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

U

University Vila Velha

Status

Not yet enrolling

Conditions

Clinical Trial

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Euterpe Edulis juice

Study type

Interventional

Funder types

Other

Identifiers

NCT06254170
T015M02-2024MS004
6.202.888 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Male

Ages

19 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups, including a placebo group

Euterpe Edulis suplementation
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Placebo
Dietary Supplement: Euterpe Edulis juice
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Dietary Supplement: Placebo
Dietary Supplement: Euterpe Edulis juice

Trial documents
2

Trial contacts and locations

0

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Central trial contact

Denise Coutinho Endringer; Deuel Azolin da Silva

Data sourced from clinicaltrials.gov

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