The Effects of a Caffeine Supplement on Cognitive Fatigue After a VR Drive Simulation

NCT07852299 | Not Yet Recruiting

• 1 other identifier: UBrain
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 uBrayn (Tsunami) was selected for use in the present study.

Conditions

Caffeine

Keywords

caffeine; cognitive performance; noothropics supplement

Outcome Measures

Primary Outcomes (1)

• Cogntive Fatigue

  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 uBrayn 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.

  baseline and post drive simulation in the same session for both day 1 and day 2

Study Arms (2)

Ubrain group

EXPERIMENTAL

Ubrain in a supplement containing mostly caffeine and other components. Four pills (daily dose) contain 200 mg of caffeine.

Dietary Supplement: Caffeine supplement

placebo

PLACEBO COMPARATOR

The placebo is composed of maltodextrins. Four pills contain 4 gr of carbohydrate.

Dietary Supplement: Placebo

Interventions

Caffeine supplement DIETARY_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.

Ubrain group

Placebo DIETARY_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 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.

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Department of Biomedical Sciences, University of Padua

Padova, PD, 10034, Italy

Location

Study Officials

• Antonio Paoli

  University of Padua Department of Biomedical Sciences

  STUDY DIRECTOR

Central Study Contacts

Antonio Paoli

CONTACT

0498275318; antonio.paoli@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)