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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 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02771366
The ClinicalTrials.gov registry entry for NCT02771366 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fermented Papaya Preparation is the first listed.
NCT02771366 reports 0 study locations.
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.
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