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

MDM S.p.A.

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Daily administration: 2 tablets FaseMETS a day

Study type

Interventional

Funder types

Other

Identifiers

NCT02912325

OPMDM/0216/FS

Details and patient eligibility

About

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

Full 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

Enrollment

34 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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.