A New Supplement for the "Metabolic Syndrome"
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sineos
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring insulin resistance, blood pressure,
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
-
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
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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