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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Francisco J. Berral de la Rosa, PhD
- Numer telefonu: +34672781737
- E-mail: nutrifarma@centrosnutrifarma.es
Lokalizacje studiów
-
-
Friuli Venecia
-
Udine, Friuli Venecia, Włochy, 3310'
- Stadio BlueEnergy
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
|
Komparator placebo: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from Baseline in Heart Rate Variability (rMSSD)
Ramy czasowe: Baseline and daily for 8 weeks.
|
Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices.
Higher values indicate better parasympathetic recovery.
|
Baseline and daily for 8 weeks.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from Baseline in Sleep Score
Ramy czasowe: Daily for 8 weeks.
|
Overall sleep quality score calculated by Garmin's proprietary algorithm based on sleep duration, REM, and deep sleep cycles.
|
Daily for 8 weeks.
|
|
Change from Baseline in Recovery Readiness Index
Ramy czasowe: Daily for 8 weeks.
|
Daily readiness score (Body Battery) obtained via Garmin wearable algorithm.
Scores range from 0 to 100; higher scores indicate greater physical readiness for training.
|
Daily for 8 weeks.
|
|
Body Composition
Ramy czasowe: 8 weeks.
|
Body composition assessed at week 8. Lower values indicate reduction
|
8 weeks.
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- ClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.
- International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UPO-KAEX-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .