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Fermented Papaya and Driving Simulator Older Adult Study

NCT06672874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-07-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sherrilene Classen, PhD, MPH · University of Florida

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2026-04-23
Completion
2026-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672874 on ClinicalTrials.gov