Skip to main content
OpenTrials
Completed

NCT Number: NCT04433429

Nutraceuticals and Vascular Remodelling

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera di Padova

Padova, 35125, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposcudil Plus

Dietary Supplement

Primary outcomes

  1. Change from baseline in cholesterol levels at one year

    Time frame: Baseline and one year

    Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl

  2. Change from baseline in carotid intima media thickening at one year

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Marcello Rattazzi

Other

Registry information

Official study title

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

Acronym: MALTRO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.