- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Jakub Krejci, PhD
- Sähköposti: jakub.krejci@upol.cz
Tutki yhteystietojen varmuuskopiointi
- Nimi: Jan Kvas
- Puhelinnumero: +420774678756
- Sähköposti: jan.kvas01@upol.cz
Opiskelupaikat
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Olomouc, Tšekki, 77111
- Rekrytointi
- Palacky University, Faculty of Physical Culture
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Ottaa yhteyttä:
- Jan Kvas
- Puhelinnumero: +420774678756
- Sähköposti: jan.kvas01@upol.cz
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
Muut nimet:
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Placebo Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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RMSSD
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Creatine kinase
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Jan Kvas, Palacky University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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