The Efficient Brain Study
Condition: Metabolism - Cerebral Energy
MeSH terms: Neuroinflammatory Diseases
Intervention: Fermented Papaya Preparation; Granulated Sugar
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 65 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: neuroinflammation; cognitive function; aging adults

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to participate in all aspects of the study;

          -  Not confined to a wheelchair;

          -  Evidence of cognitive aging based on Montreal Cognitive Assessment score less than or
             equal to 28, but greater than or equal to 23;

          -  Presence of elevated levels of systemic inflammation at screening (C-reactive protein
             levels > 1.0)

          -  Able to swallow study product as directed.

        Exclusion Criteria:

          -  Failure to give consent;

          -  Active treatment for cancer (< 3 years);

          -  Stroke (< 6 mo);

          -  Serious heart condition, peripheral vascular disease, coronary artery disease
             (myocardial infarction<6 mo), Class III, IV Congestive Heart Failure;

          -  Dementia (e.g., Alzheimer's disease)

          -  Severe anemia (Hgb < 8.0 g/dL);

          -  Any blood or bleeding disorders;

          -  Liver or renal disease;

          -  Diabetes;

          -  Severe osteoarthritis;

          -  Anticoagulant therapy (aspirin use is permitted);

          -  Parkinson's disease;

          -  Severe psychiatric disease or psychological disorder (e.g., severe depression,
             bi-polar disorder, schizophrenia) or current use of antipsychotics;

          -  Current use of anabolic medications (e.g., growth hormone or testosterone) or
             anticholinesterase inhibitor (i.e., Aricept);

          -  High amounts of physical activity (i.e., running, bicycling, etc.) > 120 min/week;

          -  Excessive alcohol use (>2 drinks per day);

          -  Use of tobacco products;

          -  Resting heart rate > 120 bpm;

          -  History of significant head injury leading to cognitive impairments;

          -  Visual or hearing impairments that would interfere with testing;

          -  Allergies to papaya or foods with similar compounds (i.e., banana, avocado, kiwi,
             chestnuts, hazel nuts)

          -  Allergy to latex;

          -  Participating in another clinical trial or has received an investigational product
             within 30 days prior to screening/enrollment;

          -  Center for Epidemiological Studies - Depression Scale (CES-D) Score > 20.