- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07584460
Juçara (Euterpe Edulis Martius) Supplementation Effect in Muscle Protection, Performance and Soreness in Lower Limbs After Exercise-Induced Muscle Damage
Juçara (Euterpe Edulis Martius) Supplementation Effect in Muscle Protection, Performance and Soreness in Lower Limbs After Exercise-Induced Muscle Damage: A Six-Week Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
The purpose of this study is to find out if taking a natural supplement made from the Juçara fruit (a Brazilian berry rich in antioxidants called anthocyanins) can help the body recover faster after damage caused by exercise. Researchers want to see if Juçara can reduce muscle soreness and help muscles regain their strength and quality more quickly compared to a placebo (a "dummy" pill with no active ingredients).
What happens during the study? The study included 24 healthy, active men. It was a "crossover" study, meaning every participant tried both the Juçara supplement and the placebo at different times.
Supplement Phase: Participants took 12 capsules a day for 7 days.
Muscle Damage Test: To cause temporary muscle damage, participants performed a specific jumping protocol (100 maximal jumps).
Recovery Monitoring: Researchers tracked the participants for 72 hours after the jumps to measure:
How high they could jump (strength/performance).
Muscle soreness (using a pain scale).
Muscle "quality" and stiffness (using ultrasound imaging).
Wait Period: After the first phase, participants waited 14 days (washout) before switching to the other supplement to repeat the process.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Rio Grande do Sul
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Santa Maria, Rio Grande do Sul, Brésil, 97105900
- Centro de Educação Física e Desportos
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Males
- Aged 18-40 years
- Physically active, defined as performing at least three exercise sessions per week according to IPAQ questionnaire
- No history at lower-limb within the previous six months
- No medical restrictions for maximal exercise testing
- No allergy to red fruits
- No physical, cognitive and/or psychological limitations affecting the execution or understanding of the protocol
- No history of lower-limb surgery
- No use nutritional supplements within 30 days prior to study initiation
- Abstention from caffeine, cacao, yerba mate tea, and soft drinks during the study protocol.
Exclusion Criteria:
- Individuals younger than 18 or older than 40 years
- Not physically active, defined as performing fewer than three exercise sessions per week according to IPAQ questionnaire
- Presence of history at lower-limb injury within the previous six months
- Presence of medical restrictions for maximal exercise testing
- Known allergy to red fruits
- Presence of physical, cognitive and/or psychological limitations affecting the execution or understanding of the protocol
- History of lower-limb surgery
- Use of nutritional supplements within 30 days prior to study initiation
- Inability to abstain from caffeine, cacao, yerba mate tea, and soft drinks during the study protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Juçara group
The sample consisted of 24 healthy, physically active men with any kind of experience in any physical exercise modality.
Eligibility criteria were as follows: (1) male, aged 18-40 years; (2) physically active, defined as performing at least three exercise sessions per week according to IPAQ questionnaire; (3) no history at lower-limb within the previous six months; (4) no medical restrictions for maximal exercise testing; (5) no allergy to red fruits; (6) no physical, cognitive and/or psychological limitations affecting the execution or understanding of the protocol; (7) no history of lower-limb surgery; (8) no use nutritional supplements within 30 days prior to study initiation; and (9) abstention from caffeine, cacao, yerba mate tea, and soft drinks during the study protocol.
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Total of 11 separate occasions under the Juçara condition.
A familiarization session of CMJ and EIMD protocol (10 sets of CMJ repetitions with 1-minute rest between sets) was performed, followed by a 14-day washout period.
During this visit, volunteers' descriptive data were assessed.
On day 1 of this condition (72h pre EIMD), body mass was obtained, and participants received the supplementation (Juçara) to be consumed for 7 days (one capsule every 12 h).
On day 2, the CSA from QUAD and HAMS, elastography from vastus lateralis (VL) and biceps femoris long head (BFlh) of the dominant limb, and the CMJ performance were assessed.
After that, participants performed the EIMD protocol.
Follow-up assessments were conducted at 24 h (day 3), 48 h (day 4), and 72 h (day 5) post-EIMD, repeating the same measurements.
A 14-day washout period separated the two interventions.
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Comparateur placebo: Placebo Group
The sample consisted of 24 healthy, physically active men with any kind of experience in any physical exercise modality.
Eligibility criteria were as follows: (1) male, aged 18-40 years; (2) physically active, defined as performing at least three exercise sessions per week according to IPAQ questionnaire; (3) no history at lower-limb within the previous six months; (4) no medical restrictions for maximal exercise testing; (5) no allergy to red fruits; (6) no physical, cognitive and/or psychological limitations affecting the execution or understanding of the protocol; (7) no history of lower-limb surgery; (8) no use nutritional supplements within 30 days prior to study initiation; and (9) abstention from caffeine, cacao, yerba mate tea, and soft drinks during the study protocol.
|
Total of 11 separate occasions under the placebo condition.
A familiarization session of CMJ and EIMD protocol (10 sets of CMJ repetitions with 1-minute rest between sets) was performed, followed by a 14-day washout period.
During this visit, volunteers' descriptive data were assessed.
On day 1 of this condition (72h pre EIMD), body mass was obtained, and participants received the supplementation (placebo) to be consumed for 7 days (one capsule every 12 h).
On day 2, the CSA from QUAD and HAMS, elastography from vastus lateralis (VL) and biceps femoris long head (BFlh) of the dominant limb, and the CMJ performance were assessed.
After that, participants performed the EIMD protocol.
Follow-up assessments were conducted at 24 h (day 3), 48 h (day 4), and 72 h (day 5) post-EIMD, repeating the same measurements.
A 14-day washout period separated the two interventions.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Countermovement Jump Height
Délai: From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Countermovement Jump (CMJ) hieght will be measured to assess using two force plates (AMTI OR6-6-2000; 1000 Hz).
Measurements will be obtained at Baseline (Pre), and at 24, 48, and 72 hours following the exercise induced muscle damage (EIMD) protocol.
Data will be expressed in centimeters (cm).
Jump height will be calculated using take-off velocity and projectile motion principles.
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From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Contermovement jump power
Délai: From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Countermovement Jump (CMJ) power will be evaluated using two force plates (AMTI OR6-6-2000; 1000 Hz).
Peak power will be calculated based on the jump flight time or force-time curve.
Assessments will be performed at Baseline (Pre), 24h, 48h, and 72h post exercise induced muscle damage.
Data will be expressed in Watts (W).
Power during the concentric phase (i.e., the propulsive phase; interval between the onset of propulsion and take-off) will be calculated by multiplying force by velocity.
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From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Quadriceps and hamstrings Echointensity
Délai: From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Quadriceps and Hamstrings muscle echointensity will be assessed using ultrasonography to evaluate muscle damage.
Images will be analyzed through gray-scale histogram analysis using ImageJ software.
Assessments will be performed at Baseline (Pre-exercise), and at 24 hours, 48 hours, and 72 hours following the exercise-induced muscle damage (EIMD) protocol.
Data will be expressed in arbitrary units (AU).
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From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Quadriceps and Hamstrings Cross-Sectional Area
Délai: From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol
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Muscle Cross-Sectional Area from Quadriceps and Hamstrings will be assessed using an ultrasound with extended field of view mode at 50% of limb length.
Quadriceps and Hamstrings Cros-Sectional areas will be expressed in cm².
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From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol
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Vastus Lateralis and Biceps Femoris Long Head stiffness
Délai: From pre Exercise Muscle Damage Protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Vastus Lateralis and Biceps Femoris Long Head muscle stiffness will be assessed using Shear Wave Elastography mode from an ultrasound.
Muscle stiffness will be expressed in kilopascal (kPa).
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From pre Exercise Muscle Damage Protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Quadriceps and Hamstrings muscle soreness
Délai: From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Muscle soreness of the quadriceps will be assessed using a Visual Analogue Scale (VAS).
Measurements will be obtained at Baseline (Pre-exercise), Immediately Post-exercise, 24 hours, 48 hours, and 72 hours following the Exercise Induced Muscle Damage (EIMD) protocol.
Data will be expressed on a scale from 0 (no soreness) to 30 centimeters (worst possible soreness).
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From pre Exercise Induced Muscle Damage protocol to Post-72h Exercise Induced Muscle Damage protocol.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 6.753.984
- UFSM (Autre identifiant: UFSM)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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