NCT07469852

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. 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. Lopes-Silva et al. (2019) 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 caffeine (CAFF), NoPill (NOPILL) or Placebo (PLAC) effects on cognitive and 4-km time-trial (TT) performance. As a diurnal variation in 4-km TT has been widely reported in a similar population. The aim of the present study is to investigate if ingesting caffeine on the day of the morning test, to improve performance.

Trial Health

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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 below P25 for phase_1

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 12, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
12 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

2 months

First QC Date

February 25, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Caffinemorning cognitive performancemorning 4-km time-trial performance

Outcome Measures

Primary Outcomes (8)

  • Morning 4-km time-trial finishing time

    4-km cycling time-trial (Watbike Pro, Nottingham UK) finishing time in minute and seconds. \~ 4-6 minutes.

    From enrolment to last experimental session (~4 weeks)

  • 4-km cycling time-trial split times every 1 km.

    4-km cycling time-trial (Watbike Pro, Nottingham UK) split times (in minutes and seconds) every 1 km.

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

  • Heart rate every 1-km

    Heart rate measured every 1-km during the 4-km time-trial, using a heart rate monitor.

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

  • Rating of perceived exertion every 1-km

    Rating of perceived exertion every 1-km for the 4-km time-trail. Measured on a 6 (no exertion) to 20 (maximal exertion) scale. Takes \~1 s.

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

  • Perceived pacing taken at 2 and 4 km

    Perceived pacing taken at 2 and 4 km of the 4-km time trial. The scale is a 10 cm visual analogue scale where -5 represents pacing to slow to complete the 2 km as fast as possible, zero = optimal pacing and +5 went to fast. Takes \~1 s to answer.

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

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

    To assess the effect of 300 mg caffeine (CAFF) vs placebo (PLAC) vs no-pill (NoPill) on morning Trail Making Test time to completion in seconds (TMT; parts A and B). In part A the circles are numbered 1-25, and the participant is instructed to draw lines to connect the numbers in ascending order. In part B, the circles include both numbers (1-13) and letters (A-L) and the participant is instructed to draw lines to connect the circles in ascending pattern but with the added task of alternating between numbers and letters (i.e., 1-A-2-B-3-C etc.). In both parts the participant is instructed to connect to the circles as fast as possible, without lifting the pencil from the paper. If an error is made, this is pointed out immediately and the participant is allowed to correct it. During the test, time to completion is measured, with a higher time indicative of the greater impairment.

    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)

  • Rectal temperature @rest and after warm-up

    From enrolment to last experimental session (4 weeks)

  • Blood lactate @ rest, pre TT and after

    From enrolment to last experimental session (4 weeks)

  • Mean skin temperature (Tsk)

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

  • The mean body temperature (Tmb)

    From familiarisation to the final 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: Caffeine (300 mg)Other: PlaceboOther: No Pill

Group 2

EXPERIMENTAL

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

Drug: Caffeine (300 mg)Other: PlaceboOther: No Pill

Group 3

EXPERIMENTAL

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

Drug: Caffeine (300 mg)Other: PlaceboOther: No Pill

Interventions

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

Group 1Group 2Group 3
PlaceboOTHER

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.

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)

  • 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
  • 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
  • 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
  • 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

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
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 repeated measures 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 13, 2026

Study Start

January 12, 2026

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