- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07852299
The Effects of a Caffeine Supplement (UBrain) on Cognitive Fatigue After a Virtual Reality Drive Simulation
The Effects of the Caffeine Supplement UBrain on Cognitive Fatigue and Performance in Motorsport Athletes After a Virtual Reality Drive Simulation
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Antonio Paoli
- Telefonnummer: 0498275318
- E-post: antonio.paoli@unipd.it
Studieorter
-
-
PD
-
Padova, PD, Italien, 10034
- Department of Biomedical Sciences, University of Padua
-
Kontakt:
- Antonio Paoli
- Telefonnummer: 0498275318
- E-post: antonio.paoli@unipd.it
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: UBrain group
Ubrain in a supplement containing mostly caffeine and other components. Four pills (daily dose) contain 200 mg of caffeine. |
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-jämförare: placebo
The placebo is composed of maltodextrins. Four pills contain 4 gr of carbohydrate. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cognitive Fatigue
Tidsram: 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. |
baseline and post drive simulation in the same session for both day 1 and day 2
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Antonio Paoli, University of Padua Department of Biomedical Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- UBrain
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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