Clinical TrialID 15
Yerba Mate (Ilex Paraguariensis A.St.-Hil.): Assessment of Cardiovascular Health
NCT02789722
Cardiovascular Disease|Diabetes
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Trial: 1Herb: 1Links: 1
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 15
- Evidence Id
- 15
- Core Evidence Id
- 15
- Source Clinical Trial Id
- 10
- Herb2 Clinical Trial Id
- HBCT000010
- Nct Id
- NCT02789722
- Title
- Yerba Mate (Ilex Paraguariensis A.St.-Hil.): Assessment of Cardiovascular Health
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Cardiovascular Disease|Diabetes
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
- Intervention
- OTHER: Yerba Mate Extract|OTHER: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Triple
- Intervention Purpose
- Prevention
- Gender
- Male
- Age
- Adult, Older_Adult
- Enrollment
- 34
- Outcome Measure
- 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
- Sponsor Collaborator
- Karimi Sater Gebara|Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Funded By
- OTHER
- Location
- Euclides Lara Cardozo Júnior, Toledo, Paraná, 85.900-000, Brazil
- Other Id
- UNP-ILCV-1518
- Start Date
- 2016-08-15
- Primary Completion Date
- 2017-06-30
- Completion Date
- 2018-05
- First Posted
- 2016-06-03
- Results First Posted
- Last Update Posted
- 2018-05-08
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02789722
- Title Cn
- Title En
- Yerba Mate (Ilex Paraguariensis A.St.-Hil.): Assessment of Cardiovascular Health
- Bilingual Status
- semi_complete