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

11 november 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Merseyside
      • Liverpool, Merseyside, Verenigd Koninkrijk, L3 3AF
        • Werving
        • Tom Reilly Building
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 30 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ABCDE

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

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

Andere namen:
  • Cafeïne
  • Caff

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

Andere namen:
  • placebo
  • Pla
  • plac

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

Andere namen:
  • No pill

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

Andere namen:
  • 1000m

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

Andere namen:
  • 2000 m
Experimenteel: BCDEA

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

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

Andere namen:
  • Cafeïne
  • Caff

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

Andere namen:
  • placebo
  • Pla
  • plac

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

Andere namen:
  • No pill

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

Andere namen:
  • 1000m

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

Andere namen:
  • 2000 m
Experimenteel: CDEAB

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

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

Andere namen:
  • Cafeïne
  • Caff

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

Andere namen:
  • placebo
  • Pla
  • plac

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

Andere namen:
  • No pill

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

Andere namen:
  • 1000m

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

Andere namen:
  • 2000 m
Experimenteel: DEABC

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

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

Andere namen:
  • Cafeïne
  • Caff

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

Andere namen:
  • placebo
  • Pla
  • plac

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

Andere namen:
  • No pill

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

Andere namen:
  • 1000m

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

Andere namen:
  • 2000 m
Experimenteel: EABCD

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

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

Andere namen:
  • Cafeïne
  • Caff

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

Andere namen:
  • placebo
  • Pla
  • plac

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

Andere namen:
  • No pill

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

Andere namen:
  • 1000m

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

Andere namen:
  • 2000 m

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
4km time to completion
Tijdsspanne: 5 weeks

How long does the participant take to complete 4km cycling

5 weeks
Average power
Tijdsspanne: 5 weekas

Average power sustained through the 4km

5 weekas

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cognitive function
Tijdsspanne: 5 weeks

Stroop word-colour interference test

5 weeks
Witty
Tijdsspanne: 5 weeks

Light reaction test

5 weeks
Memory test
Tijdsspanne: 5 weeks

Rey's Auditory Verbal Learning test

5 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 november 2026

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

5 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

11 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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