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NCT Number: NCT06896175

Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNCA

Coronel Oviedo, Paraguay

Location status: Recruiting

Location contact

Gloria Gonzalez

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Yerba mate consumption (Ilex paraguayensis) A

Dietary Supplement

Yerba mate of the begining of the harvest time

Yerba mate comsuption (ilex paraguayencis) B

Dietary Supplement

Yerba mate of the final time of the harvest

Primary outcomes

  1. Effect on lipid profile

    Time frame: six months

    Effect of total cholesterol, LDL, HDL and tryglicerids

Study contacts

Contact information is provided by the study sponsor or research team.

Julieta Maria Mendez Romero

CONTACT

[email protected]

0985300046

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Caaguazu

Other

Collaborators

  • Hospital Nacional de Itaugua, MSPyBS, Paraguay)
  • Instituto Nacional de Salud, Paraguay
  • McMaster University
  • Universidad de La Frontera
  • Universidad del Cauca

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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