NCT07466732

Brief Summary

Athletes often compete in the morning when they are biologically weaker; normally in competition heats or quarterfinals to qualify for the finals scheduled in the evening. Some athletes may even choose to perform at submaximal levels in these qualifying rounds, especially when they are expected to perform multiple times in the same day (such as weightlifting at the Olympic Games). Gross muscular performance such as power output or force production is greater in the evening than the morning (\~3-14% variation). Similarly, time-trial performance and repeated sprint performance (RSP; a good measure of performance in team sport) is \~3 and 5 % greater in the evening than the morning. The reason for this daily variation in performance is attributed to central factors (such as the body clock), as well as motivational and peripheral factors, including higher core and muscle temperatures in the evening compared to the morning. The body clock located within the anterior hypothalamus consists of a group of neurons known as suprachiasmatic nuclei, which are responsible for controlling the rhythm of core temperature. This 'master clock' has an endogenous period (\~24.2 h) slightly longer than the 24-h solar day; therefore, must be entrained by time cues (zeitgebers) to remain in sync with the environment, of these the light-dark cycle is the most powerful in humans. The most efficient nutritional ergogenic is caffeine. Recently caffeine has been investigated to reduce the negative influence of diurnal variations on repeated-sprint ability test (10 × 6 s cycle sprints, with 30 s of rest) at 60 min after ingestion of either 5 mg·kg-1 or placebo. A recent study reported that caffeine supplementation did not prevent the reduction in performance in the morning. However, placebo effect can be 3-5% and hence the use of a No-pill condition would ensure that any placebo effect is accounted for and that the true potential effect of caffeine can be established. To the best of our knowledge, no study has yet investigated a) caffeine (300 mg), NoPill or Placebo (300 mg dextrose) effects on cognitive and physiological morning performance.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 25, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Caffinemorning cognitive performancemorning repeated sprint performance

Outcome Measures

Primary Outcomes (7)

  • Morning repeated sprint performance test

    Morning repeated sprint performance test (10 x 20 m with 30 s recovery) on a vulcanised surfaced runway. With time recorded at 5, 10, 15 and 20 m in seconds.

    From enrolment to last experimental session (~4 weeks)

  • Morning repeated sprint performance test heart rate

    Morning repeated sprint performance test (10 x 20 m with 30 s recovery) on a vulcanised surfaced runway. With heart rate using a heart rate monitor recorded at the end of each sprint. Takes \~ 1 second.

    From familiarisation to the final experimental session (~4 weeks).

  • Rating of perceived exertion every sprint

    Morning repeated sprint performance test (10 x 20 m with 30 s recovery) on a vulcanised surfaced runway. With ratine of perceived exertion recorded at the end of each sprint. Takes \~ 1 second. Measured on a 6 (no exertion) to 20 (maximal exertion) scale.

    From familiarisation to the final experimental session (~4 weeks)

  • Blood lactate and glucose at the end of the 10 sprints

    Blood taken from the finger tip and analysed for lactate and glucose levels in mmols. Takes 10 s.

    From enrolment to last experimental session (4 weeks)

  • Core body temperature

    Ear temperature taken at rest and after the warmup. Measured in degrees Celsius. Takes 3 seconds.

    From enrolment to last experimental session (4 weeks)

  • Morning Rey Auditory Verbal Learning Test

    Rey Auditory Verbal Learning Test: The RAVLT is a neuropsychological assessment designed to evaluate verbal memory. The test is designed as a list-learning paradigm in which the volunteer hears a list of 15 nouns and is asked to recall as many words from the list as possible. The number correct and the number that were given by the participant but not on the list (intrusions) are noted. This process is re-peated 4 more times. The process is repeated but with a second interference list (List B) is presented in the same manner, and the participant is asked to recall as many words as possible from List B and scoring recorded. . After the interference trial, the participant is immediately asked to recall the words from List A, which they heard five times previously and the number of correct words and intrusions are recorded. RAVTL total number, number of dis-tractions and retention are recorded and analysed.

    From familiarisation to the final experimental session (~4 weeks)

  • Morning Stroop word-colour interference test

    Stroop word-colour interference test. The participants were asked to read out their responses to words or colours for 45 s as quickly as possible and to leave no errors uncorrected. This was filmed and the number of errors and total amount completed was recorded and analysed. The first sheet had text (red, blue, yellow, black and green) in black ink (naming word test, W). The second sheet had blocks of colour corresponding to the text on the first sheet (naming colour test, C). With the third sheet, the participants had to read out the word (which was coloured differently to the word, e.g., the word was yellow and the colour red, referred to as the naming colour of word test, CW) and for the fourth sheet, the participants had to read out the colon (which was wrongly named, e.g., the colour was yellow but the word was red, referred to as the naming of word not colour test, WC). In this fourth sheet, the words were printed in the reverse order to the third sheet.

    From familiarisation to the final experimental session (~4 weeks)

Secondary Outcomes (13)

  • Morning grip strength

    Time Frame: From enrolment to last experimental session (4 weeks)

  • Vertical jump (Counter movement Jump and hands on hips - best of 3)

    From enrolment to last experimental session (4 weeks)]

  • Witty Cognitive agility test 2x 90 s

    From enrolment to last experimental session (4 weeks)]

  • Morning Trail Making Test time to completion in seconds (TMT; parts A and B)

    From enrolment to last experimental session (4 weeks)

  • Morning profile of mood states questionnaire

    From familiarisation to the final experimental session (~4 weeks)

  • +8 more secondary outcomes

Study Arms (3)

Group 1

EXPERIMENTAL

1\) NoPill, 2) PLAC, 3) Caffeine (300 mg)

Drug: CaffeineOther: PlacaboOther: No Pill

Group 2

EXPERIMENTAL

1\) PLAC, 22) Caffeine (300 mg) 3) NoPill

Drug: CaffeineOther: PlacaboOther: No Pill

Group 3

EXPERIMENTAL

1\) Caffeine (300 mg) 2) NoPill, 3) PLAC

Drug: CaffeineOther: PlacaboOther: No Pill

Interventions

300mg of of caffeine anhydrous in 3 capsules similar to PLACEBO in size and weight

Group 1Group 2Group 3
PlacaboOTHER

3 capsules of PLACEBO similar to caffeine condition in size and weight

Group 1Group 2Group 3
No PillOTHER

No capsules were given

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults
  • years old
  • Injury-free
  • ≥ 2 years of weight/strength training experience
  • Not receiving any pharmacological treatment (including non-steroidal anti-inflammatory drugs, NSAIDs) throughout the study period
  • Low habitual caffeine consumers (≤ 150mg per day)
  • No preference to training regarding time-of-day

You may not qualify if:

  • Depressed mood (from the Beck depression inventory)
  • Poor sleep quality (a Pittsburgh sleep quality index global score \>5
  • Recent shift work or travel across multiple time-zones
  • 'Extreme' chronotype (assessed via the Composite Morningness Questionnaire
  • Risk factors and/or symptoms of cardiovascular disease.
  • Page 9 of 11 - • Minimal knowledge of the effects of time-of-day or time-since-sleep on human performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Reilly Building (LJMU)

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

Related Publications (4)

  • Walsh NP, Halson SL, Sargent C, Roach GD, Nedelec M, Gupta L, Leeder J, Fullagar HH, Coutts AJ, Edwards BJ, Pullinger SA, Robertson CM, Burniston JG, Lastella M, Le Meur Y, Hausswirth C, Bender AM, Grandner MA, Samuels CH. Sleep and the athlete: narrative review and 2021 expert consensus recommendations. Br J Sports Med. 2020 Nov 3:bjsports-2020-102025. doi: 10.1136/bjsports-2020-102025. Online ahead of print.

    PMID: 33144349BACKGROUND
  • Drust B, Waterhouse J, Atkinson G, Edwards B, Reilly T. Circadian rhythms in sports performance--an update. Chronobiol Int. 2005;22(1):21-44. doi: 10.1081/cbi-200041039.

    PMID: 15865319BACKGROUND
  • Munnilari M, Bommasamudram T, Easow J, Tod D, Varamenti E, Edwards BJ, Ravindrakumar A, Gallagher C, Pullinger SA. Diurnal variation in variables related to cognitive performance: a systematic review. Sleep Breath. 2024 Mar;28(1):495-510. doi: 10.1007/s11325-023-02895-0. Epub 2023 Aug 17.

    PMID: 37589927BACKGROUND
  • Mitchell PJ, Redman JR. Effects of caffeine, time of day and user history on study-related performance. Psychopharmacology (Berl). 1992;109(1-2):121-6. doi: 10.1007/BF02245489.

    PMID: 1365645BACKGROUND

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ben J Edwards, PHD

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both researcher and participants did not know what of the two pill options were caffeine
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Double blinded counterbalanced design with three conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader Chronobiology and Environmental Physiology

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 12, 2026

Study Start

December 8, 2025

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

IPD unavailable due to privacy or ethical restrictions

Locations