- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05995314
Effects Of Caffeine On Cognitive Performance
September 4, 2023 updated by: University of Castilla-La Mancha
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toledo, Spain, 45071
- Performance and Sport Rehabilitation Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Physically active individuals ( >150 min/week moderate physical activity or >75 min/week vigorous physical activity)
- Individuals without serious and undiagnosed health problems.
Exclusion Criteria:
- Individuals with color blindness.
- Regular caffeine consumers (>3 cups of coffee/day).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: PLACEBO
placebo (0 mg/kg of body mass of caffeine).
The capsule will be filled with 3 mg/kg of body mass of cellulose.
|
3 mg/kg of cellulose (0 mg/kg of caffeine)
|
Experimental: 3mg/kg
3 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).
|
Ingestion of 3 mg/kg of body mass of caffeine
|
Experimental: 6mg/kg
6 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).
|
Ingestion of 6 mg/kg of body mass of caffeine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
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.
|
5 minutes
|
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)].
|
10 minutes
|
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.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Javier Abián-Vicén, PhD, University of Castilla-La Mancha
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2023
Primary Completion (Actual)
September 4, 2023
Study Completion (Actual)
September 4, 2023
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 8, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 4, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAF_MR_2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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