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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05000541

Enrollment

259

Registered

2021-08-11

Start date

2020-12-08

Completion date

2023-10-31

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean change from baseline in LDL-C	3 months	Mean change from baseline in LDL-C at 3 months

Secondary

Measure	Time frame	Description
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

Countries

Austria, Germany

Outcome results