Fermented Papaya and Driving Simulator Older Adult Study (FPP)

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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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Fermented Papaya Preparation (FPP)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Smarthouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fermented Papaya Preparation (FPP) Intervention Arm; 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.

Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, within 24 hours post-FPP administration, and at 8-week follow-up.

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Osato Research Institute
• Investigators: Principal Investigator: Sherrilene Classen, PhD, MPH, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): April 23, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Driving Simulator; Fermented Papaya
• Additional Relevant MeSH Terms: fermented papaya preparation
• Other Study ID Numbers: IRB202401429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No