Fermented Papaya for Cognitive Function in Older Adults

(FPP Trial)

Overseen By Hongwu Wang, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Psychoactive medications

Disqualifiers: Physical disability, Amputation, Low MoCA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Fermented Papaya Preparation (FPP) for cognitive function in older adults?

Research suggests that Fermented Papaya Preparation (FPP) may help reduce oxidative stress (damage caused by harmful molecules) in Alzheimer's patients, which is linked to brain health. Additionally, FPP has shown potential in protecting brain cells from damage related to Alzheimer's disease in laboratory studies. ^{1 2 3 4 5}

Is Fermented Papaya Preparation (FPP) safe for human use?

Fermented Papaya Preparation (FPP) has been shown to be safe in clinical trials with older adults, with no serious adverse effects reported and no significant changes in blood chemistry or inflammation markers. It has also been widely used without genotoxic effects (no damage to genetic material) in cell studies, and no toxicity was observed in specific cell types. ^{1 6 7 8 9}

How does Fermented Papaya Preparation (FPP) differ from other treatments for cognitive function in older adults?

Fermented Papaya Preparation (FPP) is unique because it acts as an antioxidant, reducing oxidative stress, which is linked to Alzheimer's disease. Unlike many conventional treatments, FPP is a natural supplement derived from fermented papaya, and it has shown potential in improving cell viability and reducing harmful reactive oxygen species in the brain. ^{1 4 5 6 10}

What is the purpose of this trial?

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.

Research Team

Sherrilene Classen, PhD, MPH

Principal Investigator

University of Florida

Eligibility Criteria

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

Proficient in reading, writing, and speaking English

I live at home and can take care of my daily needs by myself.

Willing to comply with the study requirements, including FPP dosing and simulator sessions

Exclusion Criteria

I am currently on medication for my mental health.

I have had an amputation of an arm or my right leg.

I have a physical disability that affects my ability to drive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline driving assessment in the simulator and cognitive testing

1 day

1 visit (in-person)

Treatment

Participants consume three doses of Fermented Papaya Preparation (FPP) daily for 8 weeks

8 weeks

Daily self-administration

Short-term Follow-up

Participants complete a driving simulation and cognitive assessments within 24 hours after initial FPP administration

1 day

1 visit (in-person)

Long-term Follow-up

Participants undergo a final driving simulation and cognitive assessments at 8 weeks

1 day

1 visit (in-person)

Treatment Details

Interventions

• Fermented Papaya Preparation (FPP)

Trial Overview The study tests if Fermented Papaya Preparation (FPP) improves driving performance in older adults. Participants will take FPP doses before undergoing a driving simulation to measure errors and complete cognitive assessments to evaluate psychomotor functions.

Participant Groups

Group I: Fermented Papaya Preparation (FPP) Intervention Arm Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Osato Research Institute

Collaborator

Trials

7

Recruited

470+

References

1. United States pubmed.ncbi.nlm.nih.gov

Oxidative stress in patients with Alzheimer's disease: effect of extracts of fermented papaya powder. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Hawaiian native herb Mamaki prevents dementia by ameliorating neuropathology and repairing neurons in four different mouse models of neurodegenerative diseases. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Phytochemicals from Fermented Food Sources in Alzheimer's Disease In Vivo Experimental Models: A Systematic Review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Fermented papaya preparation attenuates beta-amyloid precursor protein: beta-amyloid-mediated copper neurotoxicity in beta-amyloid precursor protein and beta-amyloid precursor protein Swedish mutation overexpressing SH-SY5Y cells. [2013]

5. India pubmed.ncbi.nlm.nih.gov

The protective effect and underlying mechanism of Hainan papaya water extract against neuronal apoptosis induced by Aβ40. [2018]

6. France pubmed.ncbi.nlm.nih.gov

Effects of Fermented Papaya Preparation (FPP) on Safety Outcomes in Older Adults - A Short Report of a Placebo-Controlled Clinical Trial. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

Applications and bioefficacy of the functional food supplement fermented papaya preparation. [2010]

8. Italy pubmed.ncbi.nlm.nih.gov

Plasma glucose level decreases as collateral effect of fermented papaya preparation use. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

A 2-year Double-Blind RCT Follow-up Study with Fermented Papaya Preparation (FPP) Modulating Key Markers in Middle-Age Subjects with Clustered Neurodegenerative Disease-Risk Factors. [2020]

10. Singapore pubmed.ncbi.nlm.nih.gov

A comparative study of anti-aging effects of Carica papaya (pulp and seeds) on D-galactose-induced brain aging in albino rats. [2022]