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

NCT02912325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-10-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • MDM S.p.A.

    lead OTHER

Principal Investigators

  • Antonio Maggi, MD · MDM SpA Italy

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2017-10-15
Completion
2018-06-11

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912325 on ClinicalTrials.gov