Fermented Papaya and Driving Simulator Older Adult Study (NCT06672874) | Clinical Trial Compass
CompletedNot Applicable
Fermented Papaya and Driving Simulator Older Adult Study
United States34 participantsStarted 2025-03-19
Plain-language summary
Yes, this additional detail will refine the original template content to emphasize the study's specific aims and hypotheses. Here's an updated version:
The goal of this clinical trial is to assess if Fermented Papaya Preparation (FPP) can enhance driving performance and reduce driving errors in community-dwelling older adults aged 70-80, who serve as their own controls. The main questions it aims to answer are:
Does FPP reduce the total number of driving errors, particularly those related to psychomotor performance? Does FPP improve driving-related cognitive functions, such as divided attention, working memory, reaction time, and executive function? How do FPP dosage, timing, and acute effects impact driving performance in adults aged 65 and older?
Participants will:
Consume three doses of FPP (3 grams per dose) within 24 hours, with the final dose administered before the simulator driving test.
Complete a high-fidelity driving simulation to assess the association between FPP use and driving errors that predict on-road performance.
Undergo baseline and post-FPP cognitive assessments to compare psychomotor performance and cognitive functions after FPP administration.
Who can participate
Age range
70 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 70 and 80 years.
* Community-dwelling and independent in daily living activities.
* Holds a valid driver's license and has driven in the last 3 months.
* Proficient in reading, writing, and speaking English.
* Physically able to participate in a driving simulation.
* Willing to comply with the study requirements, including FPP dosing and simulator sessions.
Exclusion Criteria:
* Currently taking psychoactive medications.
* Diagnosed with a physical disability that impairs driving ability.
* History of upper extremity amputation or right lower extremity amputation.
* Scores below 18/30 on the Montreal Cognitive Assessment (MoCA).
* Exhibits symptoms of severe simulator sickness after an initial test session.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Driving Errors Related to Cognitive Functions
Timeframe: Baseline, within 24 hours post-FPP administration, and at 8-week follow-up.