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

NCT02789722 | Completed DMC

• 1 other identifier: UNP-ILCV-1518
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Diabetes

Keywords

Mate; Vascular protection; Endothelial function; Ilex paraguariensis

Outcome Measures

Primary Outcomes (6)

• 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.

  28 days

• Quantification of inflammatory markers: C-reactive protein.

  C-reactive protein (CRP) - Kit using turbidimetric methods for the quantitative

  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.

  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.

  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.

  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.

  after 28 days of treatment

Secondary Outcomes (4)

• Clinical evaluation: arterial pressure (mean of three measurements for each 5 minutes).

  28 days

• Clinical evaluation: waist circumference.

  28 days

• Clinical evaluation: pulse.

  28 days

• Clinical evaluation: weight.

  28 days

Study Arms (2)

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.

Other: Yerba Mate Extract

Placebo

PLACEBO COMPARATOR

Starch - Capsules: 3 times daily for 28 days.

Other: Placebo

Interventions

Yerba Mate Extract OTHER

Yerba Mate extract capsules 750 mg

Yerba Mate Extract 750 mg

Placebo OTHER

Take 3 capsules, 3 times daily for 28 days.

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karimi Sater Gebara: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (1)

Euclides Lara Cardozo Júnior

Toledo, Paraná, 85.900-000, Brazil

Location

Related Publications (9)

• 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.

  PMID: 11677016 BACKGROUND

• Alikaridis F. Natural constituents of Ilex species. J Ethnopharmacol. 1987 Jul;20(2):121-44. doi: 10.1016/0378-8741(87)90084-5.

  PMID: 3657245 BACKGROUND

• Cardozo 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.

  PMID: 17650001 BACKGROUND

• Ghosh D, Scheepens A. Vascular action of polyphenols. Mol Nutr Food Res. 2009 Mar;53(3):322-31. doi: 10.1002/mnfr.200800182.

  PMID: 19051188 BACKGROUND

• Cardozo 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.

  BACKGROUND

• 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.

  PMID: 15640497 RESULT

• Balzan 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.

  PMID: 23422228 RESULT

• Chanet 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.

  PMID: 21684135 RESULT

• Hooper 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.

  PMID: 18614722 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Karimi S Gebara, MSc

  Universidade Federal da Grande Dourados

  STUDY CHAIR

• Euclides L Cardozo Júnior, PhD

  Universidade Paranaense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: June 3, 2016
• Study Start: August 15, 2016
• Primary Completion: June 30, 2017
• Study Completion: May 1, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

BR (1)