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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Daily administration: 2 tablets FaseMETS a day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FaseMetS ® a food supplement<br>Daily administration: 2 tablets FaseMETS a day | Dietary Supplement: Daily administration: 2 tablets FaseMETS a day<br>* Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipidemic profile evaluated at 6 months | laboratory test | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipidemic profile evaluated at 3 months | laboratory test | 3 months | 
| AE/SAE (with particular regards for gastrointestinal symptoms) | blood clinical laboratory parameters physical examination including weight, systolic blood pressure and diastolic blood pressure | 6 months |