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Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.

11 listopada 2026 zaktualizowane przez: Ben J. Edwards, PhD, Liverpool John Moores University

This study aims to implement a rigorously standardized protocol to investigate the effect of acute (60 min prior) caffeine intake or hypoxia (1000m and 2000m) on 4km time trial performance.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Time-trial performance is widely regarded as the gold-standard measure of endurance exercise capacity, because successful performance depends on completing a fixed distance in the shortest possible time while effectively regulating pacing strategy and power output. As a result, time-trial performance is considered as one of the most ecologically valid measures of endurance performance in both laboratory investigations and applied sport settings. For many endurance athletes, training and competition frequently occur during the morning due to event scheduling, travel requirements and environmental considerations. However, the morning period is characterised by several time-of-day-related physiological differences that may negatively influence exercise performance. Although systematic reviews have reported substantial variability in the magnitude of diurnal fluctuations in time-trial performance, evidence from well-controlled laboratory studies using fixed-distance protocols under thermoneutral conditions consistently indicates superior performance during the late afternoon or evening. Specifically, improvements in evening performance have been observed across a range of endurance modalities, including 100-m swimming (2.6%), 1-km cycling (2.3%), 4-km cycling (2.6%), 10-km cycling (2.3%), 10-km treadmill running (6.3%), and 16.1-km cycling (3.6%). These findings suggest that morning time-trial performance may be compromised relative to later times-of-day, potentially due to circadian variations in physiological and psychological readiness for exercise. Given that athletes are often required to compete in the morning despite these potential limitations, identifying practical and effective strategies to enhance morning time-trial performance is of considerable interest to athletes, coaches and practitioners seeking to optimise competitive outcomes.

Among the nutritional strategies proposed to improve morning performance, acute caffeine ingestion remains one of the most widely consumed and extensively studied ergogenic aids. Caffeine (1,3,7-trimethylxanthine) primarily exerts its performance-enhancing effects through antagonism of adenosine receptors in the central nervous system, resulting in increased arousal, reduced perceptions of fatigue, and enhanced neurotransmitter activity, including dopamine and noradrenaline. These neurophysiological effects collectively promote wakefulness, attention and central motor drive, thereby facilitating exercise performance. Consistent with these mechanisms, substantial evidence demonstrates that caffeine can improve endurance exercise capacity and time-trial performance across a variety of exercise modalities. Despite the well-established ergogenic effects of caffeine, research examining its efficacy during morning time-trial exercise remains comparatively limited. Interpretation of the available literature is further complicated by several methodological shortcomings, including inconsistent caffeine dosing protocols, inadequate familiarisation procedures and poor control of habitual caffeine intake. Recognising the importance of habitual caffeine consumption as a moderator of physiological and performance responses, recent classification thresholds have been proposed. Categorising individuals as naïve (<25 mg·day-¹), low (25 mg·day-¹ to 0.99 mg·kg-¹·day-¹), mild (1.00-2.99 mg·kg-¹·day-¹), moderate (3.00-5.99 mg·kg-¹·day-¹), high (6.00-8.99 mg·kg-¹·day-¹), and very high (>9.00 mg·kg-¹·day-¹) caffeine consumers. Failure to adequately characterise and control habitual caffeine intake may therefore contribute to the variability observed across studies.

Additional methodological limitations within the existing literature include the absence of both placebo and no-pill comparator conditions, together with insufficient control of key chronobiological variables such as chronotype, sleep quality, habitual training time, and seasonal influences. These factors are particularly relevant given their established influence on exercise performance and their potential to confound assessments of both circadian variation and caffeine-related ergogenic effects. Indeed, recent systematic reviews have identified substantial methodological heterogeneity and risk of bias across chronobiology studies, highlighting the need for more rigorous and standardised experimental designs when investigating time-of-day effects on exercise performance. Consequently, well-controlled studies are required to determine whether acute caffeine ingestion can meaningfully attenuate the physiological disadvantages associated with morning endurance exercise and improve time-trial performance under ecologically valid conditions.

Therefore, the primary aim of the present study was to determine whether the ergogenic effects of acute caffeine (CAFF) ingestion, administered 60-min before exercise, enhance morning 4-km cycling time-trial performance when evaluated when behavioural, methodological and chronobiological confounders were carefully controlled. Habitual caffeine consumers with an intake of >150 mg·day-¹ were recruited to minimise the potential influence of caffeine tolerance and withdrawal, while maximising the physiological response to the administered 300 mg caffeine dose. Secondary outcomes included measures of core and skin temperature, ratings of perceived exertion (RPE), mood-state and physiological responses to exercise.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 30 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Age: 18-30 years old
  • Healthy (as determined by the pre-participation questionnaire)
  • >2 years aerobically trained individuals
  • Consume >150 mg/day of caffeine
  • Be able to stick to the retiring and waking schedule of the study as well as no exercise 24 h before and no caffeine.

Exclusion Criteria:

  • Age: <18 or >30 years old
  • Consume <150 mg/day of caffeine hence caffeine naïve
  • Those with a history of significant side effects after the consumption of caffeine.
  • Deemed unhealthy/unable to perform exercise determined by PAR-Q
  • Shift worker or having travelled out of the UK time zone within the last month of testing
  • Muscle related injury or broken/fractured bone within the past 3 years Diagnosed sleep disorder

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: ABCDE

Control, Placebo, Caffeine, 1000m, 2000m,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Inne nazwy:
  • Kofeina
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Inne nazwy:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Inne nazwy:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Inne nazwy:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Inne nazwy:
  • 2000 m
Eksperymentalny: BCDEA

Placebo, Caffeine, 1000m, 2000m, Control,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Inne nazwy:
  • Kofeina
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Inne nazwy:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Inne nazwy:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Inne nazwy:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Inne nazwy:
  • 2000 m
Eksperymentalny: CDEAB

Caffeine, 1000m, 2000m, Control, Placebo,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Inne nazwy:
  • Kofeina
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Inne nazwy:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Inne nazwy:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Inne nazwy:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Inne nazwy:
  • 2000 m
Eksperymentalny: DEABC

2000m, Control, Placebo, Caffeine, 1000m,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Inne nazwy:
  • Kofeina
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Inne nazwy:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Inne nazwy:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Inne nazwy:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Inne nazwy:
  • 2000 m
Eksperymentalny: EABCD

1000m, 2000m, Control, Placebo, Caffeine, Caffeine,

300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.

Inne nazwy:
  • Kofeina
  • Caff

Placebo capsules made to resemble caffeine. 3 pills the same size as caffeine but filled with maltodextrin (~1.6 g)

Inne nazwy:
  • placebo
  • Pla
  • plac

No pill control intended to act as a comparator for both Hypoxia and caffeine analysis

Inne nazwy:
  • No pill

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 1000 m altitude.

Inne nazwy:
  • 1000m

Hypoxia intervention ran in a controlled environmental chamber on site. Set oxygen partial concentration to similar levels at 2000 m altitude.

Inne nazwy:
  • 2000 m

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
4km time to completion
Ramy czasowe: 5 weeks

How long does the participant take to complete 4km cycling

5 weeks
Average power
Ramy czasowe: 5 weekas

Average power sustained through the 4km

5 weekas

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cognitive function
Ramy czasowe: 5 weeks

Stroop word-colour interference test

5 weeks
Witty
Ramy czasowe: 5 weeks

Light reaction test

5 weeks
Memory test
Ramy czasowe: 5 weeks

Rey's Auditory Verbal Learning test

5 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 listopada 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

5 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 listopada 2026

Pierwszy wysłany (Rzeczywisty)

13 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 261020LJMUSPSREC348

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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 .