HealthyFPPNCT06672874
Fermented Papaya and Driving Simulator Older Adult Study
A study testing Fermented Papaya Preparation (FPP) in people with Healthy, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fermented Papaya Preparation (FPP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the detailed description
This study, titled "Fermented Papaya and Driving Simulator Older Adult Study," investigates the association between Fermented Papaya Preparation (FPP) and driving performance in adults aged 70-80 using a high-fidelity driving simulator. With the aging population growing and driving safety as a critical issue among older adults, this study aims to determine whether FPP-a known antioxidant with anti-inflammatory properties-can enhance cognitive functions essential for safe driving, including attention, working memory, reaction time, and executive functions.
Participants will undergo three driving assessments in the simulator: a baseline test, a short-term follow-up (within 24 hours after FPP administration), and a long-term follow-up at 8 weeks. Each participant acts as their own control, providing comparative data on FPP's effects over time. The primary endpoints include reductions in driving errors associated with psychomotor performance and improvements in divided attention and executive functions.
Technical Aspects and Measures:
Simulator Setup and Scenario: The RTI high-fidelity simulator used in this study provides a realistic and controlled driving environment, replicating common on-road scenarios such as lane changes, reactions to environmental cues, and avoidance maneuvers. Scenarios are randomized to control for learning effects.
Visual and Cognitive Testing: Standardized tests, such as the Montreal Cognitive Assessment and the Useful Field of View, will measure baseline cognitive abilities and potential changes following FPP administration.
Simulator Sickness Management: To ensure comfort, a simulator sickness protocol is in place, including pre-study dietary recommendations and a controlled lab environment with ventilation and temperature settings.
This study could yield significant data on FPP's impact on driving skills, supporting the potential for nutraceutical interventions in promoting driving safety and independence among older adults.
- Conditions
- Healthy
- Being tested
- Fermented Papaya Preparation (FPP)
- Keywords
- Fermented Papaya, Driving Simulator, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Papaya Preparation (FPP)Dietary supplement
Fermented Papaya Preparation (FPP) is administered in this study as a dietary supplement aimed at assessing its potential benefits for cognitive function and driving performance in older adults. Participants consume FPP as a 3-gram powder dose taken orally three times daily (morning, afternoon, evening) for a total of 8 weeks. FPP is known for its antioxidant and anti-inflammatory properties, which may influence cognitive domains essential for safe driving, such as attention, memory, reaction time, and executive function. This intervention is specifically designed to explore FPP's potential impact on reducing driving errors and improving psychomotor skills in a high-fidelity driving simulation environment.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Papaya Preparation (FPP) Intervention Arm | Experimental | Participants in this single-arm study will receive Fermented Papaya Preparation (FPP), administered as a 3-gram dose taken three times daily (morning, afternoon, and evening) for 8 weeks. Assessments will be conducted at three time points: baseline, within 24 hours after initial FPP administration (short-term), and after 8 weeks (long-term). This arm investigates the association between FPP and driving performance, focusing on cognitive and psychomotor functions such as attention, memory, reaction time, and executive function using a high-fidelity driving simulator. Receives: Dietary Supplement: Fermented Papaya Preparation (FPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Driving Errors Related to Cognitive Functions
The primary outcome measure for this study is the reduction in total driving errors in a high-fidelity driving simulator, with a focus on errors related to cognitive functions essential for safe driving, such as divided attention, reaction time, working memory, and executive function. This outcome will assess whether Fermented Papaya Preparation (FPP) impacts cognitive and psychomotor performance related to driving safety.
Measured: Baseline, within 24 hours post-FPP administration, and at 8-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start19 Mar 2025
- Primary completion23 Apr 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants in this single-group study will receive the same intervention, Fermented Papaya Preparation (FPP). Each participant will serve as their own control, allowing comparisons between their baseline (pre-FPP) driving performance and subsequent assessments following FPP administration. Participants will complete three assessments in a high-fidelity driving simulator at baseline, short-term (within 24 hours post-FPP), and long-term (after 8 weeks of FPP use) to evaluate changes in cognitive functions and driving performance over time.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Osato Research Institute
- Responsible party
- Sponsor
- Investigators
- Sherrilene Classen, PhD, MPH, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672874
- Sponsor's protocol ID
- IRB202401429
- Acronym
- FPP
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fermented Papaya and Driving Simulator Older Adult Study
- ClinicalTrials.gov ID
- NCT06672874
- Acronym / sponsor ID
- FPP / IRB202401429
- Conditions
- Healthy
- Keywords
- Fermented Papaya, Driving Simulator, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Osato Research Institute
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study, titled "Fermented Papaya and Driving Simulator Older Adult Study," investigates the association between Fermented Papaya Preparation (FPP) and driving performance in adults aged 70-80 using a high-fidelity driving simulator. With the aging population growing and driving safety as a critical issue among older adults, this study aims to determine whether FPP-a known antioxidant with anti-inflammatory properties-can enhance cognitive functions essential for safe driving, including attention, working memory, reaction time, and executive functions.
Participants will undergo three driving assessments in the simulator: a baseline test, a short-term follow-up (within 24 hours after FPP administration), and a long-term follow-up at 8 weeks. Each participant acts as their own control, providing comparative data on FPP's effects over time. The primary endpoints include reductions in driving errors associated with psychomotor performance and improvements in divided attention and executive functions.
Technical Aspects and Measures:
Simulator Setup and Scenario: The RTI high-fidelity simulator used in this study provides a realistic and controlled driving environment, replicating common on-road scenarios such as lane changes, reactions to environmental cues, and avoidance maneuvers. Scenarios are randomized to control for learning effects.
Visual and Cognitive Testing: Standardized tests, such as the Montreal Cognitive Assessment and the Useful Field of View, will measure baseline cognitive abilities and potential changes following FPP administration.
Simulator Sickness Management: To ensure comfort, a simulator sickness protocol is in place, including pre-study dietary recommendations and a controlled lab environment with ventilation and temperature settings.
This study could yield significant data on FPP's impact on driving skills, supporting the potential for nutraceutical interventions in promoting driving safety and independence among older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants in this single-group study will receive the same intervention, Fermented Papaya Preparation (FPP). Each participant will serve as their own control, allowing comparisons between their baseline (pre-FPP) driving performance and subsequent assessments following FPP administration. Participants will complete three assessments in a high-fidelity driving simulator at baseline, short-term (within 24 hours post-FPP), and long-term (after 8 weeks of FPP use) to evaluate changes in cognitive functions and driving performance over time.
| Arm | Type | Receives |
|---|---|---|
| Fermented Papaya Preparation (FPP) Intervention Arm | Experimental | Dietary Supplement: Fermented Papaya Preparation (FPP)Participants in this single-arm study will receive Fermented Papaya Preparation (FPP), administered as a 3-gram dose taken three times daily (morning, afternoon, and evening) for 8 weeks. Assessments will be conducted at three time points: baseline, within 24 hours after initial FPP administration (short-term), and after 8 weeks (long-term). This arm investigates the association between FPP and driving performance, focusing on cognitive and psychomotor functions such as attention, memory, reaction time, and executive function using a high-fidelity driving simulator. |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented Papaya Preparation (FPP)Fermented Papaya Preparation (FPP) is administered in this study as a dietary supplement aimed at assessing its potential benefits for cognitive function and driving performance in older adults. Participants consume FPP as a 3-gram powder dose taken orally three times daily (morning, afternoon, evening) for a total of 8 weeks. FPP is known for its antioxidant and anti-inflammatory properties, which may influence cognitive domains essential for safe driving, such as attention, memory, reaction time, and executive function. This intervention is specifically designed to explore FPP's potential impact on reducing driving errors and improving psychomotor skills in a high-fidelity driving simulation environment. | Dietary supplement | Fermented Papaya Preparation (FPP) Intervention Arm |
Primary outcome
Reduction in Driving Errors Related to Cognitive Functions
Time frame: Baseline, within 24 hours post-FPP administration, and at 8-week follow-up.
The primary outcome measure for this study is the reduction in total driving errors in a high-fidelity driving simulator, with a focus on errors related to cognitive functions essential for safe driving, such as divided attention, reaction time, working memory, and executive function. This outcome will assess whether Fermented Papaya Preparation (FPP) impacts cognitive and psychomotor performance related to driving safety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherrilene Classen, PhD, MPH principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Papaya Preparation (FPP) in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Driving Errors Related to Cognitive Functions (time frame: Baseline, within 24 hours post-FPP administration, and at 8-week follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.