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

NCT06896175 | Recruiting

• 1 other identifier: PINV01-1074
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipid Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• Effect on lipid profile

  Effect of total cholesterol, LDL, HDL and tryglicerids

  six months

Study Arms (3)

YM mate

ACTIVE COMPARATOR

Yerba consumption of mate only

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

YM terere

ACTIVE COMPARATOR

Yerba mate terere consumption only

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

YM mate and terere

EXPERIMENTAL

Yerba mate consuptiom as mate and terere

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

Interventions

Yerba mate consumption (Ilex paraguayensis) A DIETARY_SUPPLEMENT

Yerba mate of the begining of the harvest time

YM mate; YM mate and terere; YM terere

Yerba mate comsuption (ilex paraguayencis) B DIETARY_SUPPLEMENT

Yerba mate of the final time of the harvest

YM mate; YM mate and terere; YM terere

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Caaguazu: lead
• 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

Study Sites (1)

UNCA

Coronel Oviedo, Paraguay

RECRUITING

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Guiomar Viveros

  Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

  STUDY CHAIR

• Gloria Gonzalez

  Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

  STUDY DIRECTOR

• Angel Rolon

  Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julieta Maria Mendez Romero

CONTACT

0985300046; julietamendez@unca.edu.py

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: They will not distinguished if the yerba is the harvested before or after the safra period
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First, they will be divided into two groups: YMA (Yerba harvested at the beginning of the safra) and YMB (Yerba harvested at the end of the safra). Both groups are then divided into three strata: consumption of mate only, consumption of terere only, consumption of both mate and terere.

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

PA (1)