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RecruitingNCT06896175Updated Apr 16, 2026

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

An interventional study of Yerba mate consumption (Ilex paraguayensis) A and Yerba mate comsuption (ilex paraguayencis) B in Lipid Metabolism Disorders, sponsored by Universidad Nacional de Caaguazu. Recruiting at 1 site in Paraguay. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Universidad Nacional de Caaguazu · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lipid Metabolism Disorders
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
198 participants (estimated)

Study arms

  • Active comparator
    YM mate

    Yerba consumption of mate only

    Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A · Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) B

  • Active comparator
    YM terere

    Yerba mate terere consumption only

    Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A · Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) B

  • Experimental
    YM mate and terere

    Yerba mate consuptiom as mate and terere

    Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A · Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) B

Interventions

  • Dietary supplementYerba mate consumption (Ilex paraguayensis) A

    Yerba mate of the begining of the harvest time

  • Dietary supplementYerba mate comsuption (ilex paraguayencis) B

    Yerba mate of the final time of the harvest

05

What researchers measure

Primary outcomes

  1. Effect on lipid profile

    Effect of total cholesterol, LDL, HDL and tryglicerids

    Time frame: six months

06

Study locations

1 of 1 sites recruiting
  • UNCA
    Coronel Oviedo, Paraguay
    • Gloria Gonzalez · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — It could be shared with anonimous data for the participants

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06896175
Lead sponsor
Universidad Nacional de Caaguazu
Collaborators
Hospital Nacional de Itaugua, MSPyBS, Paraguay), Instituto Nacional de Salud, Paraguay, Universidad de La Frontera, McMaster University, Universidad del Cauca
Responsible party
Sponsor
First posted
Mar 26, 2025
Start date
Feb 1, 2026
Primary completion
Aug 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Apr 16, 2026

Study contacts

Julieta Maria Mendez Romero
Contact
julietamendez@unca.edu.py
0985300046
Guiomar Viveros
study chair · Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud
Gloria Gonzalez
study director · Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud
Angel Rolon
principal investigator · Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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