Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia

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 2012, 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 the tested nutraceutical
• Women in fertile age not using consolidated contraceptive methods
• Pregnancy and Breastfeeding.