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

11 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Merseyside
      • Liverpool, Merseyside, Regno Unito, L3 3AF
        • Reclutamento
        • Tom Reilly Building
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 30 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ABCDE

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

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

Altri nomi:
  • Caffeina
  • Caff

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

Altri nomi:
  • placebo
  • Pla
  • plac

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

Altri nomi:
  • No pill

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

Altri nomi:
  • 1000m

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

Altri nomi:
  • 2000 m
Sperimentale: BCDEA

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

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

Altri nomi:
  • Caffeina
  • Caff

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

Altri nomi:
  • placebo
  • Pla
  • plac

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

Altri nomi:
  • No pill

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

Altri nomi:
  • 1000m

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

Altri nomi:
  • 2000 m
Sperimentale: CDEAB

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

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

Altri nomi:
  • Caffeina
  • Caff

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

Altri nomi:
  • placebo
  • Pla
  • plac

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

Altri nomi:
  • No pill

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

Altri nomi:
  • 1000m

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

Altri nomi:
  • 2000 m
Sperimentale: DEABC

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

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

Altri nomi:
  • Caffeina
  • Caff

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

Altri nomi:
  • placebo
  • Pla
  • plac

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

Altri nomi:
  • No pill

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

Altri nomi:
  • 1000m

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

Altri nomi:
  • 2000 m
Sperimentale: EABCD

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

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

Altri nomi:
  • Caffeina
  • Caff

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

Altri nomi:
  • placebo
  • Pla
  • plac

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

Altri nomi:
  • No pill

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

Altri nomi:
  • 1000m

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

Altri nomi:
  • 2000 m

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
4km time to completion
Lasso di tempo: 5 weeks

How long does the participant take to complete 4km cycling

5 weeks
Average power
Lasso di tempo: 5 weekas

Average power sustained through the 4km

5 weekas

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cognitive function
Lasso di tempo: 5 weeks

Stroop word-colour interference test

5 weeks
Witty
Lasso di tempo: 5 weeks

Light reaction test

5 weeks
Memory test
Lasso di tempo: 5 weeks

Rey's Auditory Verbal Learning test

5 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 novembre 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

5 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 261020LJMUSPSREC348

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .