Study of the Effects of Yerba Mate on Cardiometabolic Health (INFU-SALUD)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk; Hypercholerolemia
• Intervention / Treatment: Dietary supplement: Yerba mate tea; Dietary supplement: Control drink

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yerba mate; Consumption of three cups of a yerba mate tea per day	Dietary supplement: Yerba mate tea; Consumption of three cups per day of a beverage prepared with yerba mate
Other: Control; Consuming water or an isotonic drink, free of polyphenols or caffeine.	Dietary supplement: Control drink; Consumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
• Collaborators: Ministry of Science and Innovation, Spain
• Investigators: Principal Investigator: Laura Bravo, Professor, ICTAN-CSIC

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2012
• Primary Completion (Actual): July 30, 2013
• Study Completion (Actual): May 30, 2015

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 7, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Blood lipids; Glucose homeostasis; Cardiovascular health; Yerba mate
• Other Study ID Numbers: AGL2010-18269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No