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| Name | Class |
|---|---|
| Ministry of Science and Innovation, Spain | OTHER_GOV |
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The goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. It will also learn about the effects of this beverage, widely consumed in South America, on other cardiometabolic biomarkers like blood glucose levels, inflammation, or weight control. The main questions it aims to answer are:
Does daily consumption of a yerba mate tea reduce the blood lipid levels in hypercholesterolemic persons? May healthy persons also benefit from the consumption of yerba mate tea?
Researchers will compare yerba mate to a control drink (isotonic drink or water, free of polyphenols and caffeine) to see if yerba mate tea helps to reduce blood cholesterol in hypercholesterolemic persons.
Participants will:
Drink 3 cups of yerba mate tea or an isotonic drink every day for 2 months, then change to the other drink during another 2 months.
Visit the clinic at the beginning and end of each 2-month period for checkups and tests Refraing from consuming coffee and some foods during the study. Complete a dietary questionnaire during 3 days before each visit to the clinic.
This is a randomized, crossover, control study in healthy and hypercholesterolemic free-living to assess the effect of yerba mate on different outcomes related to cardiovascular health.
After a 2-week run-in period, participants will be randomly allocated to the first 8-weeks intervention with yerba mate or the control drink. After a 3-week wash-out, they will change to consume during 8 weeks the other drink.
A nurse will collect a fasting blood sample at the beginning and end of each intervention stage. Blood pressure and anthropometric parameters will be measured. A 72-h dietary record will be completed by participants before each visit to the Human Nutrition Unit (HNU) at the Institute of Food Science, Technology and Nutrition (ICTAN-CSIC).
During the study, participants will refrain from consuming coffee, cocoa, tea, and caffeine-containing drinks. Other foods rich in certain polyphenols (i.e. hydroxycinnamic acids) will also be restricted.
Blood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the Outcomes section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yerba mate | Experimental | Consumption of three cups of a yerba mate tea per day |
|
| Control | Other | Consuming water or an isotonic drink, free of polyphenols or caffeine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yerba mate tea | Dietary Supplement | Consumption of three cups per day of a beverage prepared with yerba mate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids | Change in blood levels of total cholesterol or LDL-cholesterol or VLDL-cholesterol or HDL-cholesterol or triglycerides or phospholipids at the end of the intervention with yerba mate | From enrollment to the end of each treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Changes in blood pressure at the end of the intervention with yerba mate. | From enrollment to the end of each treatment at 8 weeks |
| Inflammatory cytokines | Change in the levels of C-reactive protein (CRP), or pro-inflammatory cytokines (tumor necrosis factor-alpha (TNF-a), or interferon gamma (IFN-g), interleukin (IL)-1beta (IL-1b), or IL-2, or IL-5, or IL-6, or IL-7, or IL-8, or IL-12 or IL-13)) or anti-inflammatory cytokines IL-4 or IL-10 at the end of the intervention with yerba mate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Bravo, Professor | ICTAN-CSIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ciencia y TecnologÃa de Alimentos y Nutrición | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40263915 | Derived | Bravo L, Martinez-Lopez S, Sierra-Cinos JL, Mateos R, Sarria B. Yerba Mate (Ilex paraguariensis St. Hill.) Tea May Have Cardiometabolic Beneficial Effects in Healthy and At-Risk Subjects: A Randomized, Controlled, Blind, Crossover Trial in Nonhabitual Consumers. Mol Nutr Food Res. 2025 Aug;69(15):e70065. doi: 10.1002/mnfr.70065. Epub 2025 Apr 22. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Control drink | Dietary Supplement | Consumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee. |
|
| From enrollment to the end of each treatment at 8 weeks |
| Fasting blood glucose | Change of fasting blood glucose levels at the end of the intervention with yerba mate | From enrollment to the end of each treatment at 8 weeks |
| Fasting blood insulin | Change of fasting insulin levels at the end of intervention with yerba mate | From enrollment to the end of each treatment at 8 weeks |
| Insulin resistance | Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) at the end of intervention with yerba mate | From enrollment to the end of each treatment at 8 weeks |
| Insulin sensitivity | Change in quantitative insulin levels sensitivity check index (QUICKI) at the end of the intervention with yerba mate. Higher score in QUICKI means a better outcome compared to initial values. | From enrollment to the end of each treatment at 8 weeks |
| Hormones, incretins and adipokines levels | Changes in serum levels of C peptide or glucagon or glucagon inhibitory peptide (GIP) or glucagon-like peptide type 1 (GLP-1) or ghrelin or leptin or resistin or plasminogen activator inhibitor type 1 (PAI-1) or visfatin at the end of the intervention with yerba mate. | From enrollment to the end of each treatment at 8 weeks |
| Cytokines, chemokines and cell-adherence molecules levels | Changes in serum levels of granulocyte (G-CSF) or granulocyte/macrophague (GM-CSF) colony-stimulating factors, or monocyte-chemoattractant protein-1 (MCP-1) or macrophage inflammatory protein-1beta (MIP-1b) or vascular (VCAM-1) or intracellular (ICAM-1) adhesion molecules at the end of the intervention with yerba mate. | From enrollment to the end of each treatment at 8 weeks |
| Liver function | No changes in serum levels of alanin transferase (ALAT), or aspartate transferase (ASAT) at the end of the intervention with yerba mate. | From enrollment to the end of each treatment at 8 weeks |
| Anthropometry | Changes in body weight or body fat percentage or body circunferences (wais, or hip, or thigh, or brachial) or skinfolds (tricipital or subscapular) at the end of the intervention with yerba mate. | From enrollment to the end of each treatment at 8 weeks |