Cardiovascular RiskINFU-SALUDNCT06729905
Study of the Effects of Yerba Mate on Cardiometabolic Health
A study testing Yerba mate tea in people with Cardiovascular Risk and Hypercholerolemia, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. It will also learn about the effects of this beverage, widely consumed in South America, on other cardiometabolic biomarkers like blood glucose… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk, Hypercholerolemia
- What is being tested?
- Yerba mate tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2012to 30 May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 20-25 kg/m2
- Total cholesterol < 200 mg/dL for healthy participants, between 200-240 mg/dL for participants at cardiovascular risk, or
- LDL cholesterol < 130 mg/dL for healthy participants, between 130-159 mg/dL for participants at cardiovascular risk.
Who cannot join
- Smoking
- Pregnant/lactating women
- Vegetarians/vegans
- Consumption of vitamins or dietary supplements
- Suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia
- On prescription drugs (statins) or on antibiotics 6 months before the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Madrid, 28040
About this study
The goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. It will also learn about the effects of this beverage, widely consumed in South America, on other cardiometabolic biomarkers like blood glucose levels, inflammation, or weight control. The main questions it aims to answer are:
Does daily consumption of a yerba mate tea reduce the blood lipid levels in hypercholesterolemic persons? May healthy persons also benefit from the consumption of yerba mate tea?
Read more
Researchers will compare yerba mate to a control drink (isotonic drink or water, free of polyphenols and caffeine) to see if yerba mate tea helps to reduce blood cholesterol in hypercholesterolemic persons.
Participants will:
Drink 3 cups of yerba mate tea or an isotonic drink every day for 2 months, then change to the other drink during another 2 months.
Visit the clinic at the beginning and end of each 2-month period for checkups and tests Refraing from consuming coffee and some foods during the study. Complete a dietary questionnaire during 3 days before each visit to the clinic.
Read the detailed description
This is a randomized, crossover, control study in healthy and hypercholesterolemic free-living to assess the effect of yerba mate on different outcomes related to cardiovascular health.
After a 2-week run-in period, participants will be randomly allocated to the first 8-weeks intervention with yerba mate or the control drink. After a 3-week wash-out, they will change to consume during 8 weeks the other drink.
A nurse will collect a fasting blood sample at the beginning and end of each intervention stage. Blood pressure and anthropometric parameters will be measured. A 72-h dietary record will be completed by participants before each visit to the Human Nutrition Unit (HNU) at the Institute of Food Science, Technology and Nutrition (ICTAN-CSIC).
During the study, participants will refrain from consuming coffee, cocoa, tea, and caffeine-containing drinks. Other foods rich in certain polyphenols (i.e. hydroxycinnamic acids) will also be restricted.
Blood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the Outcomes section.
- Conditions
- Cardiovascular Risk, Hypercholerolemia
- Being tested
- Yerba mate tea, Control drink
- Keywords
- Yerba mate, Cardiovascular health, Inflammation, Blood lipids, Glucose homeostasis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yerba mate teaDietary supplement
Consumption of three cups per day of a beverage prepared with yerba mate
Control drinkDietary supplement
Consumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee.
| Study group | Role | What they receive |
|---|---|---|
| Yerba mate | Experimental | Consumption of three cups of a yerba mate tea per day Receives: Dietary Supplement: Yerba mate tea |
| Control | Other | Consuming water or an isotonic drink, free of polyphenols or caffeine. Receives: Dietary Supplement: Control drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipids
Change in blood levels of total cholesterol or LDL-cholesterol or VLDL-cholesterol or HDL-cholesterol or triglycerides or phospholipids at the end of the intervention with yerba mate
Measured: From enrollment to the end of each treatment at 8 weeks
Secondary outcomes (10)
Blood pressure
Changes in blood pressure at the end of the intervention with yerba mate.
Measured: From enrollment to the end of each treatment at 8 weeks
Inflammatory cytokines
Change in the levels of C-reactive protein (CRP), or pro-inflammatory cytokines (tumor necrosis factor-alpha (TNF-a), or interferon gamma (IFN-g), interleukin (IL)-1beta (IL-1b), or IL-2, or IL-5, or IL-6, or IL-7, or IL-8, or IL-12 or IL-13)) or anti-inflammatory cytokines IL-4 or IL-10 at the end of the intervention with yerba mate
Measured: From enrollment to the end of each treatment at 8 weeks
Fasting blood glucose
Change of fasting blood glucose levels at the end of the intervention with yerba mate
Measured: From enrollment to the end of each treatment at 8 weeks
Fasting blood insulin
Change of fasting insulin levels at the end of intervention with yerba mate
Measured: From enrollment to the end of each treatment at 8 weeks
Insulin resistance
Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) at the end of intervention with yerba mate
Measured: From enrollment to the end of each treatment at 8 weeks
Insulin sensitivity
Change in quantitative insulin levels sensitivity check index (QUICKI) at the end of the intervention with yerba mate. Higher score in QUICKI means a better outcome compared to initial values.
Measured: From enrollment to the end of each treatment at 8 weeks
Hormones, incretins and adipokines levels
Changes in serum levels of C peptide or glucagon or glucagon inhibitory peptide (GIP) or glucagon-like peptide type 1 (GLP-1) or ghrelin or leptin or resistin or plasminogen activator inhibitor type 1 (PAI-1) or visfatin at the end of the intervention with yerba mate.
Measured: From enrollment to the end of each treatment at 8 weeks
Cytokines, chemokines and cell-adherence molecules levels
Changes in serum levels of granulocyte (G-CSF) or granulocyte/macrophague (GM-CSF) colony-stimulating factors, or monocyte-chemoattractant protein-1 (MCP-1) or macrophage inflammatory protein-1beta (MIP-1b) or vascular (VCAM-1) or intracellular (ICAM-1) adhesion molecules at the end of the intervention with yerba mate.
Measured: From enrollment to the end of each treatment at 8 weeks
Liver function
No changes in serum levels of alanin transferase (ALAT), or aspartate transferase (ASAT) at the end of the intervention with yerba mate.
Measured: From enrollment to the end of each treatment at 8 weeks
Anthropometry
Changes in body weight or body fat percentage or body circunferences (wais, or hip, or thigh, or brachial) or skinfolds (tricipital or subscapular) at the end of the intervention with yerba mate.
Measured: From enrollment to the end of each treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Jan 2012
- Primary completion30 Jul 2013
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Sponsor
- Investigators
- Laura Bravo, Professor, Principal investigator, ICTAN-CSIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729905
- Sponsor's protocol ID
- AGL2010-18269
- Acronym
- INFU-SALUD
- Status last verified
- May 2025
- First submitted
- 7 Dec 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bravo L, Martinez-Lopez S, Sierra-Cinos JL, Mateos R, Sarria B. Yerba Mate (Ilex paraguariensis St. Hill.) Tea May Have Cardiometabolic Beneficial Effects in Healthy and At-Risk Subjects: A Randomized, Controlled, Blind, Crossover Trial in Nonhabitual Consumers. Mol Nutr Food Res. 2025 Aug;69(15):e70065. doi: 10.1002/mnfr.70065. Epub 2025 Apr 22.
PubMed 40263915
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Yerba Mate on Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT06729905
- Acronym / sponsor ID
- INFU-SALUD / AGL2010-18269
- Conditions
- Cardiovascular Risk, Hypercholerolemia
- Keywords
- Yerba mate, Cardiovascular health, Inflammation, Blood lipids, Glucose homeostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 10 Jan 2012 (actual)
- Primary completion
- 30 Jul 2013 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 12 Dec 2024 (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.
The goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. It will also learn about the effects of this beverage, widely consumed in South America, on other cardiometabolic biomarkers like blood glucose levels, inflammation, or weight control. The main questions it aims to answer are:
Does daily consumption of a yerba mate tea reduce the blood lipid levels in hypercholesterolemic persons? May healthy persons also benefit from the consumption of yerba mate tea?
Researchers will compare yerba mate to a control drink (isotonic drink or water, free of polyphenols and caffeine) to see if yerba mate tea helps to reduce blood cholesterol in hypercholesterolemic persons.
Participants will:
Drink 3 cups of yerba mate tea or an isotonic drink every day for 2 months, then change to the other drink during another 2 months.
Visit the clinic at the beginning and end of each 2-month period for checkups and tests Refraing from consuming coffee and some foods during the study. Complete a dietary questionnaire during 3 days before each visit to the clinic.
Detailed description
This is a randomized, crossover, control study in healthy and hypercholesterolemic free-living to assess the effect of yerba mate on different outcomes related to cardiovascular health.
After a 2-week run-in period, participants will be randomly allocated to the first 8-weeks intervention with yerba mate or the control drink. After a 3-week wash-out, they will change to consume during 8 weeks the other drink.
A nurse will collect a fasting blood sample at the beginning and end of each intervention stage. Blood pressure and anthropometric parameters will be measured. A 72-h dietary record will be completed by participants before each visit to the Human Nutrition Unit (HNU) at the Institute of Food Science, Technology and Nutrition (ICTAN-CSIC).
During the study, participants will refrain from consuming coffee, cocoa, tea, and caffeine-containing drinks. Other foods rich in certain polyphenols (i.e. hydroxycinnamic acids) will also be restricted.
Blood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the Outcomes section.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yerba mate | Experimental | Dietary Supplement: Yerba mate teaConsumption of three cups of a yerba mate tea per day |
| Control | Other | Dietary Supplement: Control drinkConsuming water or an isotonic drink, free of polyphenols or caffeine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index between 20-25 kg/m2
- Total cholesterol < 200 mg/dL for healthy participants, between 200-240 mg/dL for participants at cardiovascular risk, or
- LDL cholesterol < 130 mg/dL for healthy participants, between 130-159 mg/dL for participants at cardiovascular risk.
Key exclusion criteria (6 listed)
- Smoking
- Pregnant/lactating women
- Vegetarians/vegans
- Consumption of vitamins or dietary supplements
- Suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia
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 teaConsumption of three cups per day of a beverage prepared with yerba mate | Dietary supplement | Yerba mate |
| Control drinkConsumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee. | Dietary supplement | Control |
Primary outcome
Blood lipids
Time frame: From enrollment to the end of each treatment at 8 weeks
Change in blood levels of total cholesterol or LDL-cholesterol or VLDL-cholesterol or HDL-cholesterol or triglycerides or phospholipids at the end of the intervention with yerba mate
10 secondary outcomes
Blood pressure
Time frame: From enrollment to the end of each treatment at 8 weeks
Inflammatory cytokines
Time frame: From enrollment to the end of each treatment at 8 weeks
Fasting blood glucose
Time frame: From enrollment to the end of each treatment at 8 weeks
Fasting blood insulin
Time frame: From enrollment to the end of each treatment at 8 weeks
Insulin resistance
Time frame: From enrollment to the end of each treatment at 8 weeks
Insulin sensitivity
Time frame: From enrollment to the end of each treatment at 8 weeks
Hormones, incretins and adipokines levels
Time frame: From enrollment to the end of each treatment at 8 weeks
Cytokines, chemokines and cell-adherence molecules levels
Time frame: From enrollment to the end of each treatment at 8 weeks
Liver function
Time frame: From enrollment to the end of each treatment at 8 weeks
Anthropometry
Time frame: From enrollment to the end of each treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 40263915Bravo L, Martinez-Lopez S, Sierra-Cinos JL, Mateos R, Sarria B. Yerba Mate (Ilex paraguariensis St. Hill.) Tea May Have Cardiometabolic Beneficial Effects in Healthy and At-Risk Subjects: A Randomized, Controlled, Blind, Crossover Trial in Nonhabitual Consumers. Mol Nutr Food Res. 2025 Aug;69(15):e70065. doi: 10.1002/mnfr.70065. Epub 2025 Apr 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Laura Bravo, Professor principal investigator
ICTAN-CSIC
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 tea in people with Cardiovascular Risk and Hypercholerolemia, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lipids (time frame: From enrollment to the end of each treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06729905, which also lists 1 linked publication.
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 22 May 2025.