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

NCT06254170 | Unknown DMC

• 2 other identifiers: T015M02-2024MS0046.202.888
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Clinical Trial

Keywords

Anti-inflammatory; Antioxidant; Euterpe edulis; Exercise; Juçara

Outcome Measures

Primary Outcomes (7)

• Changes in mental capacity - Simple reaction psychomotor test

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Subjective change in muscle strength - Subjective analysis of fatigue

  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.

Study Arms (2)

Euterpe Edulis suplementation

EXPERIMENTAL

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; Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

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; Dietary Supplement: Placebo

Interventions

Euterpe Edulis juice DIETARY_SUPPLEMENT

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.

Also known as: Juçara juice

Euterpe Edulis suplementation; Placebo

Placebo DIETARY_SUPPLEMENT

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.

Euterpe Edulis suplementation; Placebo

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Vila Velha: lead

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Related Links

• IBF - Instituto Brasileiro de florestas. Árvores brasileiras. 2020. Disponível em: https://www.ibflorestas.org.br/lista-de-especies-nativas/palmito-jucara. Acesso em: 5 mai 2023.
• IBGE - Instituto Brasileiro de Geografia e Estatística. Censo agropecuário 2017: resultados definitivos. Censo agropecuário. 2017. Disponível em: https://biblioteca.ibge.gov.br/visualizacao/periodicos/3096/agro\_2017\_resultados\_definitivos.pdf. Acesso em:

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Denise Coutinho Endringer

  University of Vila Velha

  STUDY DIRECTOR

Central Study Contacts

Deuel Azolin da Silva

CONTACT

+ 55 27 98166-9697; dermazolin@gmail.com

Denise Coutinho Endringer

CONTACT

+55 27 99916-3366; endringe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: February 19, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 12, 2024

Record last verified: 2023-11