Clinical TrialSPAEMENCT06254170
Supplementation Performance And Exercise With Euterpe Edulis for Men's Enhancement
A study testing Euterpe Edulis juice in people with Clinical Trial, run by University Vila Velha.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial
- What is being tested?
- Euterpe Edulis juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2024to 30 Aug 2024
- 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 19 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 19 to 30 years, who perform regular physical exercises, in total of 150 min per week, at a minimum of 3 months
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Clinical Trial
- Being tested
- Euterpe Edulis juice, Placebo
- Keywords
- Anti-inflammatory, Antioxidant, Euterpe edulis, Exercise, Juçara
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euterpe Edulis juiceDietary supplement
Also called Juçara 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Euterpe Edulis juice; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start19 Feb 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Vila Velha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Coutinho Endringer, Study director, University of Vila Velha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254170
- Sponsor's protocol ID
- T015M02-2024MS004
- Other IDs
- 6.202.888
- Acronym
- SPAEME
- Status last verified
- Nov 2023
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.
PubMed 25706661Butcher JT, Ali MI, Ma MW, McCarthy CG, Islam BN, Fox LG, Mintz JD, Larion S, Fulton DJ, Stepp DW. Effect of myostatin deletion on cardiac and microvascular function. Physiol Rep. 2017 Dec;5(23):e13525. doi: 10.14814/phy2.13525.
PubMed 29192067Cabarkapa D, Philipp NM, Cabarkapa DV, Fry AC. Position-specific differences in countermovement vertical jump force-time metrics in professional male basketball players. Front Sports Act Living. 2023 Jul 20;5:1218234. doi: 10.3389/fspor.2023.1218234. eCollection 2023.
PubMed 37547821Cardoso AL, de Liz S, Rieger DK, Farah ACA, Kunradi Vieira FG, Altenburg de Assis MA, Di Pietro PF. An Update on the Biological Activities of Euterpe edulis (Jucara). Planta Med. 2018 May;84(8):487-499. doi: 10.1055/s-0044-101624. Epub 2018 Feb 21.
PubMed 29466809Carroll TJ, Taylor JL, Gandevia SC. Recovery of central and peripheral neuromuscular fatigue after exercise. J Appl Physiol (1985). 2017 May 1;122(5):1068-1076. doi: 10.1152/japplphysiol.00775.2016. Epub 2016 Dec 8.
PubMed 27932676Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PubMed 22018588Fang P, She Y, Yu M, Min W, Shang W, Zhang Z. Adipose-Muscle crosstalk in age-related metabolic disorders: The emerging roles of adipo-myokines. Ageing Res Rev. 2023 Feb;84:101829. doi: 10.1016/j.arr.2022.101829. Epub 2022 Dec 20.
PubMed 36563906Felzenszwalb I, da Costa Marques MR, Mazzei JL, Aiub CA. Toxicological evaluation of Euterpe edulis: a potential superfruit to be considered. Food Chem Toxicol. 2013 Aug;58:536-44. doi: 10.1016/j.fct.2013.05.029. Epub 2013 May 24.
PubMed 23712094FRANCISCONI, A. F. et al. Genomas completos de cloroplastos e filogenia em três palmeiras Euterpe (E. edulis, E. oleracea e E. precatoria) de diferentes biomas brasileiros. PLoS One, v. 17, n. 7, e0266304, 2022.
Hirano M, Katoh M, Gomi M, Arai S. Validity and reliability of isometric knee extension muscle strength measurements using a belt-stabilized hand-held dynamometer: a comparison with the measurement using an isokinetic dynamometer in a sitting posture. J Phys Ther Sci. 2020 Feb;32(2):120-124. doi: 10.1589/jpts.32.120. Epub 2020 Feb 14.
PubMed 32158074Koumantakis GA, Malkotsis A, Pappas S, Manetta M, Anastopoulos T, Kakouris A, Kiourtsidakis E. Lumbopelvic sagittal standing posture associations with anthropometry, physical activity levels and trunk muscle endurance in healthy adults. Hong Kong Physiother J. 2021 Dec;41(2):127-137. doi: 10.1142/S1013702521500128. Epub 2021 May 4.
PubMed 34177201Laurindo LF, Barbalho SM, Araujo AC, Guiguer EL, Mondal A, Bachtel G, Bishayee A. Acai (Euterpe oleracea Mart.) in Health and Disease: A Critical Review. Nutrients. 2023 Feb 16;15(4):989. doi: 10.3390/nu15040989.
PubMed 36839349Martins J, da Silva JR, da Silva MRB, Bevilaqua-Grossi D. Reliability and Validity of the Belt-Stabilized Handheld Dynamometer in Hip- and Knee-Strength Tests. J Athl Train. 2017 Sep;52(9):809-819. doi: 10.4085/1062-6050-52.6.04. Epub 2017 Aug 8.
PubMed 28787180Martinez Martin A, Perez Herrero M, Sanchez Quiros B, Lopez Herrero R, Ruiz Bueno P, Cocho Crespo S. [Translated article] Benefits of analgesic blocks, PENG block (PEricapsular Nerve Group), in fast recovery after hip surgery. Rev Esp Cir Ortop Traumatol. 2023 Jan-Feb;67(1):T27-T34. doi: 10.1016/j.recot.2022.10.005. Epub 2022 Oct 13. English, Spanish.
PubMed 36243392Mendes BC, Copetti CLK, Panza VSP, Orssatto LBR, da Rosa JS, Diefenthaeler F, Dalmarco EM, Pietro PFD, Rieger DK. Effects of Euterpe edulis Martius on inflammatory responses to high-intensity intermittent exercise: Crossover randomized trial. Nutrition. 2021 Nov-Dec;91-92:111344. doi: 10.1016/j.nut.2021.111344. Epub 2021 May 28.
PubMed 34273682
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With Euterpe Edulis on the Physical and Mental Performance of Healthy Men Subjecting to Physical Exercise
- ClinicalTrials.gov ID
- NCT06254170
- Acronym / sponsor ID
- SPAEME / T015M02-2024MS004
- Conditions
- Clinical Trial
- Keywords
- Anti-inflammatory, Antioxidant, Euterpe edulis, Exercise, Juçara
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Vila VelhaUniversity, hospital or other
- Study start
- 19 Feb 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euterpe Edulis suplementation | Experimental | Dietary Supplement: Euterpe Edulis juice, Dietary Supplement: PlaceboMale, 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. |
| Placebo | Placebo comparator | Dietary Supplement: Euterpe Edulis juice, Dietary Supplement: PlaceboMale, aged between 19 and 30 years and practicing physical exercises regularly for at least 3 months will receive the placebo product for 10 days. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men aged 19 to 30 years, who perform regular physical exercises, in total of 150 min per week, at a minimum of 3 months
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Euterpe Edulis juiceAlso: Juçara juiceThe 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. | Dietary supplement | Euterpe Edulis suplementation, Placebo |
| PlaceboParticipants 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. | Dietary supplement | Euterpe Edulis suplementation, Placebo |
Primary outcome
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.
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.
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.
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).
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).
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).
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).
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 25706661Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.
- Background: PubMed 29192067Butcher JT, Ali MI, Ma MW, McCarthy CG, Islam BN, Fox LG, Mintz JD, Larion S, Fulton DJ, Stepp DW. Effect of myostatin deletion on cardiac and microvascular function. Physiol Rep. 2017 Dec;5(23):e13525. doi: 10.14814/phy2.13525.
- Background: PubMed 37547821Cabarkapa D, Philipp NM, Cabarkapa DV, Fry AC. Position-specific differences in countermovement vertical jump force-time metrics in professional male basketball players. Front Sports Act Living. 2023 Jul 20;5:1218234. doi: 10.3389/fspor.2023.1218234. eCollection 2023.
- Background: PubMed 29466809Cardoso AL, de Liz S, Rieger DK, Farah ACA, Kunradi Vieira FG, Altenburg de Assis MA, Di Pietro PF. An Update on the Biological Activities of Euterpe edulis (Jucara). Planta Med. 2018 May;84(8):487-499. doi: 10.1055/s-0044-101624. Epub 2018 Feb 21.
- Background: PubMed 27932676Carroll TJ, Taylor JL, Gandevia SC. Recovery of central and peripheral neuromuscular fatigue after exercise. J Appl Physiol (1985). 2017 May 1;122(5):1068-1076. doi: 10.1152/japplphysiol.00775.2016. Epub 2016 Dec 8.
- Background: PubMed 22018588Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
- Background: PubMed 36563906Fang P, She Y, Yu M, Min W, Shang W, Zhang Z. Adipose-Muscle crosstalk in age-related metabolic disorders: The emerging roles of adipo-myokines. Ageing Res Rev. 2023 Feb;84:101829. doi: 10.1016/j.arr.2022.101829. Epub 2022 Dec 20.
- Background: PubMed 23712094Felzenszwalb I, da Costa Marques MR, Mazzei JL, Aiub CA. Toxicological evaluation of Euterpe edulis: a potential superfruit to be considered. Food Chem Toxicol. 2013 Aug;58:536-44. doi: 10.1016/j.fct.2013.05.029. Epub 2013 May 24.
- BackgroundFRANCISCONI, A. F. et al. Genomas completos de cloroplastos e filogenia em três palmeiras Euterpe (E. edulis, E. oleracea e E. precatoria) de diferentes biomas brasileiros. PLoS One, v. 17, n. 7, e0266304, 2022.
- Background: PubMed 32158074Hirano M, Katoh M, Gomi M, Arai S. Validity and reliability of isometric knee extension muscle strength measurements using a belt-stabilized hand-held dynamometer: a comparison with the measurement using an isokinetic dynamometer in a sitting posture. J Phys Ther Sci. 2020 Feb;32(2):120-124. doi: 10.1589/jpts.32.120. Epub 2020 Feb 14.
- Background: PubMed 34177201Koumantakis GA, Malkotsis A, Pappas S, Manetta M, Anastopoulos T, Kakouris A, Kiourtsidakis E. Lumbopelvic sagittal standing posture associations with anthropometry, physical activity levels and trunk muscle endurance in healthy adults. Hong Kong Physiother J. 2021 Dec;41(2):127-137. doi: 10.1142/S1013702521500128. Epub 2021 May 4.
- Background: PubMed 36839349Laurindo LF, Barbalho SM, Araujo AC, Guiguer EL, Mondal A, Bachtel G, Bishayee A. Acai (Euterpe oleracea Mart.) in Health and Disease: A Critical Review. Nutrients. 2023 Feb 16;15(4):989. doi: 10.3390/nu15040989.
- 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.Link provided by the sponsor.
- 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:Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Coutinho Endringer study director
University of Vila Velha
Questions about this trial
What is this clinical trial studying?
A study testing Euterpe Edulis juice in people with Clinical Trial, run by University Vila Velha.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deuel Azolin da Silva (+ 55 27 98166-9697, dermazolin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. 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 NCT06254170, which also lists 28 linked publications.
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 12 Feb 2024.