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

NCT ID: NCT06896175

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lipid Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
They will not distinguished if the yerba is the harvested before or after the safra period

Study Groups

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YM mate

Yerba consumption of mate only

Group Type ACTIVE_COMPARATOR

Yerba mate consumption (Ilex paraguayensis) A

Intervention Type DIETARY_SUPPLEMENT

Yerba mate of the begining of the harvest time

Yerba mate comsuption (ilex paraguayencis) B

Intervention Type DIETARY_SUPPLEMENT

Yerba mate of the final time of the harvest

YM terere

Yerba mate terere consumption only

Group Type ACTIVE_COMPARATOR

Yerba mate consumption (Ilex paraguayensis) A

Intervention Type DIETARY_SUPPLEMENT

Yerba mate of the begining of the harvest time

Yerba mate comsuption (ilex paraguayencis) B

Intervention Type DIETARY_SUPPLEMENT

Yerba mate of the final time of the harvest

YM mate and terere

Yerba mate consuptiom as mate and terere

Group Type EXPERIMENTAL

Yerba mate consumption (Ilex paraguayensis) A

Intervention Type DIETARY_SUPPLEMENT

Yerba mate of the begining of the harvest time

Yerba mate comsuption (ilex paraguayencis) B

Intervention Type DIETARY_SUPPLEMENT

Yerba mate of the final time of the harvest

Interventions

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Yerba mate consumption (Ilex paraguayensis) A

Yerba mate of the begining of the harvest time

Intervention Type DIETARY_SUPPLEMENT

Yerba mate comsuption (ilex paraguayencis) B

Yerba mate of the final time of the harvest

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Nacional de Itaugua, MSPyBS, Paraguay)

UNKNOWN

Sponsor Role collaborator

Instituto Nacional de Salud, Paraguay

OTHER

Sponsor Role collaborator

Universidad de La Frontera

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Universidad del Cauca

OTHER

Sponsor Role collaborator

Universidad Nacional de Caaguazu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guiomar Viveros

Role: STUDY_CHAIR

Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

Gloria Gonzalez

Role: STUDY_DIRECTOR

Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

Angel Rolon

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud

Central Contacts

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Julieta Maria Mendez Romero

Role: CONTACT

0985300046

Other Identifiers

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PINV01-1074

Identifier Type: -

Identifier Source: org_study_id

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