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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lipid Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Yerba mate consumption (Ilex paraguayensis) A; Dietary supplement: Yerba mate comsuption (ilex paraguayencis) B

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julieta Maria Mendez Romero; Phone Number: 0985300046; Email: julietamendez@unca.edu.py

Study Locations

• Paraguay
  • Coronel Oviedo, Paraguay
    • Recruiting
    • UNCA
    • Contact: Gloria Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Individuals of both sexes, between 18 and 60 years of age, residing in the country, who consume prepared yerba mate.
2. 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.
3. Two weeks of abstinence from consuming prepared yerba mate, either as mate or tereré, prior to randomization for the trial.
4. 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.
5. Do not change the yerba mate consumer's usual diet or regular physical activity during the trial period.
6. Agree to know the laboratory results of the lipid profile only at the end of the trial (180 days after the start).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: YM mate; Yerba consumption of mate only	Dietary supplement: Yerba mate consumption (Ilex paraguayensis) A; Yerba mate of the begining of the harvest time; Dietary supplement: Yerba mate comsuption (ilex paraguayencis) B; Yerba mate of the final time of the harvest
Active Comparator: YM terere; Yerba mate terere consumption only	Dietary supplement: Yerba mate consumption (Ilex paraguayensis) A; Yerba mate of the begining of the harvest time; Dietary supplement: Yerba mate comsuption (ilex paraguayencis) B; Yerba mate of the final time of the harvest
Experimental: YM mate and terere; Yerba mate consuptiom as mate and terere	Dietary supplement: Yerba mate consumption (Ilex paraguayensis) A; Yerba mate of the begining of the harvest time; Dietary supplement: Yerba mate comsuption (ilex paraguayencis) B; Yerba mate of the final time of the harvest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on lipid profile	Effect of total cholesterol, LDL, HDL and tryglicerids	six months

Collaborators and Investigators

• Sponsor: Universidad Nacional de Caaguazu
• Collaborators: McMaster University; Universidad de La Frontera; Universidad del Cauca; Hospital Nacional de Itaugua, MSPyBS, Paraguay); Instituto Nacional de Salud, Paraguay
• Investigators: Study Chair: Guiomar Viveros, Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud; Study Director: Gloria Gonzalez, Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud; Principal Investigator: Angel Rolon, Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: PINV01-1074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It could be shared with anonimous data for the participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No