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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04433429
Other study ID # 3497/AO/15
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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