- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813914
A New Supplement for the "Metabolic Syndrome"
January 21, 2019 updated by: Rosario D'anna, University of Messina
Corosolic Acid and Cinnamon for the Treatment of the "Metabolic Syndrome" in Menopausal Transition Women
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sineos
Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months
|
glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day
|
PLACEBO_COMPARATOR: Placebo comparator
placebo 2 pills/day for 3 months
|
glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in glycemia
Time Frame: 3 months
|
Reduction of glycemia (mg/dl)
|
3 months
|
Changes in HDL-cholesterol
Time Frame: 3 months
|
Increase of HDL-C (mg/dl)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in HOMA-IR
Time Frame: 3 months
|
measured as the ratio between glycaemia (mg/dl) and insulin (UI)
|
3 months
|
changes in total-cholesterol
Time Frame: 3 months
|
reduction of cholesterol (mg/dl)
|
3 months
|
changes in triglycerides
Time Frame: 3 months
|
reduction in triglycerides (mg/dl)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2017
Primary Completion (ACTUAL)
January 15, 2018
Study Completion (ACTUAL)
June 30, 2018
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
January 21, 2019
First Posted (ACTUAL)
January 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 21, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sineos-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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