Nutraceuticals and Vascular Remodelling

Hypercholesterolemia Clinical Trial

— MALTRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433429
• Other study ID #: 3497/AO/15
• Status: Completed
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2020
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Vascular Remodeling

Intervention

Dietary Supplement:
• Liposcudil Plus

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Marcello Rattazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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