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

M

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

FaseMetS ® a food supplement
Other group
Description:
Daily administration: 2 tablets FaseMETS a day
Treatment:
Dietary Supplement: Daily administration: 2 tablets FaseMETS a day

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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