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临床试验/NCT04866628
NCT04866628已完成不适用

Comparison of Helichrysum Italicum Infusion and Helichrysum Arenarium Infusion Effects on the Components of Metabolic Syndrome in Adults

University of Primorska2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Lipid profile

研究概览

简要总结

The study evaluates the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome. The components of metabolic syndrome will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.

详细描述

Helichrysum arenarium (HA) has a long tradition in European ethno-medicine as a medicinal plant with many known activities; EU monograph supports its use for the digestive disorders, feeling of fullness and bloating, and, importantly, it re-ports no side effects. Assessment report of the European Medicines Agency Committee on Herbal Medicinal Products supports its stimulatory role in the bile flow and in the release of cholesterol to the bile. HA has also been used in chronic liver inflammatory disease and as a scavenger of free radicals. Similar to HA Helichrysum italicum (HI) is widely used in traditional medicine. Lately, much attention has been given to natural antioxidants and their ability to delay the progression of chronic diseases related to the formation and the activity of reactive oxygen species and other free radicals. Herbs are very often used to prepare recreational tea and are thereby important sources of antioxidants in different cultures. In traditional medicine, HI is also used in diet, mainly for the preparation of infusions in treating respiratory and digestive conditions.

Therefore,the ail of our study is to evaluate the effects of Helichrysum italicum and Helichrysum Arenarium on different components of the metabolic syndrome in adults presenting at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, antrophometry, inflammation status, glucose levels) will be measured at baseline and four weeks after daily consumptions of either Helichrysum italicum or either Helichrysum Arenarium, and after two weeks of washout. In addition, stool samples will be also taken at baseline and after four weeks of daily consumtion of either Helichrysum italicum or either Helichrysum Arenarium.

研究设计

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

入排标准

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

入选标准

  • stable weight in the last 3 months
  • BMI more than 25
  • clinical diagnosis of at least two components of metabolic syndrome,

排除标准

  • consumption of dietary supplements
  • medications for any component of metabolic syndrome

结局指标

主要结局

Lipid profile

时间窗: changes from baseline to four weeks of daily consumption and after two weeks of washout

Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides will be examined with biochemical analyzer Cobass

次要结局

  • Blood pressure(changes from baseline to four weeks of daily consumption and after two weeks of washout)
  • Inflammation(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
  • Microbiota(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
  • Antioxidative potential(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
  • Anthropometric measurements Description:(Chages from baseline to four weeks of daily consumption and after two weeks of washout)
  • Anthropometric measurements(Chages from baseline to four weeks of daily consumption and after two weeks of washout)

研究者

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

Zala Jenko Praznikar

Associate professor

University of Primorska

研究点 (2)

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