The Efficient Brain Study
Condition: Metabolism - Cerebral Energy
MeSH terms: Neuroinflammatory Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The design of this research study is to conduct a double-blind, randomized,
      placebo-controlled pilot study to determine whether FPP improves cerebral energy metabolism,
      neuroinflammation, systemic inflammation, cognitive function, fatigue, and health-related
      quality of life in older adults.

      Potential participants will participate in a brief 10 minute phone screening that will
      describe the study. If participants meet initial inclusion/exclusion criteria on the phone
      screen, they will be scheduled for an in-person screening visit. Participants will attend
      five (5) in person visits including one Screening Visit performed individually for each
      potential study participant, and four Assessment Visits (V1-V4). Participants will be asked
      to provide a fasting blood sample that will be utilized to evaluate clinical laboratory
      parameters at the Screening visit and all four assessment visits. The participants will
      complete both a treatment and a placebo condition; therefore, a cross-over design will be
      used. After eight (8) weeks on each of these regimens, participants will be asked to complete
      post-treatment outcome assessments at the University of Florida's Institute on Aging -
      Clinical and Translational Research Building (IOA - CTRB). Following the first post-treatment
      test day (V2), participants will complete a six (6) week washout period and will then return
      to the IOA - CTRB to complete the other study arm. The order the participants receive FPP and
      placebo will be determined through randomization
    

Intervention name(s): Fermented Papaya Preparation; Granulated Sugar
Intervention type(s): Drug; Other
Intervention description(s): This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.; This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.
Other intervention name(s): FPP; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuroinflammation; cognitive function; aging adults