Lipid Metabolism DisordersNCT06896175
Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile
A study testing Yerba mate consumption (Ilex paraguayensis) A and Yerba mate comsuption (ilex paraguayencis) B in people with Lipid Metabolism Disorders, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- Yerba mate consumption (Ilex paraguayensis) A and Yerba mate comsuption (ilex paraguayencis) B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteParaguay
- Study dates
- 1 Feb 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- Yerba mate consumption (Ilex paraguayensis) A, Yerba mate comsuption (ilex paraguayencis) B
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yerba mate consumption (Ilex paraguayensis) ADietary supplement
Yerba mate of the begining of the harvest time
Yerba mate comsuption (ilex paraguayencis) BDietary supplement
Yerba mate of the final time of the harvest
| Study group | Role | What they receive |
|---|---|---|
| YM mate | Active comparator | Yerba consumption of mate only Receives: 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 Receives: 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 Receives: Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A; Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on lipid profile
Effect of total cholesterol, LDL, HDL and tryglicerids
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Caaguazu
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Itaugua, MSPyBS, Paraguay), Instituto Nacional de Salud, Paraguay, Universidad de La Frontera, McMaster University, Universidad del Cauca
- Responsible party
- Sponsor
- Investigators
- Guiomar Viveros, Study chair, Universidad Nacional de Caaguazu, Facultad de Ciencias de la SaludGloria Gonzalez, Study director, Universidad Nacional de Caaguazu, Facultad de Ciencias de la SaludAngel Rolon, Principal investigator, Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896175
- Sponsor's protocol ID
- PINV01-1074
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It could be shared with anonimous data for the participants
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06896175
- Acronym / sponsor ID
- PINV01-1074
- Conditions
- Lipid Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Universidad Nacional de CaaguazuUniversity, hospital or other
- Collaborators
- Hospital Nacional de Itaugua, MSPyBS, Paraguay), Instituto Nacional de Salud, Paraguay, Universidad de La Frontera, McMaster University, Universidad del Cauca
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| YM mate | Active comparator | Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A, Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) BYerba consumption of mate only |
| YM terere | Active comparator | Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A, Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) BYerba mate terere consumption only |
| YM mate and terere | Experimental | Dietary Supplement: Yerba mate consumption (Ilex paraguayensis) A, Dietary Supplement: Yerba mate comsuption (ilex paraguayencis) BYerba mate consuptiom as mate and terere |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yerba mate consumption (Ilex paraguayensis) AYerba mate of the begining of the harvest time | Dietary supplement | YM mate, YM mate and terere, YM terere |
| Yerba mate comsuption (ilex paraguayencis) BYerba mate of the final time of the harvest | Dietary supplement | YM mate, YM mate and terere, YM terere |
Primary outcome
Effect on lipid profile
Time frame: six months
Effect of total cholesterol, LDL, HDL and tryglicerids
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided. It could be shared with anonimous data for the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yerba mate consumption (Ilex paraguayensis) A and Yerba mate comsuption (ilex paraguayencis) B in people with Lipid Metabolism Disorders, run by Universidad Nacional de Caaguazu at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julieta Maria Mendez Romero (0985300046, julietamendez@unca.edu.py), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on lipid profile (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.