NCT02912325CompletedNot Applicable
A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome
MDM S.p.A.2 sites in 1 country34 target enrollmentStarted: May 9, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Serum lipidemic profile evaluated at 6 months
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
FaseMetS ® a food supplement
Other
Daily administration: 2 tablets FaseMETS a day
Intervention: Daily administration: 2 tablets FaseMETS a day (Dietary Supplement)
Outcomes
Primary Outcomes
Serum lipidemic profile evaluated at 6 months
Time Frame: 6 months
laboratory test
Secondary Outcomes
- AE/SAE (with particular regards for gastrointestinal symptoms)(6 months)
- Serum lipidemic profile evaluated at 3 months(3 months)
Investigators
Study Sites (2)
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