Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia

Launched by UNIVERSITY OF BOLOGNA · Sep 28, 2020

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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;
• • History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
• • History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
• • Known previous intolerance to one component of the tested nutraceuticals
• • Women in fertile age not using consolidated contraceptive methods
• • Pregnancy and Breastfeeding.