NCT06729905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2015

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

December 7, 2024

Last Update Submit

May 18, 2025

Conditions

Cardiovascular RiskHypercholerolemia

Keywords

Yerba mateCardiovascular healthInflammationBlood lipidsGlucose homeostasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Blood pressure

    From enrollment to the end of each treatment at 8 weeks

  • Inflammatory cytokines

    From enrollment to the end of each treatment at 8 weeks

  • Fasting blood glucose

    From enrollment to the end of each treatment at 8 weeks

  • Fasting blood insulin

    From enrollment to the end of each treatment at 8 weeks

  • Insulin resistance

    From enrollment to the end of each treatment at 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Yerba mate

EXPERIMENTAL

Consumption of three cups of a yerba mate tea per day

Dietary Supplement: Yerba mate tea

Control

OTHER

Consuming water or an isotonic drink, free of polyphenols or caffeine.

Dietary Supplement: Control drink

Interventions

Yerba mate teaDIETARY_SUPPLEMENT

Consumption of three cups per day of a beverage prepared with yerba mate

Yerba mate
Control drinkDIETARY_SUPPLEMENT

Consumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee.

Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 40263915DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Bravo, Professor

    ICTAN-CSIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2024

First Posted

December 12, 2024

Study Start

January 10, 2012

Primary Completion

July 30, 2013

Study Completion

May 30, 2015

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)