A New Supplement for the "Metabolic Syndrome"

Metabolic Syndrome Clinical Trial

Official title:

Corosolic Acid and Cinnamon for the Treatment of the "Metabolic Syndrome" in Menopausal Transition Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03813914
• Other study ID #: Sineos-3
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Sineos
glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glycemia	Reduction of glycemia (mg/dl)	3 months
Primary	Changes in HDL-cholesterol	Increase of HDL-C (mg/dl)	3 months
Secondary	changes in HOMA-IR	measured as the ratio between glycaemia (mg/dl) and insulin (UI)	3 months
Secondary	changes in total-cholesterol	reduction of cholesterol (mg/dl)	3 months
Secondary	changes in triglycerides	reduction in triglycerides (mg/dl)	3 months