Hypercholesterolemia
Conditions
Keywords
Atherosclerosis, Carotid, Lipid profile
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).
Interventions
DIETARY_SUPPLEMENTLiposcudil Plus
Sponsors
Marcello Rattazzi
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
Countries
Italy
Outcome results
None listed