CaffeineNCT05995314
Effects Of Caffeine On Cognitive Performance
A study testing 3 mg/kg of caffeine and 6 mg/kg of caffeine in people with Caffeine, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Caffeine is a potent central nervous system stimulant that increases the activity in the prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills can lead to further benefits in athletic performance. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- 3 mg/kg of caffeine and 6 mg/kg of caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 7 Aug 2023to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active individuals ( >150 min/week moderate physical activity or >75 min/week vigorous physical activity)
- Individuals without serious and undiagnosed health problems.
Who cannot join
- Individuals with color blindness.
- Regular caffeine consumers (>3 cups of coffee/day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Different Doses Of Caffeine On Cognitive Performance In Healthy Physically Active Individuals
Caffeine is a potent central nervous system stimulant that increases the activity in the prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills can lead to further benefits in athletic performance. Therefore, it is necessary to clarify the dose-response of caffeine on cognitive performance.The aim of this research will be to determine the effects of different doses of caffeine on sport-related cognitive aspects.
Read the detailed description
The investigators will require healthy, physically active young adults to complete three trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In each trial, different cognitive abilities will be assessed using the following test batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer), sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side effects and the perceived sensation index will be recorded 24 h after each test.
- Conditions
- Caffeine
- Being tested
- PLACEBO, 3 mg/kg of caffeine, 6 mg/kg of caffeine
- Keywords
- ergogenic aid, sport performance, reaction time, anticipation, attention, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLACEBODietary supplement
3 mg/kg of cellulose (0 mg/kg of caffeine)
3 mg/kg of caffeineDietary supplement
Ingestion of 3 mg/kg of body mass of caffeine
6 mg/kg of caffeineDietary supplement
Ingestion of 6 mg/kg of body mass of caffeine
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | placebo (0 mg/kg of body mass of caffeine). The capsule will be filled with 3 mg/kg of body mass of cellulose. Receives: Dietary Supplement: PLACEBO |
| 3mg/kg | Experimental | 3 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom). Receives: Dietary Supplement: 3 mg/kg of caffeine |
| 6mg/kg | Experimental | 6 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom). Receives: Dietary Supplement: 6 mg/kg of caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time
Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.
Measured: 10 minutes
Anticipation
Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.
Measured: 5 minutes
Sustained attention
The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and "Eriksen Flanker Test" [congruent and incongruent reaction time (in seconds)].
Measured: 10 minutes
Memory
To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start7 Aug 2023
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Abián-Vicén, PhD, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995314
- Sponsor's protocol ID
- CAF_MR_2023
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramirez-delaCruz M, Esteban-Garcia P, Abian P, Bravo-Sanchez A, Pinas-Bonilla I, Abian-Vicen J. Effects of different doses of caffeine on cognitive performance in healthy physically active individuals. Eur J Nutr. 2024 Dec;63(8):3025-3035. doi: 10.1007/s00394-024-03486-9. Epub 2024 Sep 4.
PubMed 39231871
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Different Doses Of Caffeine On Cognitive Performance In Healthy Physically Active Individuals
- ClinicalTrials.gov ID
- NCT05995314
- Acronym / sponsor ID
- CAF_MR_2023
- Conditions
- Caffeine
- Keywords
- ergogenic aid, sport performance, reaction time, anticipation, attention, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caffeine is a potent central nervous system stimulant that increases the activity in the prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills can lead to further benefits in athletic performance. Therefore, it is necessary to clarify the dose-response of caffeine on cognitive performance.The aim of this research will be to determine the effects of different doses of caffeine on sport-related cognitive aspects.
Detailed description
The investigators will require healthy, physically active young adults to complete three trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In each trial, different cognitive abilities will be assessed using the following test batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer), sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side effects and the perceived sensation index will be recorded 24 h after each test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Dietary Supplement: PLACEBOplacebo (0 mg/kg of body mass of caffeine). The capsule will be filled with 3 mg/kg of body mass of cellulose. |
| 3mg/kg | Experimental | Dietary Supplement: 3 mg/kg of caffeine3 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom). |
| 6mg/kg | Experimental | Dietary Supplement: 6 mg/kg of caffeine6 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically active individuals ( >150 min/week moderate physical activity or >75 min/week vigorous physical activity)
- Individuals without serious and undiagnosed health problems.
Key exclusion criteria (2 listed)
- Individuals with color blindness.
- Regular caffeine consumers (>3 cups of coffee/day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLACEBO3 mg/kg of cellulose (0 mg/kg of caffeine) | Dietary supplement | PLACEBO |
| 3 mg/kg of caffeineIngestion of 3 mg/kg of body mass of caffeine | Dietary supplement | 3mg/kg |
| 6 mg/kg of caffeineIngestion of 6 mg/kg of body mass of caffeine | Dietary supplement | 6mg/kg |
Primary outcome
Reaction Time
Time frame: 10 minutes
Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.
Anticipation
Time frame: 5 minutes
Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.
Sustained attention
Time frame: 10 minutes
The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and "Eriksen Flanker Test" [congruent and incongruent reaction time (in seconds)].
Memory
Time frame: 20 minutes
To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 39231871Ramirez-delaCruz M, Esteban-Garcia P, Abian P, Bravo-Sanchez A, Pinas-Bonilla I, Abian-Vicen J. Effects of different doses of caffeine on cognitive performance in healthy physically active individuals. Eur J Nutr. 2024 Dec;63(8):3025-3035. doi: 10.1007/s00394-024-03486-9. Epub 2024 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Abián-Vicén, PhD study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 mg/kg of caffeine and 6 mg/kg of caffeine in people with Caffeine, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.