Evaluation of the Effect of a Food Supplementation With Eufortyn Colesterolo Plus on the Modulation of LDL Cholesterolemia in Subjects Affected by Polygenic Hypercholesterolemia: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.

University of Bologna1 site in 1 country60 target enrollmentSeptember 14, 2020

ConditionsHypercholesterolemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypercholesterolemia
Sponsor: University of Bologna
Enrollment: 60
Locations: 1
Primary Endpoint: The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.

The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL cholesterolemia compared with placebo.

Registry

clinicaltrials.gov

Start Date

September 14, 2020

End Date

January 19, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Bologna

Responsible Party

Principal Investigator

Arrigo F.G. Cicero

Professor

University of Bologna

Eligibility Criteria

Inclusion Criteria

•Subjects agree to participate in the study and having dated and signed the informed consent form.
•Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
•Male or female aged ≥ 18 years and ≤ 70 years old.
•LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL.
•TG\<400 mg/dL.
•Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2019, the intervention strategy does not require a pharmacological lipid lowering intervention.

Exclusion Criteria

•Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 5%;
•Obesity (BMI\>30 kg/m2) or diabetes mellitus;
•Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
•Antihypertensive treatment not stabilized since at least 3 months;
•Anticoagulants therapy
•Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
•Known current thyroid, gastrointestinal or hepatobiliary diseases;
•Any medical or surgical condition that would limit the patient adhesion to the study protocol;
•Abuse of alcohol or drugs (current or previous);
•History of malignant neoplasia in the 5 years prior to enrolment in the study;

Outcomes

Primary Outcomes

The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).

Time Frame: 8 weeks