Clinical trial NCT02912325: Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS
Official title: A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: MDM S.p.A.
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2016-09-23
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

Primary outcomes:
measure: Serum lipidemic profile evaluated at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Serum lipidemic profile evaluated at 3 months
timeFrame: 3 months
measure: AE/SAE (with particular regards for gastrointestinal symptoms)
timeFrame: 6 months
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Opera Contract Research Organization SRL
state: Timis
city: Timişoara
country: Romania
facility: Scm Dr Rosu
state: Timis
Study officials:
affiliation: MDM SpA Italy
name: Antonio Maggi, MD
role: STUDY_DIRECTOR
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