Fermented Papaya for Cognitive Function in Older Adults
(FPP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Fermented Papaya Preparation (FPP) can help older adults improve their driving skills and reduce mistakes on the road. It specifically examines whether FPP can enhance mental abilities such as attention, memory, reaction time, and decision-making, all crucial for safe driving. Individuals aged 70-80 who live independently, hold a valid driver's license, and have driven recently are suitable candidates for this study. Participants will take FPP and then engage in driving simulations to assess any improvements. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cognitive health and driving safety for older adults.
Do I have to stop taking my current medications for the trial?
If you are currently taking psychoactive medications, you cannot participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What prior data suggests that Fermented Papaya Preparation (FPP) is safe for older adults?
Research has shown that Fermented Papaya Preparation (FPP) is generally safe for use. In past studies, participants who took FPP did not report any major side effects, suggesting the supplement is safe for long-term use. FPP is also available as a dietary supplement, indicating its prior use without significant safety issues. However, while these results are encouraging, they are based on past research and not specifically on this trial. Those with concerns or existing health conditions should consult a doctor before joining the trial.
Why are researchers excited about this trial?
Unlike standard treatments for cognitive decline, which often include medications like donepezil or lifestyle changes aimed at overall health, Fermented Papaya Preparation (FPP) stands out because it is a natural dietary supplement. Researchers are excited about FPP because it is believed to boost cognitive functions by harnessing the antioxidant properties of fermented papaya, potentially improving attention, memory, and reaction time without the side effects commonly associated with pharmaceuticals. Additionally, FPP's straightforward administration—three times daily—makes it an easy addition to a daily routine, offering a novel way to support cognitive health in older adults.
What evidence suggests that Fermented Papaya Preparation (FPP) might be an effective treatment for improving cognitive function in older adults?
Research suggests that Fermented Papaya Preparation (FPP) might aid brain function. Some studies have found that FPP has antioxidant effects, protecting brain cells from harm. This protection might enhance memory and focus. In earlier studies, participants who took FPP performed better on tasks requiring concentration and quick thinking. This trial will examine the link between FPP and driving performance, focusing on cognitive and psychomotor functions such as attention, memory, reaction time, and executive function in older adults. While the results are encouraging, further research is needed to determine how effectively FPP can improve driving-related cognitive skills in this population.
Who Is on the Research Team?
Sherrilene Classen, PhD, MPH
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for healthy older adults aged 70-80 who are active drivers, can manage daily activities independently, and have no physical disabilities affecting driving. They must not be on psychoactive meds or have cognitive impairments as indicated by a MoCA score below 18.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a baseline driving assessment in the simulator and cognitive testing
Treatment
Participants consume three doses of Fermented Papaya Preparation (FPP) daily for 8 weeks
Short-term Follow-up
Participants complete a driving simulation and cognitive assessments within 24 hours after initial FPP administration
Long-term Follow-up
Participants undergo a final driving simulation and cognitive assessments at 8 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Fermented Papaya Preparation (FPP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Osato Research Institute
Collaborator