Cardiovascular Risk, Hypercholerolemia
Conditions
Keywords
Yerba mate, Cardiovascular health, Inflammation, Blood lipids, Glucose homeostasis
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTYerba mate tea
Consumption of three cups per day of a beverage prepared with yerba mate
DIETARY_SUPPLEMENTControl drink
Consumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee.
Sponsors
Ministry of Science and Innovation, Spain
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 20-25 kg/m2 * Total cholesterol \< 200 mg/dL for healthy participants, between 200-240 mg/dL for participants at cardiovascular risk, or * LDL cholesterol \< 130 mg/dL for healthy participants, between 130-159 mg/dL for participants at cardiovascular risk.
Exclusion criteria
* Smoking * Pregnant/lactating women * Vegetarians/vegans * Consumption of vitamins or dietary supplements * Suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia * On prescription drugs (statins) or on antibiotics 6 months before the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood lipids | From enrollment to the end of each treatment at 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory cytokines | From enrollment to the end of each treatment at 8 weeks | 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 |
| Fasting blood glucose | From enrollment to the end of each treatment at 8 weeks | Change of fasting blood glucose levels at the end of the intervention with yerba mate |
| Fasting blood insulin | From enrollment to the end of each treatment at 8 weeks | Change of fasting insulin levels at the end of intervention with yerba mate |
| Insulin resistance | From enrollment to the end of each treatment at 8 weeks | Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) at the end of intervention with yerba mate |
| Blood pressure | From enrollment to the end of each treatment at 8 weeks | Changes in blood pressure at the end of the intervention with yerba mate. |
| Hormones, incretins and adipokines levels | From enrollment to the end of each treatment at 8 weeks | 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. |
| Cytokines, chemokines and cell-adherence molecules levels | From enrollment to the end of each treatment at 8 weeks | 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. |
| Liver function | From enrollment to the end of each treatment at 8 weeks | No changes in serum levels of alanin transferase (ALAT), or aspartate transferase (ASAT) at the end of the intervention with yerba mate. |
| Anthropometry | From enrollment to the end of each treatment at 8 weeks | 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. |
| Insulin sensitivity | From enrollment to the end of each treatment at 8 weeks | 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. |
Countries
Spain
Outcome results
None listed