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

NCT02912325 | Completed DMC

• 1 other identifier: OPMDM/0216/FS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Serum lipidemic profile evaluated at 6 months

  laboratory test

  6 months

Secondary Outcomes (2)

• Serum lipidemic profile evaluated at 3 months

  3 months

• AE/SAE (with particular regards for gastrointestinal symptoms)

  6 months

Study Arms (1)

FaseMetS ® a food supplement

OTHER

Daily administration: 2 tablets FaseMETS a day

Dietary Supplement: Daily administration: 2 tablets FaseMETS a day

Interventions

Daily administration: 2 tablets FaseMETS a day DIETARY_SUPPLEMENT

Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome

FaseMetS ® a food supplement

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MDM S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (2)

Opera Contract Research Organization SRL

Timișoara, Timiș County, 300209, Romania

Location

Scm Dr Rosu

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (18)

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  PMID: 16875966 BACKGROUND

• Alsheikh-Ali AA, Karas RH. The relationship of statins to rhabdomyolysis, malignancy, and hepatic toxicity: evidence from clinical trials. Curr Atheroscler Rep. 2009 Mar;11(2):100-4. doi: 10.1007/s11883-009-0016-8.

  PMID: 19228482 BACKGROUND

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  PMID: 19528564 BACKGROUND

• Rondanelli M, Giacosa A, Orsini F, Opizzi A, Villani S. Appetite control and glycaemia reduction in overweight subjects treated with a combination of two highly standardized extracts from Phaseolus vulgaris and Cynara scolymus. Phytother Res. 2011 Sep;25(9):1275-82. doi: 10.1002/ptr.3425. Epub 2011 Feb 10.

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  PMID: 25392114 BACKGROUND

• Bunnoy A, Saenphet K, Lumyong S, Saenphet S, Chomdej S. Monascus purpureus-fermented Thai glutinous rice reduces blood and hepatic cholesterol and hepatic steatosis concentrations in diet-induced hypercholesterolemic rats. BMC Complement Altern Med. 2015 Mar 28;15:88. doi: 10.1186/s12906-015-0624-5.

  PMID: 25880551 BACKGROUND

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  PMID: 25115132 BACKGROUND

• Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8.

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MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonio Maggi, MD

  MDM SpA Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 23, 2016
• Study Start: May 9, 2017
• Primary Completion: October 15, 2017
• Study Completion: June 11, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2)