Nutraceuticals and Vascular Remodelling

Study Overview
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Brief Summary
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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).

Official Title
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Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice.

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Liposcudil Plus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RYR plus CoQ<br>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 | Dietary Supplement: Liposcudil Plus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cholesterol levels at one year | Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl | Baseline and one year | 
| Change from baseline in carotid intima media thickening at 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 . | Baseline and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Carotid, Lipid profile