- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Antonio Paoli
- Telefonnummer: 0498275318
- E-post: antonio.paoli@unipd.it
Studiesteder
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PD
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Padova, PD, Italia, 10034
- Department of Biomedical Sciences, University of Padua
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Ta kontakt med:
- Antonio Paoli
- Telefonnummer: 0498275318
- E-post: antonio.paoli@unipd.it
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
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Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cognitive Fatigue
Tidsramme: baseline and post drive simulation in the same session for both day 1 and day 2
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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
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Antonio Paoli, University of Padua Department of Biomedical Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- UBrain
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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