ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02912325
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
MDM S.p.A.

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Daily administration: 2 tablets FaseMETS a day Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : October 15, 2017
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Serum lipidemic profile evaluated at 6 months [ Time Frame: 6 months ]
    laboratory test


Secondary Outcome Measures :
  1. Serum lipidemic profile evaluated at 3 months [ Time Frame: 3 months ]
    laboratory test

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men or women
  • age > 45 and ≤70 years
  • on cardiovascular disease prevention in clinical practice
  • written informed consent.
  • total cholesterol≥240 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≥30 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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912325


Contacts
Contact: Dionisio Barattini, MD +393355437574 barattini@operacro.com
Contact: Serban Rosu, MD rosu@operacro.com

Locations
Romania
Opera Contract Research Organization SRL Recruiting
Timisoara, Timis, Romania, 300209
Contact: Barattini Dionisio, MD    +393355437574    barattini@operacro.com   
Scm Dr Rosu Recruiting
Timişoara, Timis, Romania, 300209
Contact: Doina Rosu, MD       dr_doinarosu@yahoo.com   
Sponsors and Collaborators
MDM S.p.A.
Opera Contract Research Organization SRL
Investigators
Study Director: Antonio Maggi, MD MDM SpA Italy

Publications:

Responsible Party: MDM S.p.A.
ClinicalTrials.gov Identifier: NCT02912325     History of Changes
Other Study ID Numbers: OPMDM/0216/FS
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases