Study of the Effects of Yerba Mate on Cardiometabolic Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-10

Study Completion Date

2015-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Risk Hypercholerolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Yerba mate

Consumption of three cups of a yerba mate tea per day

Group Type EXPERIMENTAL

Yerba mate tea

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type OTHER

Control drink

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Yerba mate tea

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

Intervention Type DIETARY_SUPPLEMENT

Control drink

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes