A New Supplement for the "Metabolic Syndrome"

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

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Sineos

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

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.

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

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	Dietary supplement: Sineos; 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	Dietary supplement: Sineos; 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	Reduction of glycemia (mg/dl)	3 months
Changes in HDL-cholesterol	Increase of HDL-C (mg/dl)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in HOMA-IR	measured as the ratio between glycaemia (mg/dl) and insulin (UI)	3 months
changes in total-cholesterol	reduction of cholesterol (mg/dl)	3 months
changes in triglycerides	reduction in triglycerides (mg/dl)	3 months

Collaborators and Investigators

• Sponsor: University of Messina

Study record dates

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: insulin resistance, blood pressure,
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• 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