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Yerba Mate (Ilex Paraguariensis A.St.-Hil.): Assessment of Cardiovascular Health (YMCH-2015)

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ClinicalTrials.gov Identifier: NCT02789722
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Institut National de la Recherche Agronomique
Information provided by (Responsible Party):
Karimi Sater Gebara, Universidade Paranaense

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetes Other: Yerba Mate Extract Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Application of Yerba Mate (Ilex Paraguariensis A.St.-Hil.) Products on the Promotion of Health: Assessment of Cardiovascular Health
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yerba Mate Extract 750 mg
Yerba Mate Extract - Capsules: daily dose of 2.250 g, distributed in 3 doses of 750 mg, for 28 days.
Other: Yerba Mate Extract
Yerba Mate extract capsules 750 mg

Placebo Comparator: Placebo
Starch - Capsules: 3 times daily for 28 days.
Other: Placebo
Take 3 capsules, 3 times daily for 28 days.




Primary Outcome Measures :
  1. 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.


  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Clinical evaluation: arterial pressure (mean of three measurements for each 5 minutes). [ Time Frame: 28 days ]
  2. Clinical evaluation: waist circumference. [ Time Frame: 28 days ]
  3. Clinical evaluation: pulse. [ Time Frame: 28 days ]
  4. Clinical evaluation: weight. [ Time Frame: 28 days ]
    weight in kg



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789722


Locations
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Brazil
Euclides Lara Cardozo Júnior
Toledo, Paraná, Brazil, 85.900-000
Sponsors and Collaborators
Karimi Sater Gebara
Institut National de la Recherche Agronomique
Investigators
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Study Chair: Karimi S Gebara, MSc Universidade Federal da Grande Dourados
Principal Investigator: Euclides L Cardozo Júnior, PhD Universidade Paranaense
Publications of Results:
Other Publications:
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Responsible Party: Karimi Sater Gebara, Master, Universidade Paranaense
ClinicalTrials.gov Identifier: NCT02789722    
Other Study ID Numbers: UNP-ILCV-1518
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Karimi Sater Gebara, Universidade Paranaense:
Mate
Vascular protection
Endothelial function
Ilex paraguariensis
Additional relevant MeSH terms:
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Cardiovascular Diseases