跳至主要内容
临床试验/NCT06896175
NCT06896175招募中不适用

Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile of Consumes in the Department of Caaguazu, Paraguay

Universidad Nacional de Caaguazu1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
198
试验地点
1
主要终点
Effect on lipid profile

研究概览

简要总结

Introduction: This project studies the impact of Ilex paraguariensis harvest time, commonly known as yerba mate, and its consumption mode (mate, tereré, and mate/terere) on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Yerba mate is rich in bioactive compounds such as polyphenols, xanthines, and saponins. There are no clinical trials conducted in Paraguay with our Ilex paraguariensis plantations that have analyzed the influence of harvest time on the yerba mate production process and the infusion mode, in relation to its effect on dyslipidemias. General Objective: To establish the effectiveness of Ilex paraguariensis harvest time and the mode of consumption of the produced yerba mate on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Methodology: The research approach will be quantitative, using a triple-blind randomized clinical trial design. Participants will be regular consumers of yerba mate, divided into groups based on harvest time (beginning or end of the harvest) and consumption mode (mate, tereré, or both). Lipid profile measurements will be taken at baseline and at 30, 90, and 180 days after consumption. Yerba mate samples will be analyzed and classified according to their bioactive properties before being blinded to the researchers and participants. Expected results: a report on the social, cultural, and anthropometric characterization of regular consumers of mate and tereré, and a report on the concentrations of the bioactive properties of yerba mate; polyphenols, xanthines, saponins from Ilex paraguariensis harvested at the beginning and end of the harvest and the database of patients with baseline lipid profile results, at 30, 90, and 180 days of mate and tereré consumers with yerba mate prepared randomly according to the harvest time of the Ip (beginning or end of harvest) analyzed.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

They will not distinguished if the yerba is the harvested before or after the safra period

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals of both sexes, between 18 and 60 years of age, residing in the country, who consume prepared yerba mate.
  • Consumers of mate or tereré and mate/terere who agree to consume the yerba mate samples provided by the research team, which will be masked from laboratory analysis.
  • Two weeks of abstinence from consuming prepared yerba mate, either as mate or tereré, prior to randomization for the trial.
  • Consume exclusively prepared yerba mate in the prescribed manner (quantity of yerba, frequency of consumption, and sips), either in its mate or tereré form independently, and for those who consume both forms daily.
  • Do not change the yerba mate consumer's usual diet or regular physical activity during the trial period.
  • Agree to know the laboratory results of the lipid profile only at the end of the trial (180 days after the start).

排除标准

  • Individuals receiving lipid-lowering treatment at the start of the trial.
  • Consuming any other type of yerba mate not provided by the principal investigator.
  • Individuals requiring vitamins as a nutritional supplement.
  • Individuals taking thermogenic supplements.
  • Individuals consuming cooked mate.
  • Addiction to medicinal plants or herbs, both mate and tereré.
  • Individuals with a personal history of coronary artery disease.

研究组 & 干预措施

YM terere

Active Comparator

Yerba mate terere consumption only

干预措施: Yerba mate comsuption (ilex paraguayencis) B (Dietary Supplement)

YM mate and terere

Experimental

Yerba mate consuptiom as mate and terere

干预措施: Yerba mate consumption (Ilex paraguayensis) A (Dietary Supplement)

YM mate

Active Comparator

Yerba consumption of mate only

干预措施: Yerba mate consumption (Ilex paraguayensis) A (Dietary Supplement)

YM mate

Active Comparator

Yerba consumption of mate only

干预措施: Yerba mate comsuption (ilex paraguayencis) B (Dietary Supplement)

YM terere

Active Comparator

Yerba mate terere consumption only

干预措施: Yerba mate consumption (Ilex paraguayensis) A (Dietary Supplement)

YM mate and terere

Experimental

Yerba mate consuptiom as mate and terere

干预措施: Yerba mate comsuption (ilex paraguayencis) B (Dietary Supplement)

结局指标

主要结局

Effect on lipid profile

时间窗: six months

Effect of total cholesterol, LDL, HDL and tryglicerids

次要结局

未报告次要终点

研究者

发起方
Universidad Nacional de Caaguazu
申办方类型
Other
责任方
Sponsor

研究点 (1)

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