Supplementation Performance And Exercise With Euterpe Edulis for Men's Enhancement (SPAEME)

February 2, 2024 updated by: University Vila Velha

Effect of Supplementation With Euterpe Edulis on the Physical and Mental Performance of Healthy Men Subjecting to Physical Exercise

The study aims to evaluate the effect of supplementation with Euterpe edulis on the physical and mental performance, inflammation, muscle recovery, and muscle strength of healthy men submitted to physical exercises. The study will use a double-blind and randomized design, including physical tests, blood sample analysis, and subjective assessments. Participants will receive 250 ml of the juice or a placebo for ten days before the evaluations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Euterpe edulis palm, known as juçara, produces spherical and purple fruits, similar to those of the Euterpe oleracea and Euterpe precatoria palms, from where the popular name açaí originates. The juçara fruit has been gaining prominence in the scientific world for its interesting nutritional composition, rich in antioxidants, and for its sustainable production model. Intermittent high-intensity exercise (HIIE) can improve the anti-inflammatory state. Juçara juice (JFJ) has well-established antioxidant and anti-inflammatory properties. Recently, relevant biological activities have been associated with the fruit of the juçara, and its use in food has become an important nutritional, environmental and economic alternative. The objective of this project is to evaluate the antioxidant and anti-inflammatory effects of E. edulis juice after physical exercise in physical activity practitioners. This is a clinical trial, double blind, where high intensity physical exercise will be used and evaluated simple reaction psychomotor test, psychomotor test of choice reaction, collection of blood samples for analysis of interleukins and TNF alpha, strength markers, through the use of dynamometer, jump test, functional tests, muscle endurance test and subjective analysis of fatigue. The selection will be simple random probabilistic according to the inclusion criteria: male gender, aged between 19 and 30 years and practitioners of physical activity for at least 3 months 4 x per week, without comorbidities, non-athlete, non-smokers, and BMI < 30. Participants will receive 250 ml of the juice or placebo during 10 days of previous treatment, maintaining the exercise routine. The aminogram of JFJ (250 ml) will be evaluated to understand the amount of essential amino acids and the possibility of classifying the Juçara fruit as a super fruit. It is expected, after supplementation with the aqueous extract of E. edulis, improvement in the physical and mental capacity of the sample that used the JFJ, in addition to a better response in plasma inflammatory biomarkers and antioxidant capacity, resulting in a positive modulation of the inflammatory profile. In addition, we consider an optimization in muscle recovery capacity and objective and subjective increase in muscle strength as an outcome.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Denise Coutinho Endringer
  • Phone Number: +55 27 99916-3366
  • Email: endringe@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men aged 19 to 30 years, who perform regular physical exercises, in total of 150 min per week, at a minimum of 3 months

Exclusion Criteria:

  • Men who use steroids, anabolics, taurine, BCCA, and exogenous supplementation will be excluded.
  • People who have motor problems, cardiovascular changes, have type I and II diabetes, smokers, athletes, cognitive deficits, and psychomotor disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Euterpe Edulis suplementation
Male, aged between 19 and 30 years and practicing physical exercises regularly for at least 3 months will receive the Euterpe Edulis juice for 10 days.
Dietary supplement: Euterpe Edulis juice
The preparation will be obtained with the same methods already well established in previous studies (SCHULZ et al., 2016.; MENDES et al., 2021). Participants will receive commercial samples of juçara (E.edulis) refrigerated to 4°C to 10°C, per day, for 10 days, and on the 11th will be the exercise and on this day will be administered the juice of the juçara 2 h before on the day of the monitored exercise. The chemical characterization of Euterpe edulis will be with at least 350.0 + or - 17.5 mg of total phenolics (gallic acid equivalent), 186.0 + or - 7.5 mg of total monomeric anthocyanins (cyanidin 3-glycoside), 0.73 + or less 0.01 g of proteins, and 2.75 + or - 0.03 g of lipids (ether extract). During the 10 days of previous treatment, maintain the routine of physical exercises.
Other Names:
  • Juçara juice
Dietary supplement: Placebo
Participants will receive 250 ml of water + purple dye + pectin (control) refrigerated to 4°C to 10°C, per day, for 10 days, and on the 11th will be the exercise and on this day will be administered the juice of the juçara 2 h before on the day of the monitored exercise. The chemical characterization of Euterpe edulis will be with at least 350.0 + or - 17.5 mg of total phenolics (gallic acid equivalent), 186.0 + or - 7.5 mg of total monomeric anthocyanins (cyanidin 3-glycoside), 0.73 + or less 0.01 g of proteins, and 2.75 + or - 0.03 g of lipids (ether extract). During the 10 days of previous treatment, maintain the routine of physical exercises.
Placebo Comparator: Placebo
Male, aged between 19 and 30 years and practicing physical exercises regularly for at least 3 months will receive the placebo product for 10 days.
Dietary supplement: Euterpe Edulis juice
The preparation will be obtained with the same methods already well established in previous studies (SCHULZ et al., 2016.; MENDES et al., 2021). Participants will receive commercial samples of juçara (E.edulis) refrigerated to 4°C to 10°C, per day, for 10 days, and on the 11th will be the exercise and on this day will be administered the juice of the juçara 2 h before on the day of the monitored exercise. The chemical characterization of Euterpe edulis will be with at least 350.0 + or - 17.5 mg of total phenolics (gallic acid equivalent), 186.0 + or - 7.5 mg of total monomeric anthocyanins (cyanidin 3-glycoside), 0.73 + or less 0.01 g of proteins, and 2.75 + or - 0.03 g of lipids (ether extract). During the 10 days of previous treatment, maintain the routine of physical exercises.
Other Names:
  • Juçara juice
Dietary supplement: Placebo
Participants will receive 250 ml of water + purple dye + pectin (control) refrigerated to 4°C to 10°C, per day, for 10 days, and on the 11th will be the exercise and on this day will be administered the juice of the juçara 2 h before on the day of the monitored exercise. The chemical characterization of Euterpe edulis will be with at least 350.0 + or - 17.5 mg of total phenolics (gallic acid equivalent), 186.0 + or - 7.5 mg of total monomeric anthocyanins (cyanidin 3-glycoside), 0.73 + or less 0.01 g of proteins, and 2.75 + or - 0.03 g of lipids (ether extract). During the 10 days of previous treatment, maintain the routine of physical exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mental capacity - Simple reaction psychomotor test
Time Frame: The test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
The examined individual should sit in front of the monitor with the index finger of the dominant hand positioned on the sensor (called the ''stand-by key'') located on the control panel. The individual will be instructed to hold their finger on the ''stand-by key'' and move it to the ''reaction key'' as soon as the stimulus (yellow light) appears.
The test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Changes in mental capacity - Psychomotor test of reaction of choice
Time Frame: The test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.

One individual was instructed to respond appropriately and as quickly as possible to stimuli appearing on the screen using the upper and lower limbs.

Five colored optical stimuli (white, yellow, blue, green, and red) in the form of a circle appeared on the screen, and each circle received its own ''reaction key'' on the control panel that corresponded to the color of the stimulus.

The examined individual was asked to respond to the stimulus by pressing the corresponding ''reaction key'' with the right or left hand, and the foot was also instructed to press the right or left pedal whenever a white rectangular light appeared on the black background of the screen. Finally, the test included reaction to acoustic stimuli.
The test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Changes in the modulation of the inflammatory profile - Collection of blood samples and analysis of biomarkers
Time Frame: Blood samples will be collected 1 hour before the high-intensity strength exercise and 1 hour after.
Will be evaluated in the blood samples collected: plasma biomarkers, which include lactate concentration (LA). In plasma, creatine kinase (CK), total antioxidant capacity (TAC) and concentrations of testosterone (T), cortisol © and growth hormone (GH) will be analyzed. In addition to serum concentrations of inflammatory biomarkers such as interleukins (IL-6, IL-8, IL10) and TNF-alpha.
Blood samples will be collected 1 hour before the high-intensity strength exercise and 1 hour after.
Changes in physical capacity - Dynamometer
Time Frame: The dynamometer will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
The dynamometer is an instrument used to measure muscle strength objectively. In this study will be used the static dynamometer that demonstrated measurement reliability in other clinical trials (HIRANO et al., 2020; MARTINS et al., 2018).
The dynamometer will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Changes in physical capacity - Jump tests
Time Frame: The jump tests will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
The jump tests are used as a measure of explosive strength and muscle power and this methodology will also be used in this research. The effectiveness of strength assessment in the countermovement jump test has already been validated in other clinical studies (CARBAKAPA et al., 2023).
The jump tests will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Changes in physical capacity - Functional tests
Time Frame: The 6-minute step test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Functional tests assess strength in more complex movements related to day-to-day activities. In these studies, the 6-minute step test will be applied, as determined its reliability for the evaluation of muscle strength in a previous study (ARCURI et al., 2016).
The 6-minute step test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Changes in physical capacity - Muscular endurance test
Time Frame: The abdominal resistance test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.
Muscle endurance tests assess the ability of muscles to sustain a contraction for a prolonged period. In this study will be used the abdominal resistance test, through the plank test, already reproduced effectively in another study (KOUMANTAKIS et al., 2021).
The abdominal resistance test will be applied on day 1 and 11 of the study, after the period of 10 days drinking Juçara juice. The same methodology will be used in the patients who received the placebo product.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective change in muscle strength - Subjective analysis of fatigue
Time Frame: The questionnaire will be applied on day 11 of the study, after the period of 10 days drinking Juçara juice and the force tests. The same methodology will be used in the patients who received the placebo product.
A questionnaire will be developed about the subjective perception of patients about the effects of the treatment employed in the recovery of muscle fatigue. The questions will be based on the Chalder scale and the International Short-Form Physical Activity Questionnaire (IPAQ-SF) (LEE et al., 2011). However, the feeling of improvement or not of physical fatigue after exercise will be the focus of the preparation of a new and unprecedented questionnaire.
The questionnaire will be applied on day 11 of the study, after the period of 10 days drinking Juçara juice and the force tests. The same methodology will be used in the patients who received the placebo product.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Vila Velha

Investigators

  • Study Director: Denise Coutinho Endringer, University of Vila Velha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T015M02-2024MS004
  • 6.202.888 (Registry Identifier: Plataforma Brasil)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clinical Trial

Clinical Trials on Euterpe Edulis juice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe