Time	Method
Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS)	at 3 months and 6 months	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

Trial Locations

Locations (3)

AmBeNet GmbH; 🇩🇪 Leipzig, Germany

Medical Practice; 🇩🇪 Görlitz, Germany

Ordination; 🇦🇹 Vienna, Austria