non-comparative study to assess the efficacy and safety of the new food supplement fasemets

Conditions: Metabolic Syndrome

Summary: the primary objective is to evaluate the efficacy of fasemets for 6 consecutive months in lowering serum lipids and glucose in subjects with metabolic syndrome; the secondary objectives of the trial are: * to evaluate the potential benefit after 3 months of therapy (by an interim analysis) * to evaluate the safety of 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

Eligibility criteria:
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.