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

September 30, 2019 updated by: MDM S.p.A.

A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300209
        • Opera Contract Research Organization SRL
      • Timişoara, Timis, Romania, 300209
        • Scm Dr Rosu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FaseMetS ® a food supplement
Daily administration: 2 tablets FaseMETS a day
Dietary supplement: Daily administration: 2 tablets FaseMETS a day
Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum lipidemic profile evaluated at 6 months
Time Frame: 6 months
laboratory test
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum lipidemic profile evaluated at 3 months
Time Frame: 3 months
laboratory test
3 months
AE/SAE (with particular regards for gastrointestinal symptoms)
Time Frame: 6 months
  • blood clinical laboratory parameters
  • physical examination including weight, systolic blood pressure and diastolic blood pressure
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDM S.p.A.

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Study Director: Antonio Maggi, MD, MDM SpA Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Actual)

October 15, 2017

Study Completion (Actual)

June 11, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPMDM/0216/FS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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