Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players (Effect of KA-E)
Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players: A Randomised, Double-Blind, Placebo-Controlled Study
The purpose of this study is to evaluate the effects of KA-EX supplementation on recovery parameters in elite young football players. Athletes from the Udine Primavera team will be randomly assigned to receive either the KA-EX supplement or a sensory-matched placebo immediately following their training sessions for a period of two months.
The researchers will monitor heart rate variability (HRV) and sleep quality using Garmin wearable devices, and assess changes in body composition using Dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). The goal of the study is to determine if post-training KA-EX administration improves physiological recovery, sleep quality, and physical readiness in high-performance athletes during a competitive season.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background and Rationale: Post-exercise recovery is a critical determinant of performance and adaptation in high-level football players. Insufficient recovery can lead to decreased physical readiness and increased risk of injury. KA-EX is a nutritional supplement containing a complex of amino acids, electrolytes, and functional sugars designed to support metabolic and physiological recovery. This study aims to investigate its efficacy in a real-world elite training environment.
Study Objectives: The primary objective is to evaluate the effect of KA-EX supplementation on physiological recovery parameters (HRV). Secondary objectives include assessing the impact on sleep recovery indices, changes in body composition (via DEXA), and cellular health parameters (via BIA).
Methodology and Design: This is an experimental, randomized, double-blind, placebo-controlled study.
Participants: 25 male players from the Udine Primavera team (Italy). Intervention: Participants will be randomly assigned to an experimental group (KA-EX) or a control group (placebo). The products will be identical in appearance, taste, and packaging to ensure blinding.
Duration: The intervention will last for 2 months, typically following the pre-season period.
Procedures:
Baseline Assessment: Participants will undergo initial DEXA scans, bioelectrical impedance analysis (BIA 101), and anthropometric measurements. Monitoring with Garmin devices will be initiated.
Intervention Phase: Supplements or placebos will be administered immediately after every training session. Recovery variables (HRV and sleep) will be continuously monitored using Garmin algorithms.
Final Assessment: At the end of the 2-month period, DEXA, BIA, and anthropometric measurements will be repeated to evaluate longitudinal changes.
Statistical Analysis: Within-group and between-group differences will be analyzed to compare the magnitude of change from baseline to post-intervention. Temporal evolution of recovery metrics throughout the 8-week period will also be assessed.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Francisco J. Berral de la Rosa, PhD
- Telefonnummer: +34672781737
- E-mail: nutrifarma@centrosnutrifarma.es
Studiesteder
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Friuli Venecia
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Udine, Friuli Venecia, Italien, 3310'
- Stadio BlueEnergy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Membership of the Udine Primavera team at the time of the study. Regular participation in the training programme during the intervention period (September).
Provision of written informed consent to participate in the study. Willingness to use a Garmin wearable device for continuous monitoring of recovery variables.
Exclusion Criteria:
- Presence of any injury or medical condition that limits normal participation in team training sessions.
Use of any other recovery supplements or ergogenic aids outside of the study protocol during the intervention period.
Failure to comply with the daily supplementation protocol or the scheduled assessment sessions (DEXA/BIA).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: KA-EX Group y Placebo Group.
Participants in this arm will receive the KA-EX supplement immediately after each training session during the 2-month intervention period.
KA-EX is a dietary supplement containing a complex of amino acids, electrolytes and functional sugars designed to support physiological recovery.
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Powder sachet to be dissolved in water.
Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.
Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.
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Placebo komparator: Placebo Group.
Participants in this arm will receive a placebo supplement immediately after each training session during the 2-month intervention period.
The placebo is organoleptically identical to the experimental supplement in terms of appearance, taste, texture and packaging to ensure double-blinding.
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Powder sachet to be dissolved in water.
Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.
Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Heart Rate Variability (rMSSD)
Tidsramme: Baseline and daily for 8 weeks.
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Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices.
Higher values indicate better parasympathetic recovery.
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Baseline and daily for 8 weeks.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Sleep Score
Tidsramme: Daily for 8 weeks.
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Overall sleep quality score calculated by Garmin's proprietary algorithm based on sleep duration, REM, and deep sleep cycles.
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Daily for 8 weeks.
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Change from Baseline in Recovery Readiness Index
Tidsramme: Daily for 8 weeks.
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Daily readiness score (Body Battery) obtained via Garmin wearable algorithm.
Scores range from 0 to 100; higher scores indicate greater physical readiness for training.
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Daily for 8 weeks.
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Body Composition
Tidsramme: 8 weeks.
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Body composition assessed at week 8. Lower values indicate reduction
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8 weeks.
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- ClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.
- International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UPO-KAEX-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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