Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04642144 |
| Other study ID # |
04545218.1.0000.0121 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2020 |
| Est. completion date |
January 21, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Universidade Federal de Santa Catarina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
