- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07562256
Effects of Different Doses of Caffeine on Physical and Cognitive Performance in Female Handball Players
Dose-Dependent Effects of Acute Caffeine Ingestion on Physical and Cognitive Performance in Female Handball Players: A Randomized, Double-Blind, Placebo-Controlled Crossover Study
This study investigates how different doses of caffeine affect physical and cognitive performance in female handball players. Caffeine is widely used as a performance-enhancing substance, but its effects may vary depending on the type of performance and the dose consumed.
In this randomized, double-blind, placebo-controlled crossover study, participants complete three experimental conditions: placebo, low-dose caffeine (3 mg/kg), and moderate-dose caffeine (6 mg/kg). Each participant receives all conditions in a randomized order, with sufficient time between sessions to avoid carryover effects.
The study evaluates three main performance domains relevant to team sports. Physical performance is assessed using an intermittent running test. Cognitive performance is measured using a reaction time task that evaluates attention and inhibitory control. In addition, a throwing test is used to assess sport-specific motor performance.
The main objective is to determine whether caffeine produces dose-dependent improvements and whether these effects differ across physical, cognitive, and technical performance domains. The findings aim to provide practical insights for athletes and coaches regarding optimal caffeine use in team sport settings.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Caffeine is one of the most widely consumed ergogenic aids in sport, known to influence both physiological and cognitive processes primarily through antagonism of adenosine receptors. Although its beneficial effects on endurance performance and alertness are well established, evidence regarding its effects on cognitive control and sport-specific technical skills remains inconsistent, particularly in team sport settings where multiple performance domains interact.
Team sports such as handball require the integration of intermittent high-intensity physical efforts, rapid decision-making, and precise motor execution. These components are not independent; instead, they compete for shared neurocognitive resources, especially under conditions of fatigue. As a result, interventions such as caffeine supplementation may exert domain-specific effects rather than uniform improvements across all aspects of performance.
Despite extensive research on caffeine, most studies have examined either physical or cognitive outcomes in isolation. Furthermore, dose-response relationships remain unclear, with previous findings suggesting that lower doses may be sufficient to enhance physical performance, whereas cognitive outcomes may require higher levels of stimulation. However, limited evidence exists on whether these dose-dependent effects are maintained when multiple performance domains are assessed within the same experimental framework.
The present study addresses this gap by simultaneously evaluating physical, cognitive, and sport-specific motor performance following different doses of caffeine in female handball players. A randomized, double-blind, placebo-controlled crossover design is used to minimize inter-individual variability and improve internal validity. Participants complete three experimental conditions (placebo, low-dose caffeine, and moderate-dose caffeine), each separated by an adequate washout period to reduce potential carryover effects.
The protocol includes standardized procedures to control for confounding factors such as time of day, environmental conditions, and prior physical activity. Testing sessions follow a fixed sequence, beginning with cognitive assessment, followed by a sport-specific throwing task, and concluding with an intermittent running test. This structure is designed to reflect the multi-component demands of team sport performance while maintaining methodological control.
The primary objective is to determine whether caffeine produces dose-dependent effects across different performance domains. Specifically, the study examines whether physical performance improvements occur at lower doses, whether cognitive performance shows greater sensitivity to higher doses, and whether technical motor performance responds differently to caffeine ingestion. By integrating these domains within a single experimental design, the study aims to provide a more ecologically valid understanding of caffeine's ergogenic effects in team sport contexts.
The findings are expected to contribute to evidence-based recommendations for caffeine use in athletes, emphasizing the importance of aligning supplementation strategies with specific performance goals rather than assuming uniform benefits across all domains.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Central
-
Sinop, Central, Turcja (Türkiye), 57100
- Sinop University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Female handball players
- Regular participation in competitive handball training
- Minimum of 3 years of handball training experience
- Free from musculoskeletal injury within the past 6 months
Exclusion Criteria:
- Known caffeine sensitivity or allergy
- Use of medications or supplements that may affect physical or cognitive performance
- Presence of cardiovascular disease
- Presence of metabolic disorders
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Komparator placebo: Placebo Condition
Participants receive placebo capsules prior to testing in a randomized
|
Ingestion of identical capsules containing polydextrose with no active ingredient, administered 60 minutes prior to testing.
|
|
Eksperymentalny: Low-Dose Caffeine
Participants receive 3 mg/kg caffeine prior to testing in a randomized
|
Acute ingestion of caffeine at a dose of 3 mg per kilogram of body mass, administered in capsule form 60 minutes prior to testing.
|
|
Eksperymentalny: Moderate-Dose Caffeine
Participants receive 6 mg/kg caffeine prior to testing in a randomized
|
Acute ingestion of caffeine at a dose of 6 mg per kilogram of body mass, administered in capsule form 60 minutes prior to testing.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Flanker Task Reaction Time
Ramy czasowe: During each experimental session (60 minutes after supplementation)
|
Mean reaction time (ms) during correct trials in the Simplified Eriksen Flanker task, used to assess cognitive processing speed.
|
During each experimental session (60 minutes after supplementation)
|
|
Yo-Yo Intermittent Recovery Test Level 1 Distance
Ramy czasowe: During each experimental session (60 minutes after supplementation)
|
Total distance covered during the Yo-Yo Intermittent Recovery Test Level 1, used to assess intermittent running performance.
|
During each experimental session (60 minutes after supplementation)
|
|
Throwing Velocity
Ramy czasowe: During each experimental session (60 minutes after supplementation)
|
Mean ball velocity (km/h) measured during a standardized handball throwing test.
|
During each experimental session (60 minutes after supplementation)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Flanker Task Accuracy
Ramy czasowe: During each experimental session (60 minutes after supplementation)
|
Percentage of correct responses in the Simplified Eriksen Flanker task.
|
During each experimental session (60 minutes after supplementation)
|
|
Flanker Effect
Ramy czasowe: During each experimental session (60 minutes after supplementation)
|
Difference in reaction time between incongruent and congruent trials in the Flanker task.
|
During each experimental session (60 minutes after supplementation)
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- McLellan TM, Caldwell JA, Lieberman HR. A review of caffeine's effects on cognitive, physical and occupational performance. Neurosci Biobehav Rev. 2016 Dec;71:294-312. doi: 10.1016/j.neubiorev.2016.09.001. Epub 2016 Sep 6.
- Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4.
- Pickering C, Grgic J. Caffeine and Exercise: What Next? Sports Med. 2019 Jul;49(7):1007-1030. doi: 10.1007/s40279-019-01101-0.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SU-2025-688-CAF
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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 .
Badania kliniczne na Placebo
-
SamA Pharmaceutical Co., LtdNieznanyOstre zapalenie oskrzeli | Ostra infekcja górnych dróg oddechowychRepublika Korei
-
National Institute on Drug Abuse (NIDA)ZakończonyUżywanie konopi indyjskichStany Zjednoczone
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyZakończonyMężczyźni z cukrzycą typu II (T2DM)Niemcy
-
AkesoJeszcze nie rekrutacjaAtopowe zapalenie skóryChiny
-
Heptares Therapeutics LimitedZakończonyFarmakokinetyka | Problemy z bezpieczeństwemZjednoczone Królestwo
-
CellmedisMedical Network Sp. z o.o.Jeszcze nie rekrutacja
-
Soroka University Medical CenterZakończony
-
Regado Biosciences, Inc.ZakończonyZdrowy ochotnikStany Zjednoczone
-
West Penn Allegheny Health SystemZakończonyAstma | Alergiczny nieżyt nosaStany Zjednoczone