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A New Supplement for the "Metabolic Syndrome"

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sineos
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring insulin resistance, blood pressure,

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.

-

Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sineos

    Placebo comparator

    Arm Description

    Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months

    placebo 2 pills/day for 3 months

    Outcomes

    Primary Outcome Measures

    Changes in glycemia
    Reduction of glycemia (mg/dl)
    Changes in HDL-cholesterol
    Increase of HDL-C (mg/dl)

    Secondary Outcome Measures

    changes in HOMA-IR
    measured as the ratio between glycaemia (mg/dl) and insulin (UI)
    changes in total-cholesterol
    reduction of cholesterol (mg/dl)
    changes in triglycerides
    reduction in triglycerides (mg/dl)

    Full Information

    First Posted
    August 7, 2018
    Last Updated
    January 21, 2019
    Sponsor
    University of Messina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813914
    Brief Title
    A New Supplement for the "Metabolic Syndrome"
    Official Title
    Corosolic Acid and Cinnamon for the Treatment of the "Metabolic Syndrome" in Menopausal Transition Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2017 (Actual)
    Primary Completion Date
    January 15, 2018 (Actual)
    Study Completion Date
    June 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Messina

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid for the treatment of metabolic syndrome. Participants receive the supplement or a placebo.
    Detailed Description
    The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid. They act in different way reducing insulin resistance, which is the main cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were the improvement of the parameters that characterizes the metabolic syndrome, such as glucose and insulin levels, triglycerides, HDL-cholesterol and blood pressure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    insulin resistance, blood pressure,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sineos
    Arm Type
    Experimental
    Arm Description
    Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months
    Arm Title
    Placebo comparator
    Arm Type
    Placebo Comparator
    Arm Description
    placebo 2 pills/day for 3 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sineos
    Intervention Description
    glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day
    Primary Outcome Measure Information:
    Title
    Changes in glycemia
    Description
    Reduction of glycemia (mg/dl)
    Time Frame
    3 months
    Title
    Changes in HDL-cholesterol
    Description
    Increase of HDL-C (mg/dl)
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    changes in HOMA-IR
    Description
    measured as the ratio between glycaemia (mg/dl) and insulin (UI)
    Time Frame
    3 months
    Title
    changes in total-cholesterol
    Description
    reduction of cholesterol (mg/dl)
    Time Frame
    3 months
    Title
    changes in triglycerides
    Description
    reduction in triglycerides (mg/dl)
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria. - Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A New Supplement for the "Metabolic Syndrome"

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