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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Diabetes||Other: Yerba Mate Extract Other: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
Take 3 capsules, 3 times daily for 28 days.
- 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.
- 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 ]weight in kg
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
|Euclides Lara Cardozo Júnior|
|Toledo, Paraná, Brazil, 85.900-000|
|Study Chair:||Karimi S Gebara, MSc||Universidade Federal da Grande Dourados|
|Principal Investigator:||Euclides L Cardozo Júnior, PhD||Universidade Paranaense|