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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversidad Nacional de Caaguazu

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Yerba mate consumption (Ilex paraguayensis) A
  • Yerba mate comsuption (ilex paraguayencis) B

Treatment groups

198 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Universidad Nacional de Caaguazu

Lead sponsor

Hospital Nacional de Itaugua, MSPyBS, Paraguay)

Collaborator

Instituto Nacional de Salud, Paraguay

Collaborator

Universidad de La Frontera

Collaborator

McMaster University

Collaborator

Universidad del Cauca

Collaborator