Lipid Profile and Vascular Remodelling in Young Dyslipidemic Subjects Treated With Nutraceuticals Derived From Red Yeast Rice. (MALTRO)

NCT04433429 COMPLETED

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).

Details

Lead sponsor	Marcello Rattazzi
Status	COMPLETED
Enrolment	30
Start date	2016-05
Completion	2017-12

Conditions

• Hypercholesterolemia

Interventions

• Liposcudil Plus

Primary outcomes

• 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