Nutraceuticals and Vascular Remodelling

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Liposcudil Plus

• Registration Number: NCT04433429
• Lead Sponsor: Marcello Rattazzi

Brief Summary

Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Total Cholesterol > 150 mg/dl and < 250 mg/dl;
• Triglycerides > 150 mg/dl and < 500 mg/dl;
• Fasting glucose < 126 mg/dl;
• Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.

Exclusion Criteria

• Total Cholesterol > 250 mg/dl
• Triglycerides > 500 mg/dl
• Previous statin therapy (last 6 months);
• Treatment with hypoglycemic agents and/or fasting glucose > 126 mg/dl;
• Chronic gastrointestinal disorders;
• Chronic kidney disease (eGFR < 60 ml/min/1.73 m2);
• Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
• Proven intolerance to any component of the nutraceutical product;
• Pregnancy or breastfeeding.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RYR plus CoQ	Liposcudil Plus	333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in cholesterol levels at one year	Baseline and one year	Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl
Change from baseline in carotid intima media thickening at one year	Baseline and one year	Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment .

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy