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临床试验/NCT04818905
NCT04818905已完成不适用

Effects of Helichrysum Italicum Infusion on Resting Energy Expenditure and Fat Oxidation in Humans

University of Primorska2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年6月15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
11
试验地点
2
主要终点
Respiratory quotient

研究概览

简要总结

The study evaluates the acute effects of Helichrysum italicum on resting energy expenditure and substrate oxidation in humans. The resting energy expenditure and substrate oxidation will be measured by indirect calorimetry at baseline and after ingestion of either Helichrysum italicum infusion or hot water.

详细描述

Bioactive compounds found in medicinal plants and plant extracts, such as polyphenols, represent the oldest and most widely used form of alternative or complementary treatments for the prevention and management of obesity. Their consumption is currently increasing in the population due to the high cost, potential adverse effects and limited benefits of currently available pharmaceutical drugs. Helichrysum italicum is a mediterranean plant with promising nutraceutical activities. The plant is known as a rich source of biologically active compounds such as polyphenolic antioxidants, which are recognized in the prevention of various non-communicable chronic diseases. However, most of its traditionally claimed uses have not yet been scientifically proven.

The proposed study will investigate the acute effect of Helichrysum italicum infusion on resting energy expenditure, substrate oxidation, respiratory quotient and blood pressure in a pilot study of 11 male adults. It will be designed as a crossover study. Half of the participants will consume the Helichrysum italicum infusion and the other half will consume hot water. After seven days of washout period the participants will consume the alternate beverage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy, weight-stable (±3 kg in the last 3 months), normotensive, non-smokers, no use of dietary supplements or frequent use of medication and no known metabolic disorders.

排除标准

  • females, smoking, medications, dietary supplements, metabolic diseases, hypertensive

结局指标

主要结局

Respiratory quotient

时间窗: Change from baseline to 30 minutes and 120 minutes.

Respiratory quotient will be determined with indirect calorimetry.

Changes in fat oxidation

时间窗: Change from baseline to 30 minutes and 120 minutes.

Substrate oxidation will be determined with indirect calorimetry.

Change in resting energy expenditure

时间窗: Change from baseline to 30 minutes and 120 minutes.

Resting energy expenditure will be determined with indirect calorimetry.

Blood pressure

时间窗: Change from baseline to 30 minutes and 120 minutes.

Systolic and diastolic blood pressures will be determined with blood pressure device (Omron M3)

次要结局

未报告次要终点

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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