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Sports PerformanceNCT04642144

Effect of Infusion of Yerba Mate on Oxidative Stress, Physiology, and Performance of Trained Cyclists

A study testing Yerba mate infusion and Carbohydrate meal in people with Sports Performance and Sports Nutritional Sciences, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project comes forward with investigations regarding the use of yerba mate infusion in sports performance, providing new knowledge about the effects of its consumption on the performance of trained individuals, thus elucidating new mechanisms of ergogenic action of the plant in characteristics of dietary… Read more about this study

Who is it for?
Ages 25 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
Yerba mate infusion and Carbohydrate meal
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteBrazil
Study dates
20 Nov 2020to 21 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male
  • Age between 20 and 45 years
  • Minimum of two years of experience with training and competitions

Who cannot join

  • Individuals who present clinical condition of disease
  • Smokers
  • Continuous use of medications and/or dietary supplements
  • Show aversion, intolerance, or complications resulting from ingesting the YERBA MATE infusion or any of its components

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Department of Nutrition

    Florianópolis, Santa Catarina, 88040-900

Other trials in Brazil

About this study

Official title: Effect of Infusion of Yerba Mate (Ilex Paraguariensis) Associated or Not With Carbohydrate Intake on Oxidative Stress, Pshysiological and Performance Parameters of Trained Cyclists

This project comes forward with investigations regarding the use of yerba mate infusion in sports performance, providing new knowledge about the effects of its consumption on the performance of trained individuals, thus elucidating new mechanisms of ergogenic action of the plant in characteristics of dietary management indicated for trained individuals, besides investigating on the action of the bioactive compounds of the plant in the metabolism and performance of athletes and the physiological aspects.

Read the detailed description

In this study, participants will be randomized into three groups: a group with yerba mate infusion and carbohydrate meal, a group with only yerba mate infusion, and a group with water and carbohydrate. The washout period between treatments will be seven days. The experimental protocol will be carried out in the same period of the day (± 3h) to minimize the interference of biological variations.

Before starting the procedures for data collection, the individuals invited to participate in the study will be informed about the objectives and methods of the research and then, if accepted, they will sign the informed consent form. The study will be divided into four stages (baseline and the three different interventions). The baseline period comprises two meetings, the first of which is to carry out a questionnaire to identify the participant, to carry out blood collection of the intermediate vein of the arm, to make the analysis of body composition and to be instructed on the exercise and feeding procedures during the experimental protocol. In the second meeting of the baseline period, the participants will be submitted to an incremental protocol on the cycle ergometer, and the data from this test will be used for the application of the experimental exercise protocol performed later with dietary interventions. From the incremental test, the maximum aerobic power, peak oxygen volume, maximum heart rate, and lactate thresholds, energy substrate consumption, and perceived exertion will be determined. In the three visits following the baseline period, according to randomization, interventions will be carried out with the infusion of yerba mate and carbohydrate meal, with only the infusion of yerba mate and with water and carbohydrate meal. In intervention groups with yerba mate infusion, participants will be asked to ingest seven days before the exercise protocol the same amount of yerba mate infusion as the test day (250 mL). In this way, individual packages of ultra-refined yerba mate containing 5 g, the necessary materials, and guidelines for the proper preparation of the infusion will be provided. In groups that receive the carbohydrate meal, participants will be offered, one hour before starting the exercise protocol, white bread with corn syrup, which will be adjusted to their individual carbohydrate needs, in quantities that make up a total of 1g of carbohydrate per kg of bodyweight of the participant, as recommended by the American College of Sports Medicine and the Academy of Nutrition and Dietetics, Dietitians of Canada.

In all visits, participants will be instructed to arrive at the physical effort laboratory of the Federal University of Santa Catarina in a 10-hour overnight fast, following the protocols of dietary control and physical exercise in which they must maintain their usual pattern of exercises and food throughout the study, except for the restriction of the consumption of micronutrient food supplements, beverages with antioxidant and stimulating properties already known, such as green tea, black tea, and wines, which may interfere with the results of the study due to the similarity of bioactive compounds from yerba mate in the composition of these drinks. In all these visits in which there will be dietary intervention, the participants will assess their body composition and perform the exercise protocol to assess their performance.

In each of the three intervention visits, 60 minutes before the exercise protocol, a carbohydrate meal will be offered (for when the individual is randomized to the group in which this meal is consumed); 40 minutes before the exercise protocol, the infusion of yerba mate or water (250 mL) will be performed; immediately before the exercise protocol, blood will be collected from the intermediate vein of the arm to observe the increase in phenolics in the blood promoted by the ingestion of the yerba mate infusion. Soon after, it will be the realization of the effective exercise protocol to measure performance. During the execution of the exercise protocol, blood samples will be collected from the earlobe to check the variations of lactate and glucose. At the end of the exercise protocol, a new blood collection will be performed in the middle vein of the arm to assess biochemical variations that may have been influenced after exercise.

Being tested
Yerba mate infusion, Carbohydrate meal
Keywords
Ilex paraguariensis, Yerba mate, Cycling, Ergogenic aids, Metabolism, Plant-based, Nutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yerba mate infusionOther

    Yerba mate infusion intervention is characterized by the consumption of the infusion of yerba mate for 7 days preceding the test, with consumption of the infusion right before the exercise protocol test, without consumption of a carbohydrate-based meal, keeping the individual fasted.

    Yerba mate and carbohydrate intervention is characterized by the consumption of the infusion of yerba mate for 7 days preceding the test, with consumption of a meal based on carbohydrate right before the exercise protocol test with another infusion of yerba mate.

  • Carbohydrate mealOther

    Carbohydrate meal intervention is characterized by the consumption of a carbohydrate-based meal right before the exercise protocol test, without consumption yerba mate infusion.

Study groups in NCT04642144
Study groupRoleWhat they receive
Yerba mate and carbohydrateExperimentalConsumption of yerba mate infusion and carbohydrate-based meal.
Receives: Other: Yerba mate infusion; Other: Carbohydrate meal
Yerba mate and fastingActive comparatorConsumption of yerba mate infusion and stay in a fasting state.
Receives: Other: Yerba mate infusion
Carbohydrate and waterActive comparatorCarbohydrate meal consumption and water intake.
Receives: Other: Carbohydrate meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Power (kilojoules)

    To analyze the effects of the infusion of yerba mate drink on potency.

    Measured: Pre and post test on cycle ergometer, through study completion, an average of 1 month.

Secondary outcomes (1)
  1. Oxygen Consumption (% VO2 max)

    To determine and compare the physiological responses regarding oxygen consumption with yerba mate consumption.

    Measured: During cycle ergometer test, through study completion, an average of 1 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2020
  2. Study start20 Nov 2020
  3. Primary completion5 Jan 2021
  4. Study completion21 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
A group with yerba mate infusion and carbohydrate meal, a group with only yerba mate infusion, and a group with water and carbohydrate. The washout period between treatments will be seven days
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642144
Sponsor's protocol ID
04545218.1.0000.0121
Status last verified
Mar 2021
First submitted
6 Nov 2020
Last updated
2 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individuals' data are limited to the creation of results only for the research that our group is proposing to develop, not considering the sharing of individual data, keeping them confidential.

Publications

  • Krolikowski TC, Borszcz FK, Panza VP, Bevilacqua LM, Nichele S, da Silva EL, Amboni RDMC, Guglielmo LGA, Phillips SM, de Lucas RD, Boaventura BCB. The Impact of Pre-Exercise Carbohydrate Meal on the Effects of Yerba Mate Drink on Metabolism, Performance, and Antioxidant Status in Trained Male Cyclists. Sports Med Open. 2022 Jul 16;8(1):93. doi: 10.1186/s40798-022-00482-3.

    PubMed 35841429

Questions about this trial

What is this clinical trial studying?

A study testing Yerba mate infusion and Carbohydrate meal in people with Sports Performance and Sports Nutritional Sciences, run by Universidade Federal de Santa Catarina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Power (kilojoules) (time frame: Pre and post test on cycle ergometer, through study completion, an average of 1 month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04642144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.

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