A New Supplement for the "Metabolic Syndrome"
- Conditions
- Metabolic Syndrome
- Interventions
- Dietary Supplement: Sineos
- Registration Number
- NCT03813914
- Lead Sponsor
- University of Messina
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.
treatment with steroids or with hypoglycemic or anti-cholesterol drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sineos Sineos Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months Placebo comparator Sineos placebo 2 pills/day for 3 months
- Primary Outcome Measures
Name Time Method Changes in glycemia 3 months Reduction of glycemia (mg/dl)
Changes in HDL-cholesterol 3 months Increase of HDL-C (mg/dl)
- Secondary Outcome Measures
Name Time Method changes in total-cholesterol 3 months reduction of cholesterol (mg/dl)
changes in triglycerides 3 months reduction in triglycerides (mg/dl)
changes in HOMA-IR 3 months measured as the ratio between glycaemia (mg/dl) and insulin (UI)