UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063042 |
|---|---|
| Receipt number | R000072167 |
| Scientific Title | Effect of different caffeinated spray administration on aerobic cycling and cognitive performance |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/24 17:27:52 |
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Basic information
Public title
Effects of Combined Caffeine Mouth Rinse and Nasal Spray on Simulated 10-km Cycling and Stroop Outcomes
Acronym
Combined Oral and Nasal Caffeine Administration
Scientific Title
Effect of different caffeinated spray administration on aerobic cycling and cognitive performance
Scientific Title:Acronym
Combined Oral and Nasal Caffeine Administration
Region
| Asia(except Japan) |
Condition
Condition
Healthy, physically active adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine cycling and cognitive responses and early changes in plasma caffeine concentration following combined caffeine mouth rinse and nasal spray administration compared with matched placebo in physically active men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Completion time, measured in seconds, for the simulated 10-km constant-power cycling test performed at 65% of maximal power output. Completion time was recorded directly by the cycle ergometer during each experimental trial.
2. Mean cadence, measured in revolutions per minute, recorded continuously and averaged across the simulated 10-km constant-power cycling test during each experimental trial.
Key secondary outcomes
1. Stroop reaction time for correct responses and response accuracy in the neutral and incongruent conditions, assessed before exercise and immediately after a 3-min active recovery following the cycling test.
2. Heart rate, measured at baseline, at 5 km, and upon completion of the simulated 10-km cycling test.
3. Rating of perceived exertion, assessed at baseline, at 5 km, upon completion, and 1 min after each intervention administration.
4. Immediate post-exercise ratings of nasal discomfort, oral discomfort, gastrointestinal discomfort, and headache, assessed using a 5-point Likert scale.
5. Plasma caffeine concentration, measured before and 1 min after one combined caffeine administration during an optional single-visit substudy involving 11 participants.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Combined caffeine condition: Participants received the combined caffeine intervention twice: during the second minute of the 80-W cycling warm-up and at 5 km of the simulated 10-km cycling test. At each administration, caffeine nasal spray (20 mg/mL) was delivered as two 0.2-mL actuations into each nostril, providing a total volume of 0.8 mL and approximately 16 mg of caffeine. Immediately afterwards, participants rinsed 25 mL of caffeine solution (20 mg/mL; 500 mg caffeine) around the mouth for 5 s, followed by a 5-s oral-clearing period, and expectorated the solution as completely as possible. The mouth-rinse quantity represents oral exposure rather than an ingested dose.
Interventions/Control_2
Combined placebo condition: Participants received the placebo intervention at the same two timepoints and using the same administration procedures. At each administration, placebo nasal spray consisting of distilled water was delivered as two 0.2-mL actuations into each nostril, providing a total volume of 0.8 mL. Participants then rinsed 25 mL of placebo solution containing distilled water and sugar-free orange beverage, without caffeine, around the mouth for 5 s, followed by a 5-s oral-clearing period, and expectorated the solution as completely as possible.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Physically active males.
Previous experience performing exercise in a fasted state.
Provided written informed consent to participate.
Key exclusion criteria
Chronic metabolic or cardiovascular disease.
Nasal pathology.
Current smoking.
Recent musculoskeletal injury.
Habitual caffeine intake greater than 300 mg/day.
Use of supplements or medications that could influence exercise or cognitive function.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hengzhi |
| Middle name | |
| Last name | Deng |
Organization
Universiti Malaya
Division name
Faculty of Sports and Exercise Science
Zip code
50603
Address
Jalan Universiti, 50603 Kuala Lumpur, Malaysia
TEL
175885277
s2198414@siswa.um.edu.my
Public contact
Name of contact person
| 1st name | Hengzhi |
| Middle name | |
| Last name | Deng |
Organization
Universiti Malaya
Division name
Faculty of Sports and Exercise Science
Zip code
50603
Address
Jalan Universiti, 50603 Kuala Lumpur, Malaysia
TEL
175885277
Homepage URL
s2198414@siswa.um.edu.my
Sponsor or person
Institute
Universiti Malaya
Institute
Department
Personal name
Funding Source
Organization
This research received no external funding.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Malaya Research Ethics Committee Non-Medical (UMREC-NM)
Address
Pusat Perkhidmatan Penyelidikan, Level 2, Kompleks Pengurusan Penyelidikan dan Inovasi, Universiti Malaya, 50603 Kuala Lumpur, Malaysia
Tel
+60 3 7967 7022 ext. 2369
umrec@um.edu.my
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Universiti Malaya (Kuala Lumpur, Malaysia)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
Sixteen participants completed both crossover conditions. Combined caffeine administration was associated with a shorter simulated cycling-test completion time and a higher mean cadence than placebo. No condition-specific differences were detected in Stroop performance, heart rate, perceived exertion, or immediate side effects. In the 11-participant substudy, plasma caffeine concentration increased 1 min after administration but remained low.
Results date posted
| 2026 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixteen physically active men participated. Mean +/- SD values were: age, 20.81 +/- 1.94 years; height, 176.85 +/- 5.52 cm; body mass, 69.89 +/- 9.39 kg; BMI, 22.31 +/- 2.67 kg/m2; VO2peak, 46.46 +/- 4.46 mL/kg/min; maximal power, 230.00 +/- 16.89 W; and habitual caffeine intake, 114.08 +/- 54.87 mg/day.
Participant flow
Sixteen participants were enrolled and randomized to the order of the two crossover conditions. All 16 participants completed both the combined caffeine and placebo conditions and were included in the primary analyses. Eleven participants additionally volunteered for the separate single-visit blood substudy.
Adverse events
Immediate side effects assessed were nasal discomfort, oral discomfort, gastrointestinal discomfort, and headache. No statistically significant differences were detected between the combined caffeine and placebo conditions.
Outcome measures
Combined caffeine administration was associated with a shorter completion time during the simulated 10-km constant-power cycling test (977.94 +/- 57.89 vs. 1003.69 +/- 62.90 s; p = 0.015) and a higher mean cadence (102.58 +/- 6.12 vs. 100.03 +/- 5.86 rpm; p = 0.012). No condition-specific differences were detected in Stroop reaction time or accuracy, heart rate, perceived exertion, or immediate side effects. Among 11 blood-substudy participants, plasma caffeine concentration increased from 31.14 +/- 14.73 to 53.89 +/- 25.95 ng/mL at 1 min after administration (p < 0.001).
Plan to share IPD
No
IPD sharing Plan description
De-identified individual participant data will not be deposited in a public repository because of privacy and ethical restrictions. Data may be made available by the corresponding author upon reasonable request, subject to applicable institutional and ethical requirements.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was retrospectively registered after completion of participant recruitment, data collection, and analysis. Ethical approval was obtained before recruitment, and all participants provided written informed consent and underwent preliminary health screening before participation.
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072167
