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临床试验/NCT03813914
NCT03813914已完成不适用

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

University of Messina0 个研究点目标入组 60 人开始时间: 2017年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Changes in glycemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.

排除标准

  • treatment with steroids or with hypoglycemic or anti-cholesterol drugs

研究组 & 干预措施

Sineos

Experimental

Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months

干预措施: Sineos (Dietary Supplement)

Placebo comparator

Placebo Comparator

placebo 2 pills/day for 3 months

干预措施: Sineos (Dietary Supplement)

结局指标

主要结局

Changes in glycemia

时间窗: 3 months

Reduction of glycemia (mg/dl)

Changes in HDL-cholesterol

时间窗: 3 months

Increase of HDL-C (mg/dl)

次要结局

  • changes in total-cholesterol(3 months)
  • changes in triglycerides(3 months)
  • changes in HOMA-IR(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosario D'anna

Principal Investigator, Clinical professor

University of Messina

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