Metabolic SyndromeNCT07000825
EFFECTS OF A YERBA MATE EXTRACT IN REDUCING METABOLIC SYNDROME IN OVERWEIGHT INDIVIDUALS
A study of Metabolic Syndrome and Diabetes, run by Universidade Federal da Fronteira Sul at 1 site in Brazil.
Trial summary
Yerba mate (Ilex paraguariensis), a traditional drink consumed in different parts of the word, but especially in southern Brazil, is an importante source of polyphenols and has a high antioxidant potencial, With a moderate content of methylxanthines, yerba mate has stood out for its promising effects in modulating… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Diabetes, Oxidative Stress
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Oct 2025to 1 Dec 2029
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women;
- aged between 40 and 65 years;
- with no previous cardiovascular history;
- individuals who are non-smokers or who have stopped smoking in the last 3 years;
- individuals who agree to maintain a habitual diet and physical activity;
- individuals who agree to maintain habitual consumption of polyphenol-rich beverages (yerba mate, teas, coffee, wine, cocoa, soy milk and fruit juice) during the course of the study;
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- individuals who are not taking hypoglycemic, antihypertensive or anticholesterolemic drugs and;
- individuals who are overweight or obese (BMI≥25 to 34 Kg/m2 );
- individuals who have given up nutritional monitoring at least 3 months or who are undergoing nutritional treatment, but who are not showing weight changes of >5% in the last 3 months.
Who cannot join
- diagnosis uncontrolled metabolic or endocrine pathologies;
- who have undergone obesity surgery;
- post-menopausal women;
- pregnant and breastfeeding women;
- use of antipsychotics;
- with a vegetarian or vegan diet;
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- who use probiotics and food supplements with antioxidant characteristics;
- those who have had a weight change of more than 10% in the last 3 months; 9) in treatment for excess body weight (hypocaloric diet or current nutritional treatment);
- 10) smokers or chronic alcoholics; 11) Severe hypertension, history of cardiovascular disease with clinical complications such as: acute myocardial infarction and other coronary heart disease; 12) individuals with known malignant neoplasms, gastrointestinal diseases, kidney disease and/or liver 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: EFFECTS OF INGESTING AN EXTRACT OR YERBA MATE (ILEX PARAGUARIENSIS) ON NUTRICIONAL, METABOLIC AND INFLAMMATORY PARAMETERS AND OXIDATIVE STATUS IN OVERWEIGHT INDIVIDUALS
Yerba mate (Ilex paraguariensis), a traditional drink consumed in different parts of the word, but especially in southern Brazil, is an importante source of polyphenols and has a high antioxidant potencial, With a moderate content of methylxanthines, yerba mate has stood out for its promising effects in modulating metabolic pathways in pre-clinical models. However, its beneficial effets in clinical trials have yet to be elucidated. Overweight and chronic non-communicable diases are urgent public health conditions and reducing the risk of these conditions through food sources is one of the most sustainable approaches. This study aims to evaluate the impact of a standardized extract of yerba mate on nutritional, biochemical, metabolic, inflammatory and antioxidant status parameters in overweight individuals compared to a placebo. A double-blind, parallel, randomized, placebo- controlled clinical trial will be conducted involving 80 overweight individuals. The subjects will receive an encapsulated yerba mate extract totaling 2,250 mg or a corresponding placebo, fractionated three times a day. This amount was defined according to previous studies thet estimated the habitual intake of yerba mate in the form of chimarrão or tererê by adults in a city in the southern region of the country. Anthropometric measurements, composition, blood pressure and blod and stool samples will be collected for nutritional assessment, metabolic and inflammatory parameters and antioxidant status assessment on days 0 and 90. The data will be analyzed descriptively and inferentially. Differences in the individuals characteristics at baseline and comparisons between groups will be aseessed using the difference of means test (depending on the normality of the data) and chi-square or Fisher-s exact test for categorical variabes, In addition, to compare the effect of the intervention between the groups, a two-way analysis of covariance will be used. A 5% significance level will be adopted. It is expect to find positive effects of yerba mate extract on the parameters assessed.
- Conditions
- Metabolic Syndrome, Diabetes, Oxidative Stress, Dyslipidemia, Inflamation
- Being tested
- Intervention with yerba mate extract or placebo
- Keywords
- glycemic control, lipid metabolism, oxidative stress, metabolic syndrome, adipose tissue
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with yerba mate extract or placeboDietary supplement
The standardized extract of yerba mate (Ilex paraguariensis) will be supplied by Sustentec. It is a dry extract of the plant's green, powdered leaves, obtained through aqueous extraction. The extract was obtained by infusing the dried leaves of the plant and the drying process was carried out using a spray-dryer (ratio 6/1 leaves/extract). The extract will be encapsulated containing 250 mg each. Administration Intervention group: 2,250 mg of standardized yerba mate extract will be administered in 9 capsules, 3 times a day, just before the main meals. This amount will provide approximately 980 mg of caffeoylquinic acids/day, which was defined based on the estimated usual intake of caffeoylquinic acids by individuals in a municipality in the southern region of the country, from traditional drinks made with yerba mate (chimarrão and tereré) (Gebara et al., 2017). Placebo group: 9 capsules containing maltodextrin will be administered 3 times a day, just before the main meals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (yerba mate) | Experimental | 2,250 mg of standardized yerba mate extract will be administered in 9 capsules, 3 times a day, just before the main meals. Receives: Dietary Supplement: Intervention with yerba mate extract or placebo |
| Test (yerba mate) | Placebo comparator | 9 capsules containing maltodextrin will be administered 3 times a day, just before the main meals. Receives: Dietary Supplement: Intervention with yerba mate extract or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
measured by weight in kilograms and height in meters
Measured: 12 weeks
fat percentage
measured by electrical bioimpedance
Measured: 12 weeks
diabetes
measured by plasma glucose, fructosamine and C peptide
Measured: 12 weeks
abdominal fat
measured by waist circumference
Measured: 12 weeks
dyslipidemia
measured by lipid profile
Measured: 12 weeks
diabetes
measured by insulin levels
Measured: 12 weeks
Secondary outcomes (8)
inflamation
measured by cytokine levels and C reative-protein
Measured: 12 weeks
oxidative stress
measured by lipid peroxidation
Measured: 12 weeks
oxidative stress
measured by plasma thio levels
Measured: 12 weeks
oxidative stress
measured by total antioxidant capacity of plasma
Measured: 12 weeks
transcriptome
measured by gene expression
Measured: 12 weeks
gut microbiota
measured by microbiome DNA
Measured: 12 weeks
Iron metabolism
measured by ferritin, seric iron, transferrin, iron-binding capacity, and hepcidin
Measured: 12 weeks
metabolism
Mensured by hepatic enzymes, uric acid, creatinin and bilirubin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start6 Oct 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- This is a randomized, double-blind, parallel-group clinical trial with a 90-day intervention. The trial will be registered with the Brazilian Clinical Trial Registry - Ministry of Health (https://ensaiosclinicos.gov.br/) and will be conducted in accordance with the CONSORT guidelines (Schulz KF, Altman DG, Moher D, for CONSORT Group. CONSORT Statement 2010: updated guidelines for reporting parallel-group randomized trials). The clinical trial will be conducted from March 2025 to July 2026.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal da Fronteira Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Itaipu Technological Park (ITP), Fundação Araucária
- Responsible party
- Principal investigator, Eloá Angélica Koehnlein, Universidade Federal da Fronteira Sul
- Investigators
- Eloá A Koehnlein, Doctorate, Principal investigator, Universidade Federal da Fronteira Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000825
- Sponsor's protocol ID
- 84742724.6.0000.5564
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF INGESTING AN EXTRACT OR YERBA MATE (ILEX PARAGUARIENSIS) ON NUTRICIONAL, METABOLIC AND INFLAMMATORY PARAMETERS AND OXIDATIVE STATUS IN OVERWEIGHT INDIVIDUALS
- ClinicalTrials.gov ID
- NCT07000825
- Acronym / sponsor ID
- 84742724.6.0000.5564
- Conditions
- Metabolic Syndrome, Diabetes, Oxidative Stress, Dyslipidemia, Inflamation
- Keywords
- glycemic control, lipid metabolism, oxidative stress, metabolic syndrome, adipose tissue
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal da Fronteira SulUniversity, hospital or other
- Collaborators
- Itaipu Technological Park (ITP), Fundação Araucária
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 3 Jun 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.
Yerba mate (Ilex paraguariensis), a traditional drink consumed in different parts of the word, but especially in southern Brazil, is an importante source of polyphenols and has a high antioxidant potencial, With a moderate content of methylxanthines, yerba mate has stood out for its promising effects in modulating metabolic pathways in pre-clinical models. However, its beneficial effets in clinical trials have yet to be elucidated. Overweight and chronic non-communicable diases are urgent public health conditions and reducing the risk of these conditions through food sources is one of the most sustainable approaches. This study aims to evaluate the impact of a standardized extract of yerba mate on nutritional, biochemical, metabolic, inflammatory and antioxidant status parameters in overweight individuals compared to a placebo. A double-blind, parallel, randomized, placebo- controlled clinical trial will be conducted involving 80 overweight individuals. The subjects will receive an encapsulated yerba mate extract totaling 2,250 mg or a corresponding placebo, fractionated three times a day. This amount was defined according to previous studies thet estimated the habitual intake of yerba mate in the form of chimarrão or tererê by adults in a city in the southern region of the country. Anthropometric measurements, composition, blood pressure and blod and stool samples will be collected for nutritional assessment, metabolic and inflammatory parameters and antioxidant status assessment on days 0 and 90. The data will be analyzed descriptively and inferentially. Differences in the individuals characteristics at baseline and comparisons between groups will be aseessed using the difference of means test (depending on the normality of the data) and chi-square or Fisher-s exact test for categorical variabes, In addition, to compare the effect of the intervention between the groups, a two-way analysis of covariance will be used. A 5% significance level will be adopted. It is expect to find positive effects of yerba mate extract on the parameters assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, parallel-group clinical trial with a 90-day intervention. The trial will be registered with the Brazilian Clinical Trial Registry - Ministry of Health (https://ensaiosclinicos.gov.br/) and will be conducted in accordance with the CONSORT guidelines (Schulz KF, Altman DG, Moher D, for CONSORT Group. CONSORT Statement 2010: updated guidelines for reporting parallel-group randomized trials). The clinical trial will be conducted from March 2025 to July 2026.
| Arm | Type | Receives |
|---|---|---|
| Intervention (yerba mate) | Experimental | Dietary Supplement: Intervention with yerba mate extract or placebo2,250 mg of standardized yerba mate extract will be administered in 9 capsules, 3 times a day, just before the main meals. |
| Test (yerba mate) | Placebo comparator | Dietary Supplement: Intervention with yerba mate extract or placebo9 capsules containing maltodextrin will be administered 3 times a day, just before the main meals. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- men and women;
- aged between 40 and 65 years;
- with no previous cardiovascular history;
- individuals who are non-smokers or who have stopped smoking in the last 3 years;
- individuals who agree to maintain a habitual diet and physical activity;
Key exclusion criteria (9 listed)
- diagnosis uncontrolled metabolic or endocrine pathologies;
- who have undergone obesity surgery;
- post-menopausal women;
- pregnant and breastfeeding women;
- use of antipsychotics;
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 |
|---|---|---|
| Intervention with yerba mate extract or placeboThe standardized extract of yerba mate (Ilex paraguariensis) will be supplied by Sustentec. It is a dry extract of the plant's green, powdered leaves, obtained through aqueous extraction. The extract was obtained by infusing the dried leaves of the plant and the drying process was carried out using a spray-dryer (ratio 6/1 leaves/extract). The extract will be encapsulated containing 250 mg each. Administration Intervention group: 2,250 mg of standardized yerba mate extract will be administered in 9 capsules, 3 times a day, just before the main meals. This amount will provide approximately 980 mg of caffeoylquinic acids/day, which was defined based on the estimated usual intake of caffeoylquinic acids by individuals in a municipality in the southern region of the country, from traditional drinks made with yerba mate (chimarrão and tereré) (Gebara et al., 2017). Placebo group: 9 capsules containing maltodextrin will be administered 3 times a day, just before the main meals. | Dietary supplement | Intervention (yerba mate), Test (yerba mate) |
Primary outcome
body mass index
Time frame: 12 weeks
measured by weight in kilograms and height in meters
fat percentage
Time frame: 12 weeks
measured by electrical bioimpedance
diabetes
Time frame: 12 weeks
measured by plasma glucose, fructosamine and C peptide
abdominal fat
Time frame: 12 weeks
measured by waist circumference
dyslipidemia
Time frame: 12 weeks
measured by lipid profile
diabetes
Time frame: 12 weeks
measured by insulin levels
8 secondary outcomes
inflamation
Time frame: 12 weeks
oxidative stress
Time frame: 12 weeks
oxidative stress
Time frame: 12 weeks
oxidative stress
Time frame: 12 weeks
transcriptome
Time frame: 12 weeks
gut microbiota
Time frame: 12 weeks
Iron metabolism
Time frame: 12 weeks
metabolism
Time frame: 12 weeks
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 29 May 2026.
- 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.
Eloá A Koehnlein, Doctorate principal investigator
Universidade Federal da Fronteira Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Metabolic Syndrome and Diabetes, run by Universidade Federal da Fronteira Sul at 1 site in Brazil.
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 9 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 29 May 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
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?
body mass index (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 29 May 2026.