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Your journey
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3Review
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More info
You can access this
clinical trial
if you have
Metabolism - Cerebral Energy
and you are
between 65 and 100
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Fermented Papaya Preparation
  • Other: Granulated Sugar
  • Procedure: Magnetic Resonance Spectroscopy
  • Procedure: functional magnetic resonance imaging
  • Behavioral: RAND 36-item Health Survey (SF-36)
  • : Blood Samples
  • Behavioral: Functional Assessment of Chronic Illness Therapy-Fatigue
Tris trial is registered with FDA with number: NCT02771366. The sponsor of the trial is University of Florida and it is looking for 30 volunteers for the current phase.
Official trial title:
The Influence of Fermented Papaya Preparation (FPP) on Cerebral Energy Metabolism, Neuroinflammation, and Cognition in Older Adults