Back to resultsNon-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Daily administration: 2 tablets FaseMETS a day
Sponsored by
About this trial
This is an interventional other trial for Metabolic Syndrome
Eligibility 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.
Sites / Locations
- Opera Contract Research Organization SRL
- Scm Dr Rosu
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
FaseMetS ® a food supplement
Arm Description
Daily administration: 2 tablets FaseMETS a day
Outcomes
Primary Outcome Measures
Serum lipidemic profile evaluated at 6 months
laboratory test
Secondary Outcome Measures
Serum lipidemic profile evaluated at 3 months
laboratory test
AE/SAE (with particular regards for gastrointestinal symptoms)
blood clinical laboratory parameters
physical examination including weight, systolic blood pressure and diastolic blood pressure
Full Information
NCT ID
NCT02912325
First Posted
September 12, 2016
Last Updated
September 30, 2019
Sponsor
MDM S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
1. Study Identification
Unique Protocol Identification Number
NCT02912325
Brief Title
Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS
Official Title
A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
June 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MDM S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FaseMetS ® a food supplement
Arm Type
Other
Arm Description
Daily administration: 2 tablets FaseMETS a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Daily administration: 2 tablets FaseMETS a day
Intervention Description
Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome
Primary Outcome Measure Information:
Title
Serum lipidemic profile evaluated at 6 months
Description
laboratory test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum lipidemic profile evaluated at 3 months
Description
laboratory test
Time Frame
3 months
Title
AE/SAE (with particular regards for gastrointestinal symptoms)
Description
blood clinical laboratory parameters
physical examination including weight, systolic blood pressure and diastolic blood pressure
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Maggi, MD
Organizational Affiliation
MDM SpA Italy
Official's Role
Study Director
Facility Information:
Facility Name
Opera Contract Research Organization SRL
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300209
Country
Romania
Facility Name
Scm Dr Rosu
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300209
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
No
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Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS
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