Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

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

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

Detailed description: 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: Inclusion Criteria:
  -  men or women
  -  age > 45 and ≤70 years
  -  on cardiovascular disease prevention in clinical practice
  -  written informed consent.
  -  total cholesterol≥240 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≥30 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)
  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.

Relevance to patient case: not relevant