ClinicalTrials.gg
RecruitingNCT07936006Updated Nov 13, 2026

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

A Phase 4 interventional study of Caffeine (300mg) and Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) in Caffeine, Hypoxia and Placebo - Control, sponsored by Liverpool John Moores University. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Liverpool John Moores University · Phase 4, Interventional, and Other

Updated Nov 13, 2026Newly registeredGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 41 studies in Hypoxia with a site in United Kingdom — 7 open to participants now, 8 under way, none of them phase 3. Hypoxia · United Kingdom.

Planned enrollment
21st of 31
20 · median 23
Started
2026
the only one that year
Phase 4
Only one
of the 41
Registered
41st of 41
by date

Among the 41 studies in Hypoxia with a site in United Kingdom, this one is the 21st largest by planned enrollment of the 31 interventional ones that give a count, is the only one that started in 2026, is the only one in phase 4, and was the 41st registered.

Hypoxia

1,078 studies on the registry are indexed under Hypoxia; 214 are open to participants now.

Browse Hypoxia studies →

Open to participants now

7 of the 41 studies in Hypoxia with a site in United Kingdom are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 126 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 46 (37%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.

This study: 18 Years to 30 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies in Hypoxia with a site in United Kingdom, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Caffeine
  • Hypoxia
  • Placebo - Control

Browse trials for

Keywords

  • Randomised
  • Counterbalanced
04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    ABCDE

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

    Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000

  • Experimental
    BCDEA

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

    Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000

  • Experimental
    CDEAB

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

    Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000

  • Experimental
    DEABC

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

    Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000

  • Experimental
    EABCD

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

    Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000

Interventions

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

    Also known as: Caff, Caffeine

  • OtherPlacebo (caffeine, paracetamol, cephalexin, or ibuprofen)

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

    Also known as: Pla, plac, placebo

  • OtherControl

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

    Also known as: No pill

  • OtherHypoxia 1000

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

    Also known as: 1000m

  • OtherHypoxia 2000

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

    Also known as: 2000 m

06

What researchers measure

Primary outcomes

  1. 4km time to completion

    How long does the participant take to complete 4km cycling

    Time frame: 5 weeks

  2. Average power

    Average power sustained through the 4km

    Time frame: 5 weekas

Secondary outcomes

  1. Cognitive function

    Stroop word-colour interference test

    Time frame: 5 weeks

  2. Witty

    Light reaction test

    Time frame: 5 weeks

  3. Memory test

    Rey's Auditory Verbal Learning test

    Time frame: 5 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2027, 3 months later.

Of 17 phase 4 interventional studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 13, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936006
Lead sponsor
Liverpool John Moores University
Responsible party
Ben J. Edwards, PhD (Dr, Liverpool John Moores University) — Principal investigator
First posted
Nov 13, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Ben J Edwards, PhD
Contact
B.J.Edwards@ljmu.ac.uk
01519046238

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Caffeine

Start the discussion