Cardiovascular DiseaseYMCH-2015NCT02789722
Yerba Mate (Ilex Paraguariensis A.St.-Hil.): Assessment of Cardiovascular Health
A study testing Yerba Mate Extract in people with Cardiovascular Disease and Diabetes, run by Karimi Sater Gebara at 1 site in Brazil.
Trial summary
Mate or yerba-mate (Ilex paraguariensis A.St.-Hil.) is a native plant from South America highly consumed in this region. Different traditional products (mate, mate tea, chimarrao, tereré) are obtained from the yerba-mate leaves and consumed as herbal tea. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Diabetes
- What is being tested?
- Yerba Mate Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2016to May 2018
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No smoking, or having stopped smoking for more than three years;
- Having no more than one of the five criteria associated with metabolic syndrome proposed by the National Cholesterol Education Program's Adult Treatment Panel III (NCEP-ATP III) and approved by Brazilian scientific societies in the First Brazilian Guideline for Diagnosis and Treatment of Metabolic Syndrome (2005);
- Not consuming multivitamin supplements, antioxidants or polyphenols rich products in the last 3 months before the study;
- Accepting reduced consumption of natural polyphenols rich beverages (yerba mate, tea, coffee, wine, cocoa, soy milk, fruit juices) during the study;
- Not using any antihypertensive or anticholesterolemic drugs;
- Accepting to participate in the study after signing the Informed Consent and completing the information document.
Who cannot join
- Being diagnosed with diabetes, mental illness or other severe conditions that may influence the results of the study;
- Chronic alcoholism;
- Having severe hypertension with clinical complications such as acute myocardial infarction and other coronary artery diseases;
- Having kidney or liver diseases;
- Not accepting to participate in the study refusing to sign the Informed Consent, in accordance with the fundamental ethical and scientific requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Yerba Mate (Ilex Paraguariensis A.St.-Hil.) Products on the Promotion of Health: Assessment of Cardiovascular Health
Mate or yerba-mate (Ilex paraguariensis A.St.-Hil.) is a native plant from South America highly consumed in this region. Different traditional products (mate, mate tea, chimarrao, tereré) are obtained from the yerba-mate leaves and consumed as herbal tea. Mate is a rich source of bioactive phenolic compounds, mainly caffeoylquinic acids. The richness of different mono- and dicaffeoylquinic acids is a peculiarity of mate derived products. However, in contrast to other plant-based beverages rich in polyphenols like tea or coffee, the research and the industry have yet little explored the potential interest of mate product to promote human health. There has been a growing interest to the development of healthier foods to face the burden of cardiovascular diseases (CVD), especially those naturally rich in bioactive phenolic compounds with protective effects against the development of chronic diseases. Different in vitro and animals studies associate the mate consumption with cardiovascular protection mechanisms. Consistent information about this activity and the long-term consumption effects in humans are scarce. The aim of this study is to assess through a randomized controlled trial the impact of chronic intake of mate on intermediate biomarkers of cardiovascular health in humans and to identify possible involved nutrigenomic mechanisms.
Read the detailed description
Mate is a traditional drink obtained from the leaves of yerba-mate (Ilex paraguariensis A.St.-Hil.), a native species of South America that has a great regional importance. Mate is highly consumed in South America countries because of the tradition acquired from the native populations. In these countries, mate is consumed as largely as tea (camellia sinensis) in Asia and Europe and coffee in Europe and North America. Mate constitutes a raw material little explored compared to other plant products like coffee or tea. However, mate product has recently raised interest due to both its high content of phytochemicals and the peculiarity of its phenolic profile, characterized by the wealth in mono and dicaffeoylquinic acids, known for their biological activities.
A large number of in vitro studies have evaluated the antioxidant capacity of mate products with different methodologies, and showed that the antioxidant effect was related to the presence of caffeoyl derivatives. Mate appears as a potent inhibitor of low-density lipoproteins (LDL) oxidation. The phenolic compounds of mate also exhibit free radical scavenging properties and inhibit a chemically induced oxidation of lipid in membranes. Different animal studies have reported a positive impact of mate consumption on some cardiovascular risk factors. These published data, obtained in different rodent models of diet induced dyslipidemia, obesity or atherosclerosis, suggest that the supplementation with mate products may improve plasma lipids profile, prevent hepatic fatty deposition, reduce insulin resistance, improve endothelial function and inhibit atherosclerosis progression. Few clinical studies reported positive effects of mate consumption on the blood lipid profile, glycemia and anthropometric parameters in healthy and unhealthy subjects.
The aim of this study is to assess through a randomized controlled trial the impact of chronic intake of mate on intermediate biomarkers of cardiovascular health in humans and to identify possible nutrigenomic mechanisms involved.
The study consists in a controlled, randomized, double blind, crossover clinical trial. This study will involve 36 healthy middle-age (45-65) male subjects selected according to the inclusion and exclusion criteria previously established. The study will have a maximum duration of 84 days including the wash-out period. The volunteers will have to consume daily for 4 weeks the mate extract (with a standardized content in phenolic compounds) or the placebo. At the beginning and/or at the end of each experimental period, blood will be sampled for measurement of glycemic and lipidic parameters, inflammatory markers and transcriptome analysis. Urine samples will also be collected for metabolomics analysis to characterize the exposure profile of volunteers in response to mate phenolic compounds consumption.
- Conditions
- Cardiovascular Disease, Diabetes
- Being tested
- Yerba Mate Extract, Placebo
- Keywords
- Mate, Vascular protection, Endothelial function, Ilex paraguariensis
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yerba Mate ExtractOther
Yerba Mate extract capsules 750 mg
PlaceboOther
Take 3 capsules, 3 times daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Yerba Mate Extract 750 mg | Experimental | Yerba Mate Extract - Capsules: daily dose of 2.250 g, distributed in 3 doses of 750 mg, for 28 days. Receives: Other: Yerba Mate Extract |
| Placebo | Placebo comparator | Starch - Capsules: 3 times daily for 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of biochemical parameters: total cholesterol and fractions, triglycerides and fasting glucose.
Cholesterol - Enzymatic colorimetric method; HDL cholesterol - lipoproteins VLDL (very low density lipoprotein) and LDL (Low Density Lipoprotein) and chylomicrons are precipitated with a mixture of phosphotungstic acid and magnesium chloride. After centrifugation, the bound cholesterol to high density lipoproteins (HDL) in the supernatant determined by colorimetric enzymatic method; Triglycerides - Enzymatic colorimetric method; Fasting glucose - enzymatic colorimetric method.
All results are expressed in mg / dL.
Measured: 28 days
Quantification of inflammatory markers: C-reactive protein.
C-reactive protein (CRP) - Kit using turbidimetric methods for the quantitative
Measured: after 28 days of treatment
Quantification of adhesion molecule:Endothelin, Intercellular adhesion molecule (ICAM-1) and vascular endothelial cell adhesion molecule (VCAM-1).
Endothelin (EDN-1) - using enzyme immunoassay kit (ELISA) for the quantification in vitro EDN-1 in human serum. Evaluation kit for using enzyme immunoassay technique (ELISA) for the quantitative in vitro determination of ICAM-1 and VCAM-1 in human serum. The results of analyzes are expressed in ng/ml.
Measured: 28 days
Quantification of inflammatory markers: Interleukin-6.
Interleukin-6 (IL-6) - Evaluation kit for using enzyme immunoassay technique (ELISA) for the quantitative determination of IL-6 in vitro in human serum. The results of analyzes for IL-6 are expressed in ng/ml.
Measured: after 28 days of treatment
Evaluation of the tolerance glucose.
Oral Glucose Tolerance Test OGTT (in mg/dL). A standard anhydrous glucose load will be administered and evaluation of Oral Glucose Test Tolerance (OGTT) after consumption of a high sugar load.
Measured: after 28 days of treatment
Evaluation of transcriptome analysis.
Profile Evaluation of leukocyte gene expression through nutrigenomics study after consumption capsules containing standardized amount of yerba mate. The genes involved in lipid metabolism are isolated, identified and quantitated by real-time PCR technique. The results are expressed according to the identification and the number of genes.
Measured: after 28 days of treatment
Secondary outcomes (4)
Clinical evaluation: arterial pressure (mean of three measurements for each 5 minutes).
Measured: 28 days
Clinical evaluation: waist circumference.
Measured: 28 days
Clinical evaluation: pulse.
Measured: 28 days
Clinical evaluation: weight.
weight in kg
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start15 Aug 2016
- Primary completion30 Jun 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karimi Sater Gebara
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor-investigator, Karimi Sater Gebara, Universidade Paranaense
- Investigators
- Karimi S Gebara, MSc, Study chair, Universidade Federal da Grande DouradosEuclides L Cardozo Júnior, PhD, Principal investigator, Universidade Paranaense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789722
- Sponsor's protocol ID
- UNP-ILCV-1518
- Acronym
- YMCH-2015
- Status last verified
- May 2018
- First submitted
- 28 Feb 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Filip R, Lopez P, Giberti G, Coussio J, Ferraro G. Phenolic compounds in seven South American Ilex species. Fitoterapia. 2001 Nov;72(7):774-8. doi: 10.1016/s0367-326x(01)00331-8.
PubMed 11677016Alikaridis F. Natural constituents of Ilex species. J Ethnopharmacol. 1987 Jul;20(2):121-44. doi: 10.1016/0378-8741(87)90084-5.
PubMed 3657245Cardozo EL Jr, Cardozo-Filho L, Filho OF, Zanoelo EF. Selective liquid CO2 extraction of purine alkaloids in different Ilex paraguariensis progenies grown under environmental influences. J Agric Food Chem. 2007 Aug 22;55(17):6835-41. doi: 10.1021/jf0706225. Epub 2007 Jul 25.
PubMed 17650001Ghosh D, Scheepens A. Vascular action of polyphenols. Mol Nutr Food Res. 2009 Mar;53(3):322-31. doi: 10.1002/mnfr.200800182.
PubMed 19051188Cardozo Junior EL, Morand C. Interest of Mate (Ilex paraguariensis A.St.-Hil.) as a new natural functional food to preserve human cardiovascular health - A review. Journal of Functional Foods 21: 440-454, 2016.
Arts IC, Hollman PC. Polyphenols and disease risk in epidemiologic studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):317S-325S. doi: 10.1093/ajcn/81.1.317S.
PubMed 15640497Balzan S, Hernandes A, Reichert CL, Donaduzzi C, Pires VA, Gasparotto A Jr, Cardozo EL Jr. Lipid-lowering effects of standardized extracts of Ilex paraguariensis in high-fat-diet rats. Fitoterapia. 2013 Apr;86:115-22. doi: 10.1016/j.fitote.2013.02.008. Epub 2013 Feb 17.
PubMed 23422228Chanet A, Milenkovic D, Deval C, Potier M, Constans J, Mazur A, Bennetau-Pelissero C, Morand C, Berard AM. Naringin, the major grapefruit flavonoid, specifically affects atherosclerosis development in diet-induced hypercholesterolemia in mice. J Nutr Biochem. 2012 May;23(5):469-77. doi: 10.1016/j.jnutbio.2011.02.001. Epub 2011 Jun 17.
PubMed 21684135Hooper L, Kroon PA, Rimm EB, Cohn JS, Harvey I, Le Cornu KA, Ryder JJ, Hall WL, Cassidy A. Flavonoids, flavonoid-rich foods, and cardiovascular risk: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2008 Jul;88(1):38-50. doi: 10.1093/ajcn/88.1.38.
PubMed 18614722
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Yerba Mate (Ilex Paraguariensis A.St.-Hil.) Products on the Promotion of Health: Assessment of Cardiovascular Health
- ClinicalTrials.gov ID
- NCT02789722
- Acronym / sponsor ID
- YMCH-2015 / UNP-ILCV-1518
- Conditions
- Cardiovascular Disease, Diabetes
- Keywords
- Mate, Vascular protection, Endothelial function, Ilex paraguariensis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karimi Sater GebaraUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Jun 2016 (estimated)
- 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.
Mate or yerba-mate (Ilex paraguariensis A.St.-Hil.) is a native plant from South America highly consumed in this region. Different traditional products (mate, mate tea, chimarrao, tereré) are obtained from the yerba-mate leaves and consumed as herbal tea. Mate is a rich source of bioactive phenolic compounds, mainly caffeoylquinic acids. The richness of different mono- and dicaffeoylquinic acids is a peculiarity of mate derived products. However, in contrast to other plant-based beverages rich in polyphenols like tea or coffee, the research and the industry have yet little explored the potential interest of mate product to promote human health. There has been a growing interest to the development of healthier foods to face the burden of cardiovascular diseases (CVD), especially those naturally rich in bioactive phenolic compounds with protective effects against the development of chronic diseases. Different in vitro and animals studies associate the mate consumption with cardiovascular protection mechanisms. Consistent information about this activity and the long-term consumption effects in humans are scarce. The aim of this study is to assess through a randomized controlled trial the impact of chronic intake of mate on intermediate biomarkers of cardiovascular health in humans and to identify possible involved nutrigenomic mechanisms.
Detailed description
Mate is a traditional drink obtained from the leaves of yerba-mate (Ilex paraguariensis A.St.-Hil.), a native species of South America that has a great regional importance. Mate is highly consumed in South America countries because of the tradition acquired from the native populations. In these countries, mate is consumed as largely as tea (camellia sinensis) in Asia and Europe and coffee in Europe and North America. Mate constitutes a raw material little explored compared to other plant products like coffee or tea. However, mate product has recently raised interest due to both its high content of phytochemicals and the peculiarity of its phenolic profile, characterized by the wealth in mono and dicaffeoylquinic acids, known for their biological activities.
A large number of in vitro studies have evaluated the antioxidant capacity of mate products with different methodologies, and showed that the antioxidant effect was related to the presence of caffeoyl derivatives. Mate appears as a potent inhibitor of low-density lipoproteins (LDL) oxidation. The phenolic compounds of mate also exhibit free radical scavenging properties and inhibit a chemically induced oxidation of lipid in membranes. Different animal studies have reported a positive impact of mate consumption on some cardiovascular risk factors. These published data, obtained in different rodent models of diet induced dyslipidemia, obesity or atherosclerosis, suggest that the supplementation with mate products may improve plasma lipids profile, prevent hepatic fatty deposition, reduce insulin resistance, improve endothelial function and inhibit atherosclerosis progression. Few clinical studies reported positive effects of mate consumption on the blood lipid profile, glycemia and anthropometric parameters in healthy and unhealthy subjects.
The aim of this study is to assess through a randomized controlled trial the impact of chronic intake of mate on intermediate biomarkers of cardiovascular health in humans and to identify possible nutrigenomic mechanisms involved.
The study consists in a controlled, randomized, double blind, crossover clinical trial. This study will involve 36 healthy middle-age (45-65) male subjects selected according to the inclusion and exclusion criteria previously established. The study will have a maximum duration of 84 days including the wash-out period. The volunteers will have to consume daily for 4 weeks the mate extract (with a standardized content in phenolic compounds) or the placebo. At the beginning and/or at the end of each experimental period, blood will be sampled for measurement of glycemic and lipidic parameters, inflammatory markers and transcriptome analysis. Urine samples will also be collected for metabolomics analysis to characterize the exposure profile of volunteers in response to mate phenolic compounds consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yerba Mate Extract 750 mg | Experimental | Other: Yerba Mate ExtractYerba Mate Extract - Capsules: daily dose of 2.250 g, distributed in 3 doses of 750 mg, for 28 days. |
| Placebo | Placebo comparator | Other: PlaceboStarch - Capsules: 3 times daily for 28 days. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No smoking, or having stopped smoking for more than three years;
- Having no more than one of the five criteria associated with metabolic syndrome proposed by the National Cholesterol Education Program's Adult Treatment Panel III (NCEP-ATP III) and approved by Brazilian scientific societies in the First Brazilian Guideline for Diagnosis and Treatment of Metabolic Syndrome (2005);
- Not consuming multivitamin supplements, antioxidants or polyphenols rich products in the last 3 months before the study;
- Accepting reduced consumption of natural polyphenols rich beverages (yerba mate, tea, coffee, wine, cocoa, soy milk, fruit juices) during the study;
- Not using any antihypertensive or anticholesterolemic drugs;
Key exclusion criteria (5 listed)
- Being diagnosed with diabetes, mental illness or other severe conditions that may influence the results of the study;
- Chronic alcoholism;
- Having severe hypertension with clinical complications such as acute myocardial infarction and other coronary artery diseases;
- Having kidney or liver diseases;
- Not accepting to participate in the study refusing to sign the Informed Consent, in accordance with the fundamental ethical and scientific requirements.
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 ExtractYerba Mate extract capsules 750 mg | Other | Yerba Mate Extract 750 mg |
| PlaceboTake 3 capsules, 3 times daily for 28 days. | Other | Placebo |
Primary outcome
Quantification of biochemical parameters: total cholesterol and fractions, triglycerides and fasting glucose.
Time frame: 28 days
Cholesterol - Enzymatic colorimetric method; HDL cholesterol - lipoproteins VLDL (very low density lipoprotein) and LDL (Low Density Lipoprotein) and chylomicrons are precipitated with a mixture of phosphotungstic acid and magnesium chloride. After centrifugation, the bound cholesterol to high density lipoproteins (HDL) in the supernatant determined by colorimetric enzymatic method; Triglycerides - Enzymatic colorimetric method; Fasting glucose - enzymatic colorimetric method. All results are expressed in mg / dL.
Quantification of inflammatory markers: C-reactive protein.
Time frame: after 28 days of treatment
C-reactive protein (CRP) - Kit using turbidimetric methods for the quantitative
Quantification of adhesion molecule:Endothelin, Intercellular adhesion molecule (ICAM-1) and vascular endothelial cell adhesion molecule (VCAM-1).
Time frame: 28 days
Endothelin (EDN-1) - using enzyme immunoassay kit (ELISA) for the quantification in vitro EDN-1 in human serum. Evaluation kit for using enzyme immunoassay technique (ELISA) for the quantitative in vitro determination of ICAM-1 and VCAM-1 in human serum. The results of analyzes are expressed in ng/ml.
Quantification of inflammatory markers: Interleukin-6.
Time frame: after 28 days of treatment
Interleukin-6 (IL-6) - Evaluation kit for using enzyme immunoassay technique (ELISA) for the quantitative determination of IL-6 in vitro in human serum. The results of analyzes for IL-6 are expressed in ng/ml.
Evaluation of the tolerance glucose.
Time frame: after 28 days of treatment
Oral Glucose Tolerance Test OGTT (in mg/dL). A standard anhydrous glucose load will be administered and evaluation of Oral Glucose Test Tolerance (OGTT) after consumption of a high sugar load.
Evaluation of transcriptome analysis.
Time frame: after 28 days of treatment
Profile Evaluation of leukocyte gene expression through nutrigenomics study after consumption capsules containing standardized amount of yerba mate. The genes involved in lipid metabolism are isolated, identified and quantitated by real-time PCR technique. The results are expressed according to the identification and the number of genes.
4 secondary outcomes
Clinical evaluation: arterial pressure (mean of three measurements for each 5 minutes).
Time frame: 28 days
Clinical evaluation: waist circumference.
Time frame: 28 days
Clinical evaluation: pulse.
Time frame: 28 days
Clinical evaluation: weight.
Time frame: 28 days
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 8 May 2018.
- Background: PubMed 11677016Filip R, Lopez P, Giberti G, Coussio J, Ferraro G. Phenolic compounds in seven South American Ilex species. Fitoterapia. 2001 Nov;72(7):774-8. doi: 10.1016/s0367-326x(01)00331-8.
- Background: PubMed 3657245Alikaridis F. Natural constituents of Ilex species. J Ethnopharmacol. 1987 Jul;20(2):121-44. doi: 10.1016/0378-8741(87)90084-5.
- Background: PubMed 17650001Cardozo EL Jr, Cardozo-Filho L, Filho OF, Zanoelo EF. Selective liquid CO2 extraction of purine alkaloids in different Ilex paraguariensis progenies grown under environmental influences. J Agric Food Chem. 2007 Aug 22;55(17):6835-41. doi: 10.1021/jf0706225. Epub 2007 Jul 25.
- Background: PubMed 19051188Ghosh D, Scheepens A. Vascular action of polyphenols. Mol Nutr Food Res. 2009 Mar;53(3):322-31. doi: 10.1002/mnfr.200800182.
- BackgroundCardozo Junior EL, Morand C. Interest of Mate (Ilex paraguariensis A.St.-Hil.) as a new natural functional food to preserve human cardiovascular health - A review. Journal of Functional Foods 21: 440-454, 2016.
- Results publication: PubMed 15640497Arts IC, Hollman PC. Polyphenols and disease risk in epidemiologic studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):317S-325S. doi: 10.1093/ajcn/81.1.317S.
- Results publication: PubMed 23422228Balzan S, Hernandes A, Reichert CL, Donaduzzi C, Pires VA, Gasparotto A Jr, Cardozo EL Jr. Lipid-lowering effects of standardized extracts of Ilex paraguariensis in high-fat-diet rats. Fitoterapia. 2013 Apr;86:115-22. doi: 10.1016/j.fitote.2013.02.008. Epub 2013 Feb 17.
- Results publication: PubMed 21684135Chanet A, Milenkovic D, Deval C, Potier M, Constans J, Mazur A, Bennetau-Pelissero C, Morand C, Berard AM. Naringin, the major grapefruit flavonoid, specifically affects atherosclerosis development in diet-induced hypercholesterolemia in mice. J Nutr Biochem. 2012 May;23(5):469-77. doi: 10.1016/j.jnutbio.2011.02.001. Epub 2011 Jun 17.
- Results publication: PubMed 18614722Hooper L, Kroon PA, Rimm EB, Cohn JS, Harvey I, Le Cornu KA, Ryder JJ, Hall WL, Cassidy A. Flavonoids, flavonoid-rich foods, and cardiovascular risk: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2008 Jul;88(1):38-50. doi: 10.1093/ajcn/88.1.38.
- Individual participant dataSharing planned: Undecided
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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.
Karimi S Gebara, MSc study chair
Universidade Federal da Grande Dourados
Euclides L Cardozo Júnior, PhD principal investigator
Universidade Paranaense
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 Extract in people with Cardiovascular Disease and Diabetes, run by Karimi Sater Gebara 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 6 inclusion and 5 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 8 May 2018. 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?
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?
Quantification of biochemical parameters: total cholesterol and fractions, triglycerides and fasting glucose. (time frame: 28 days). 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?
On the ClinicalTrials.gov record for NCT02789722, which also lists 9 linked publications.
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 8 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.