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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-08

Study Completion Date

2023-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Armolipid-L/Armolipid Plus-L

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No