Non-Comparative Study to Assess the Efficacy & Safety of the New Food

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02912325
Study type	Interventional
Source	MDM S.p.A.
Contact
Status	Completed
Phase	N/A
Start date	May 9, 2017
Completion date	June 11, 2018

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms