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Starting soon Not applicable

The Effects of a Caffeine Supplement (UBrain) on Cognitive Fatigue After a Virtual Reality Drive Simulation

NCT07852299 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-10
Last updated
2026-10-05

Condition(s) studied

Caffeine

Investigational drug(s) / intervention(s)

Caffeine supplementPlacebo

Caffeine supplement: Participants will attend the laboratory and undergo a battery of cognitive tests using electroencephalography (EEG) (Go/No-Go task, psychomotor vigilance test (PVT), Open-Closed eyes). Subsequently, participants will receive the Ubrain supplement. Participants will then complete a virtual reality (VR)-based driving simulator intervention, consisting of a total of 40 minutes of simulated driving. Finally, the same tests described above will be repeated to assess the effects of the dietary supplement on cognitive fatigue. After a one-week washout period, the treatment groups will be reversed.

Placebo: Participants will attend the laboratory and undergo a battery of cognitive tests using electroencephalography (EEG) (Go/No-Go task, psychomotor vigilance test (PVT), Open-Closed eyes). Subsequently, participants will receive the placebo. Participants will then complete a virtual reality (VR)-based driving simulator intervention, consisting of a total of 40 minutes of simulated driving. Finally, the same tests described above will be repeated to assess the effects of the dietary supplement on cognitive fatigue. After a one-week washout period, the treatment groups will be reversed.

Study summary

Motorsport drivers are now widely recognized as athletes in their own right, as they are required to cope with levels of physical and psychological stress comparable to those experienced in more conventional sports. However, cognitive function appears to play a particularly crucial role in motorsport athletes. Indeed, in competitive automobile racing, the ability to achieve and maintain high speeds depends to a large extent on cognitive information-processing abilities rather than solely on physical parameters.

Although these motor-cognitive abilities can be enhanced through specific training and coaching programs targeting both physical and psychological domains, to date, few studies in the scientific literature have investigated the potential psychophysiological benefits of sports supplementation in motorsport athletes. One aspect that warrants further investigation is the use of dietary supplements containing caffeine and nootropic compounds. Indeed, these supplementation has been shown to potentially enhance executive functions and working memory at the central level.

Therefore, the investigation of novel supplementation strategies with potential ergogenic effects on the psychophysiological performance of motorsport drivers remains important for optimizing both central and peripheral adaptations in this specific athletic population. To this end, the dietary supplement (UBrain) was selected for use in the present study.

Eligibility

Sex
MALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria: * No evidence of cognitive impairment, defined as a final score of ≥26 on the Montreal Cognitive Assessment (MoCA). * Previous experience with on-track driving and/or driving simulation Exclusion Criteria: * Medical history, signs, or symptoms of severe, uncontrolled, or unstable diabetes mellitus or cardiovascular, respiratory, hepatic, renal, thyroid, neurological, neuromuscular, peripheral vascular, or autoimmune disease.

Primary outcome measure(s)

  • Cognitive Fatigue — baseline and post drive simulation in the same session for both day 1 and day 2
    Cognitive fatigue will be assessed by examining changes in functional connectivity derived from the eyes-open and eyes-closed EEG recordings. Specifically, connectivity measures obtained before and after the driving simulation will be compared to evaluate changes associated with the 40-minute VR driving task. In addition, post-simulation connectivity measures will be compared between the placebo and UBrain conditions to determine whether supplementation attenuates or modulates the neurophysiological changes associated with prolonged cognitive demand. This approach is based on the rationale that sustained cognitive load and mental fatigue may be accompanied by alterations in functional brain connectivity, reflecting changes in the organization and efficiency of large-scale neural networks involved in attention, executive control, and information processing.

Trial sites (1)

FacilityCityRegionStatus
Department of Biomedical Sciences, University of Padua Padova PD
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07852299 on ClinicalTrials.gov ↗ ← All trials in Italy