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NCT02771366 · ClinicalTrials.gov registry record · Phase 2
The Efficient Brain Study
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02771366: Completed Phase 2 study, sponsored by University of Florida.
NCT02771366 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02771366, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Cerebral energy metabolism declines with advanced aging, and is implicated in age-related cognitive decline, Alzheimer's disease (AD), and other forms of neurodegenerative disease (Parkinson's disease). In addition, age-associated increase in systemic and neuroinflammation is associated with a higher likelihood for development of Alzheimer's disease and neurodegenerative disease in older adults. Furthermore, decreased cerebral energy metabolism and increased neuroinflammation are both associated with deficits in cognitive function, even in the absence of neurodegenerative disease. In older adults, decreased cognition is strongly associated with the development of AD, increased rates of hospitalization, loss of functional independence, and increased mortality rate. Novel methods for preventing cognitive decline and neurodegenerative diseases in older adults are needed the world's aging population. Current research suggests that nutrients in fruits and vegetables produce strong anti-oxidant and anti-proliferative effects. Most Americans are not consuming the minimum recommendations of fruits and vegetables per day to receive these benefits. Whole food-based nutritional products, such as Fermented Papaya Product (FPP), may provide a healthy alternative for individuals. FPP, which is made by bio-fermentation of Carica papaya, has been found to enhance antioxidant protection and to decrease DNA damage in healthy older adults. Furthermore, if FPP increases cerebral energy metabolism and down-regulates neuroinflammation, with resulting effects on cognition, dietary supplementation with FPP may have preventative benefits for age-related cognitive conditions, including MCI, AD, Parkinson's disease and other neurodegenerative diseases.
Primary Outcome
Cerebral energy metabolism will be defined by phosphorus magnetic resonance spectroscopy markers of ATP/mitochondrial function in brain tissue (α-ATP, β-ATP, and γ-ATP). Within-subject crossover design; difference between drug and placebo arms. Treatment duration: weeks 0-8 followed by washout then weeks 14 to 22. Data reported in the outcome measures data table represents difference between pre and post measurement values (post-pre) for each arm.
Interventions
- DRUG Fermented Papaya Preparation
- OTHER Granulated Sugar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-07-27 |
| Phase | Phase 2 |
What the finished NCT02771366 record still lists
NCT02771366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Fermented Papaya Preparation is the first listed.
NCT02771366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02771366 about?
NCT02771366 is a clinical study titled "The Efficient Brain Study". Cerebral energy metabolism declines with advanced aging, and is implicated in age-related cognitive decline, Alzheimer's disease (AD), and other forms of neurodegenerative disease (Parkinson's disease). In addition, age-associated increase in systemic and neuroinflammation is associated with a highe...
What is the current status of trial NCT02771366?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2016-11. Estimated completion is 2018-07-27.
What interventions are being tested in trial NCT02771366?
The interventions under investigation include: Fermented Papaya Preparation (DRUG), Granulated Sugar (OTHER).
Who is sponsoring clinical trial NCT02771366?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02771366's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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