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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912325
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Opera CRO, a TIGERMED Group Company
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
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 9, 2017
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine


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.


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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 ≤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.

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


Locations
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Romania
Opera Contract Research Organization SRL
Timisoara, Timis, Romania, 300209
Scm Dr Rosu
Timişoara, Timis, Romania, 300209
Sponsors and Collaborators
MDM S.p.A.
Opera CRO, a TIGERMED Group Company
Investigators
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Study Director: Antonio Maggi, MD MDM SpA Italy

Publications:

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Responsible Party: MDM S.p.A.
ClinicalTrials.gov Identifier: NCT02912325    
Other Study ID Numbers: OPMDM/0216/FS
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases