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
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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.
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.
1,078 studies on the registry are indexed under Hypoxia; 214 are open to participants now.
Browse Hypoxia studies →7 of the 41 studies in Hypoxia with a site in United Kingdom are open now. Recruiting first, the newest first:
University of Manchester · Sites in United Kingdom
Ages 18+
Imperial College London · Sites in United Kingdom
Ages 18–90
Vilnius University · Sites in United Kingdom, Lithuania
Ages 18+
Leeds Beckett University · Sites in United Kingdom
Ages 18–35 · Men only · Healthy volunteers
Steno Diabetes Center Copenhagen · Sites in United Kingdom, Denmark
Ages 18+
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 →
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.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 6 · Phase 3 2 · Phase 4 1
First in 1999; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 45 across 770 interventional studies indexed under Hypoxia.
Median enrollment 23 across the 31 interventional studies, 45 across the 10 observational. Of the 29 that completed or were terminated, 8 (28%) have results posted.
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6 of 41 have an industry lead sponsor. The 10 most frequent:
Liverpool John Moores University is the lead sponsor of 76 studies on the registry; 14 are open to participants now.
Liverpool John Moores University has 1 study filed under Hypoxia — fewer than ten, so there is no comparison to draw.
3 of the studies in Hypoxia with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07936006Liverpool John Moores UniversityEffects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling. | 2027-03-01 |
| NCT06147232Steno Diabetes Center CopenhagenPrevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia | 2027-05 |
| NCT05029258University of ManchesterBiomarkers for Clinical Hypoxia Evaluation in Cervical Cancer | 2027-10-31 |
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Among the 41 studies in Hypoxia with a site in United Kingdom, from their registry updates:
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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.
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.
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.
Exclusion Criteria:
Control, Placebo, Caffeine, 1000m, 2000m,
Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000
Placebo, Caffeine, 1000m, 2000m, Control,
Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000
Caffeine, 1000m, 2000m, Control, Placebo,
Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000
2000m, Control, Placebo, Caffeine, 1000m,
Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000
1000m, 2000m, Control, Placebo, Caffeine, Caffeine,
Drug: Caffeine (300mg) · Other: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) · Other: Control · Other: Hypoxia 1000 · Other: Hypoxia 2000
300 mg of caffeine ingested in form of 3 100 mg capsules 60 minutes prior to testing.
Also known as: Caff, Caffeine
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
No pill control intended to act as a comparator for both Hypoxia and caffeine analysis
Also known as: No pill
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
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
4km time to completion
How long does the participant take to complete 4km cycling
Time frame: 5 weeks
Average power
Average power sustained through the 4km
Time frame: 5 weekas
Cognitive function
Stroop word-colour interference test
Time frame: 5 weeks
Witty
Light reaction test
Time frame: 5 weeks
Memory test
Rey's Auditory Verbal Learning test
Time frame: 5 weeks
Plan to share: No
No publications or documents are linked to this record.
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.
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 ↗
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Studies of the drug tested here: Caffeine
Liverpool John Moores University