- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07714057
Effect of Hydrogen-rich Water During Tapering on Recovery After Functional Overreaching in Basketball Players
Effect of Hydrogen-rich Water Supplementation During Tapering on Recovery After Functional Overreaching in Competitive Male Basketball Players: A Randomized, Double-blind, Placebo-controlled Paralel-group Trial
The goal of this clinical trial is to evaluate whether hydrogen-rich water supplementation during tapering improves recovery after functional overreaching in competitive male basketball players aged 18-35 years. The main questions it aims to answer are:
- Does hydrogen-rich water improve autonomic recovery after functional overreaching?
- Does hydrogen-rich water improve recovery in biochemical, performance, and subjective feeling outcomes during tapering?
Researchers will compare hydrogen-rich water to placebo (water containing no molecular hydrogen) to determine whether molecular hydrogen improves recovery after accumulated fatigue has been induced by functional overreaching. Participants will:
- Complete a training cycle including normal training, functional overreaching, and tapering.
- Consume hydrogen-rich or placebo water daily during the one-week tapering period.
- Undergo repeated testing of autonomic nervous system, blood biochemical markers, performance, and subjective soreness.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study consists of an initial screening and entry testing phase, followed by one week of normal training, two weeks of functional overreaching, and one week of tapering. During the functional overreaching period, training load is increased to approximately 120-130% of normal training load to induce accumulated fatigue. During the tapering period, training volume is reduced to approximately 50-60% of normal training volume to support recovery and performance rebound.
The molecular hydrogen is administered only during the tapering period. Participants in the experimental group consume 2.5 L per day of hydrogen-rich water. The total daily dose is divided into 0.5 L in the morning, 1.5 L around training, and 0.5 L in the evening. Participants in the placebo group consume visually matched placebo water according to the same total daily intake and timing schedule. Supplementation adherence is monitored using logs, dose counts, and attendance records. Participants are randomly assigned in a 1:1 ratio to either the experimental group or the placebo group. Randomization is performed using a block scheme and a computer random number generator.
Testing is performed at multiple time points: entry laboratory testing, baseline after normal training, post-functional overreaching, and post-taper. The primary interval for evaluation is the change from post-functional overreaching to post-taper. Statistical analysis is based on a t-test or analysis of variance. Data that not follow a normal distribution are treated using a logarithmic transformation or analyzed using nonparametric tests. The significance level is set at 0.05.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jakub Krejci, PhD
- Email: jakub.krejci@upol.cz
Backup dei contatti dello studio
- Nome: Jan Kvas
- Numero di telefono: +420774678756
- Email: jan.kvas01@upol.cz
Luoghi di studio
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Olomouc, Cechia, 77111
- Palacky University, Faculty of Physical Culture
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Contatto:
- Jan Kvas
- Numero di telefono: +420774678756
- Email: jan.kvas01@upol.cz
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Competitive male basketball players.
- Signed informed consent.
- Completion of entry medical and laboratory screening.
Exclusion Criteria:
- Acute injury or infection.
- History or presence of relevant cardiovascular, respiratory, metabolic, or other disease that may affect the study results.
- Use of medication affecting recovery markers or study results.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Hydrogen-rich water
Hydrogen-rich water administered at a dose of 2.5 L per day during a one-week tapering period.
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Hydrogen-rich water with molecular hydrogen concentration >1.0 ppm.
Altri nomi:
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Comparatore placebo: Placebo water
Placebo water administered at a dose of 2.5 L per day during a one-week tapering period.
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Tap water without molecular hydrogen.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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RMSSD
Lasso di tempo: One-week change between post-overreaching and post-taper.
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The root mean square of successive differences of RR intervals (RMSSD) is used as an index of parasympathetic activity and is calculated from an ECG using heart rate variability analysis.
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One-week change between post-overreaching and post-taper.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Creatine kinase
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood creatine kinase concentration is used as a marker of muscle damage.
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One-week change between post-overreaching and post-taper.
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High-sensitivity C-reactive protein
Lasso di tempo: One-week change between post-overreaching and post-taper.
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High-sensitivity C-reactive protein concentration is used as a marker of systemic inflammatory.
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One-week change between post-overreaching and post-taper.
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Cortisol
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood cortisol concentration is used as a marker of physiological stress response.
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One-week change between post-overreaching and post-taper.
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Testosterone
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood testosterone concentration is used as a marker related to anabolic-catabolic balance.
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One-week change between post-overreaching and post-taper.
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Urea
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood urea concentration is used as a marker related to metabolic and protein-turnover stress.
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One-week change between post-overreaching and post-taper.
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Leukocytes
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood leukocyte count is used as a marker of immune-related response to training.
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One-week change between post-overreaching and post-taper.
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Lymphocytes
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood lymphocyte count is used as a marker of immune-related response to training.
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One-week change between post-overreaching and post-taper.
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Neutrophils
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Blood lymphocyte count is used as a marker of imflammatory response to training.
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One-week change between post-overreaching and post-taper.
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Reactive strength index
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Reactive strength index is used as an marker of neuromuscular function of the lower limbs and is measured using a drop jump.
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One-week change between post-overreaching and post-taper.
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Hangrip test
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Handgrip test is used as a marker of forearm muscle strength and is measured using a dynamometer.
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One-week change between post-overreaching and post-taper.
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20-m sprint
Lasso di tempo: One-week change between post-overreaching and post-taper.
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20-m sprint test is used to assess linear speed.
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One-week change between post-overreaching and post-taper.
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Repeated sprint
Lasso di tempo: One-week change between post-overreaching and post-taper.
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20 x 15 m repeated sprint test is used to asses repeated sprint ability.
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One-week change between post-overreaching and post-taper.
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Agility T-test
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Agility T-test is used to assess planned change-of-direction performance.
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One-week change between post-overreaching and post-taper.
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Basketball jump shot accuracy test
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Basketball jump shot accuracy test is used to assess basketball-specific performance.
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One-week change between post-overreaching and post-taper.
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Muscle soreness
Lasso di tempo: One-week change between post-overreaching and post-taper.
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Muscle soreness is assessed subjectively using a visual analog scale, which is represented by a 100 mm line marked 0 (no pain) and 100 (worst imaginable pain).
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One-week change between post-overreaching and post-taper.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jan Kvas, Palacky University
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- FTK_2026_13
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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