Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels

Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo-controlled, Randomized, Clinical Trial

The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.

Inclusion Criteria:

The subjects will have to meet all the following inclusion criteria:

1. Subjects agree to participate in the study and having dated and signed the informed consent form.
2. Male or female aged ≥ 18 years and ≤ 70 years old.
3. LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
4. TG<400 mg/dL.
5. 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.
6. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.

Exclusion Criteria:

Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:

1. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk > 5%;
2. Obesity (BMI>30 kg/m2) or diabetes mellitus;
3. Assumption of lipid-lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
4. Antihypertensive treatment not stabilized for at least 3 months;
5. Anticoagulant therapy
6. Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
7. Known current thyroid, gastrointestinal or hepatobiliary diseases;
8. Any medical or surgical condition that would limit the participant adhesion to the study protocol;
9. Abuse of alcohol or drugs (current or previous);
10. History of malignant neoplasia in the 5 years prior to enrolment in the study;
11. History or clinical evidence of inflammatory diseases such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
12. History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
13. Known previous intolerance to one component of the tested nutraceuticals or to one of these plant species: Asteraceae or Compositae;
14. Women in fertile age not using consolidated contraceptive methods
15. Pregnancy and Breastfeeding.