Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS

The trial is designed as a multicenter, open label, non-comparative, 6 months, pilot study.

The primary objective is to evaluate the efficacy of FaseMetS ® administered for 6 months treatment combined with a health management plan in reducing the serum lipidemic profile (this includes total cholesterol, LDL cholesterol, HDL cholesterol, small density LDL particles, triglycerides, serum glucose, glycated haemoglobin (HBA1c), insulin, and pro-insulin, HOMA index, uric acid, body mass index (BMI), creatine phosphokinase) in patients diagnosed with Metabolic Syndrome and with mild to moderate Hypercholesterolemia.

The secondary objectives are:

• to evaluate the efficacy in reducing the serum lipidemic profile after a period of 3 months of FaseMetS ® ® treatment;
• to evaluate the safety of FaseMetS ® treatment by recording AE/SAE (with particular regards for gastrointestinal symptoms);
• improvement of blood clinical laboratory parameters;
• improvement of weight control systolic blood pressure and diastolic blood pressure control

Inclusion criteria

• men or women
• age > 45 and ≤75 years
• on cardiovascular disease prevention in clinical practice
• written informed consent.
• total cholesterol≥200 mg/dL
• diagnosis of metabolic syndrome with three or more of the following:

• Waist circumference: ≥89 cm for women and ≥102 cm for men or BMI≥25 Kg/m2;
• Triglycerides level: ≥ 175 mg/dL or 1.7 mmol/L
• HDL <40 mg/dL (1.04 mmol/L) in men or <50 mg/dL (1.3 mmol/L) in women
• Blood sugar (fasting plasma glucose): ≥120 mg/dL (6.7 mmol/L)
• Elevated blood pressure: systolic ≥ 130 and/or diastolic ≥ 85 mm Hg (antihypertensive drug treatment in a patient with a history of hypertension is an alternate indicator).

Exclusion criteria

• Pregnancy or lactation;
• Patients at very high or low cardiovascular risk, having a calculated SCORE ≥10% or <1% respectively
• History of atrial fibrillation or atrial flutter
• Patient in treatment with indication to oral anticoagulants or other antithrombotic drugs
• Patients with severe gastro-intestinal tract disorders with possible influence on drug absorption or electrolytes.
• Patients with myeloproliferative disorders
• Patients with severe chronic kidney disease (GFR 30 mL/min/ 1.73 m2), using Cockcroft's formula, with known liver disease or biliary obstructive disorders, chronic hepatitis, cirrhosis, with hyperkalemia or with ALAT or ASAT upper than 3 times the upper limit of normal laboratory range.
• History of alcoholism or drug abuse.
• Uncontrolled dysthyroidism, Cushing's syndrome, acromegalia, hyperparathyroidism.
• Patients with HIV or taking drugs for HIV.
• Patients taking statins or other dyslipidemic /hypolipidemic agents (drugs, food supplements, etc).
• Patients taking antidiabetic drugs (i.e metformin, acarbose and/or others).
• Patients unlikely to co-operate in the study or to comply well with treatment or with the study visits.
• Participation in another study at the same time or within the preceding 30 days.