Fermented Papaya and Driving Simulator Older Adult Study

NCT06672874 | Enrolling By Invitation

• 1 other identifier: IRB202401429
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Fermented Papaya; Driving Simulator; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Dietary Supplement: Fermented Papaya Preparation (FPP)

Interventions

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.

Fermented Papaya Preparation (FPP) Intervention Arm

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Osato Research Institute: collaborator

Study Sites (1)

UF Smarthouse

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

fermented papaya preparation

Study Officials

• Sherrilene Classen, PhD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: March 19, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)