Clinical trial NCT06254170: Supplementation Performance And Exercise With Euterpe Edulis for Men's Enhancement
Official title: Effect of Supplementation With Euterpe Edulis on the Physical and Mental Performance of Healthy Men Subjecting to Physical Exercise
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical Trial
Keywords: Anti-inflammatory
Antioxidant
Euterpe edulis
Exercise
Juçara
Lead sponsor: University Vila Velha
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in mental capacity - Simple reaction psychomotor test
timeFrame: 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.
measure: Changes in mental capacity - Psychomotor test of reaction of choice
timeFrame: 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.
measure: Changes in the modulation of the inflammatory profile - Collection of blood samples and analysis of biomarkers
timeFrame: Blood samples will be collected 1 hour before the high-intensity strength exercise and 1 hour after.
measure: Changes in physical capacity - Dynamometer
timeFrame: 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.
measure: Changes in physical capacity - Jump tests
timeFrame: 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.
measure: Changes in physical capacity - Functional tests
timeFrame: 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.
measure: Changes in physical capacity - Muscular endurance test
timeFrame: 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:
measure: Subjective change in muscle strength - Subjective analysis of fatigue
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: University of Vila Velha
name: Denise Coutinho Endringer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Butcher 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.
citation: Cabarkapa 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.
citation: Cardoso 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.
citation: Carroll 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.
citation: Lee 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.
citation: Fang 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.
citation: Felzenszwalb 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.
citation: FRANCISCONI, 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.
citation: 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.
citation: Koumantakis 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.
citation: Laurindo 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.
citation: Martins 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.
citation: Martinez 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.
citation: Mendes 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.
citation: de Oliveira AA, Torres AG, Perrone D, Monteiro M. Effect of High Hydrostatic Pressure Processing on the Anthocyanins Content, Antioxidant Activity, Sensorial Acceptance and Stability of Jussara (Euterpe edulis) Juice. Foods. 2021 Sep 22;10(10):2246. doi: 10.3390/foods10102246.
citation: Cunha de Souza Pereira D, Dos Santos Gomes F, Valeriano Tonon R, Beres C, Maria Correa Cabral L. Towards chemical characterization and possible applications of jucara fruit: an approach to remove Euterpe edulis Martius from the extinction list. J Food Sci Technol. 2023 Feb;60(2):429-440. doi: 10.1007/s13197-021-05342-8. Epub 2022 Jan 21.
citation: Petersen AM, Pedersen BK. The anti-inflammatory effect of exercise. J Appl Physiol (1985). 2005 Apr;98(4):1154-62. doi: 10.1152/japplphysiol.00164.2004.
citation: PIETRO, P. F. et al. Efeito do consumo de açaí (Euterpe oleracea Mart.) e de juçara (Euterpe edulis Mart.) sobre biomarcadores metabólicos e de estresse oxidativo em indivíduos saudáveis: um ensaio clínico randomizado cruzado de 4 semanas. Clinical Nutrition, v. 41, n. 1, p. 264-265, 2022.
citation: Schulz M, da Silva Campelo Borges G, Gonzaga LV, Oliveira Costa AC, Fett R. Jucara fruit (Euterpe edulis Mart.): Sustainable exploitation of a source of bioactive compounds. Food Res Int. 2016 Nov;89(Pt 1):14-26. doi: 10.1016/j.foodres.2016.07.027. Epub 2016 Aug 3.
citation: Severinsen MCK, Pedersen BK. Muscle-Organ Crosstalk: The Emerging Roles of Myokines. Endocr Rev. 2020 Aug 1;41(4):594-609. doi: 10.1210/endrev/bnaa016.
citation: SHANLEY, P.; MEDINA, G. Frutíferas e plantas úteis na vida amazônica. 1. ed. Belém: Cifor, Imazon, 2005.
citation: da Silva W, Machado AS, Souza MA, Mello-Carpes PB, Carpes FP. Effect of green tea extract supplementation on exercise-induced delayed onset muscle soreness and muscular damage. Physiol Behav. 2018 Oct 1;194:77-82. doi: 10.1016/j.physbeh.2018.05.006. Epub 2018 May 7.
citation: Stankiewicz B, Cieslicka M, Mieszkowski J, Kochanowicz A, Niespodzinski B, Szwarc A, Waldzinski T, Reczkowicz J, Piskorska E, Petr M, Skarpanska-Stejnborn A, Antosiewicz J. Effect of Supplementation with Black Chokeberry (Aronia melanocarpa) Extract on Inflammatory Status and Selected Markers of Iron Metabolism in Young Football Players: A Randomized Double-Blind Trial. Nutrients. 2023 Feb 15;15(4):975. doi: 10.3390/nu15040975.
citation: Torre-Villalvazo I, Aleman-Escondrillas G, Valle-Rios R, Noriega LG. Protein intake and amino acid supplementation regulate exercise recovery and performance through the modulation of mTOR, AMPK, FGF21, and immunity. Nutr Res. 2019 Dec;72:1-17. doi: 10.1016/j.nutres.2019.06.006. Epub 2019 Jul 2.
citation: Tutakhail A, Nazari QA, Khabil S, Gardier A, Coudore F. Muscular and mitochondrial effects of long-term fluoxetine treatment in mice, combined with physical endurance exercise on treadmill. Life Sci. 2019 Sep 1;232:116508. doi: 10.1016/j.lfs.2019.05.064. Epub 2019 Jul 3.
citation: Vearrier D, Grundmann O. Clinical Pharmacology, Toxicity, and Abuse Potential of Opioids. J Clin Pharmacol. 2021 Aug;61 Suppl 2:S70-S88. doi: 10.1002/jcph.1923.
citation: Lv Z, Shi W, Zhang Q. Role of Essential Amino Acids in Age-Induced Bone Loss. Int J Mol Sci. 2022 Sep 24;23(19):11281. doi: 10.3390/ijms231911281.